<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02239601</url>
  </required_header>
  <id_info>
    <org_study_id>H2014:281</org_study_id>
    <nct_id>NCT02239601</nct_id>
  </id_info>
  <brief_title>Chemotherapy Induced Peripheral Neuropathy. Could Physical Therapy Help Treat Symptoms?</brief_title>
  <official_title>Chemotherapy - Induced Peripheral Neuropathy (CIPN). Could There be a Role for Physical Therapy Treatment?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CancerCare Manitoba</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Manitoba</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>CancerCare Manitoba</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The cause of Chemotherapy-Induced Peripheral Neuropathy (CIPN) is still unknown. An estimated&#xD;
      55-60% of patients will experience lasting symptoms affecting function for years&#xD;
      post-treatment. Physical therapy is an established, effective treatment for entrapped nerves&#xD;
      and neuropathic pain. This study sought to identify additional risk factors and provide&#xD;
      evidence for the role of physical therapy in the treatment of CIPN.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A common side effect is chemotherapy induced peripheral neuropathy (CIPN). CIPN is a small&#xD;
      fibre sensory neuropathy that develops in the hands/feet and worsens with increasing dose and&#xD;
      duration of treatment. It impacts the Aβ, Aδ, and C-Fiber function involved in light touch&#xD;
      and vibration sense, thermal detection and thermal pain. This results in a variety of&#xD;
      positive and/or negative sensory symptoms including hypoesthesia, dysesthesias, hyperalgesia,&#xD;
      allodynia and neuropathic pain. Quantitative sensory testing (QST) are a variety of&#xD;
      non-invasive tests aimed at quantifying sensory perceptions used in research to clinically&#xD;
      assess neuropathy. It is used for sensory detection and pain thresholds for both mechanical&#xD;
      and thermal stimuli. QST provides information on large myelinated (Aβ), small thinly&#xD;
      myelinated (Aδ) and unmyelinated (C-fiber) function or dysfunction. Deep pressure threshold&#xD;
      measured by a pressure algometry stimulates intramuscular afferents, and can be used as a&#xD;
      measure of central sensitization when used at a distant site from the site of pain. Aδ fibres&#xD;
      transmit cool detection threshold, while warm detection threshold is transmitted by C-fibers.&#xD;
      Both noxious heat and noxious cold transmit via C-fiber and Aδ fibers. An increased&#xD;
      sensitivity to thermal pain thresholds, results in thermal hyperalgesia.&#xD;
&#xD;
      Physical therapy treatment for nerve disorders is well established in orthopedics and plastic&#xD;
      surgery for entrapment neuropathies, neuropathic pain, post-operative nerve repair and&#xD;
      regeneration. Nerve gliding exercises are frequently used exercises in physical therapy to&#xD;
      improve neural excursion across joints, improve pain and decrease inflammation. Patient&#xD;
      reported symptoms (patient questionnaires NPRS, S-LANSS and DASH) and quantitative sensory&#xD;
      testing (QST) specifically pain pressure thresholds and vibration were used for the primary&#xD;
      purpose in evaluating the role for an upper extremity nerve mobilization physical therapy&#xD;
      home program during chemotherapy for the prevention and management of CIPN.&#xD;
&#xD;
      Primary Outcome Measures was the NPRS and reported as those having no vs no pain. Grip&#xD;
      strength, Vibration, DASH and S-LANSS were identified outcome measures prior to the trial&#xD;
      that would best describe sensory impairment and function for the physical therapy question&#xD;
&#xD;
      Additional QST measures collected included warm/cool, Hot/Cold Pain thresholds that were used&#xD;
      with the vibration data to compare quantitative data on the right and left side to evaluate&#xD;
      possible a possible dual nerve disorder when combined with surgery as well as identifying&#xD;
      different sensory profiles of QST data between those reporting neuropathic pain and&#xD;
      non-neuropathic pain using the S-LANSS&#xD;
&#xD;
      A sub analysis of data was completed dividing participants that remained active throughout&#xD;
      compared to less active participants to evaluate the effect of exercise on sensory&#xD;
      preservation. This was not an intended analysis at the beginning of the trial and these&#xD;
      participants were not randomized.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2014</start_date>
  <completion_date type="Actual">November 2017</completion_date>
  <primary_completion_date type="Actual">November 1, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants With 'Pain' or 'no Pain' as Measured by the Numeric Pain Rating Scale</measure>
    <time_frame>Regression models of pain reported over time (mid-docetaxel chemotherapy- 6 months post-chemotherapy). Mid-chemotherapy time frame participants were re-assessed after the 2 round of TC and 4th round of FECD.</time_frame>
    <description>Numeric Pain Rating Scale - pain rating scale 0-10 (0= no pain to 10= most pain imaginable). Reported as percentages of participants with pain (1-10) vs no pain (0)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Disability of the Arm, Shoulder and Hand (DASH)</measure>
    <time_frame>administered on each re-assessment (pre-chemotherapy, mid-way through docetaxel chemotherapy, end of chemotherapy, 6 months post-chemotherapy) and mixed models accounted for all time points</time_frame>
    <description>A 30 item participant reported questionnaire commonly used to gauge upper limb function. Each item is scored 1-5 with 1 being 'no difficulty' and 5 being 'unable'. Overall score calculated as: [average response (sum of responses divided by number of responses) -1] x 25 to give a score out of 100. Minimum score is 30 with a maximum score of 150. The DASH was chosen because of high test-retest reliability and the responsiveness and construct validity in patients with breast cancer over other quality of life measures. A minimal clinical important difference is a change score of 15. Higher score indicates more impairment to the upper limb</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Neuropathic Pain Defined by the Self Report Version of Leeds Assessment for Neuropathic Symptoms and Signs (S-LANSS).</measure>
    <time_frame>administered on each re-assessment (Visit 1 - pre-chemotherapy, Visit 2 - half-way through chemotherapy, Visit 3 - end of chemotherapy, Visit 4 - 3 months post-chemotherapy) and mixed models accounted for all time points</time_frame>
    <description>a 7 item patient reported questionnaire and was used to confirm the presence of neuropathic pain. The score ranges from 0-19 (no symptoms=0, sever symptoms=19) with a score above 12 indicative of neuropathic pain/symptoms. S-LANSS was chosen because of its' specificity and accuracy in a cancer population. Participants were requested to answer specifically for the hands, not feet.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Vibration Sensory Analysis</measure>
    <time_frame>administered on each re-assessment (Visit 1 - pre-chemotherapy, Visit 2 - half-way through chemotherapy, Visit 3 - end of chemotherapy, Visit 4 - 6 months post-chemotherapy) and mixed models accounted for all time points</time_frame>
    <description>Vibration analysis testing for perception thresholds are specific to Aβ nerve fibres. The TSAII Vibration Sensory Analyzer (VSA): Medoc, Israel, was used. The pulp of the index finger lightly touches the sensor that delivers random and varying vibration amplitudes (µm). The participant responds &quot;yes/no&quot; to sensing the vibration. Vibration perception was selected for its sensitivity and has been suggested to be the first clinical sign of CIPN symptoms and was tested bilaterally. Low score indicates better perception while a higher score is poorer sensation. Perception score reported in micrometers (up to 4cm)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Pressure Thresholds</measure>
    <time_frame>administered on each re-assessment (Visit 1 - pre-chemotherapy, Visit 2 - half-way through chemotherapy, Visit 3 - end of chemotherapy, Visit 4 - 6 months post-chemotherapy) and mixed models accounted for all time points</time_frame>
    <description>Pressure Algometry (Somedic AB, Sweden) measured pressure/pain thresholds. A hand-held device applied perpendicular to the muscles being tested. Increasing pressure is applied until the participant determines that the sensation has changed from a feeling of pressure to a feeling of pain and force (Kpa) is recorded. When tested at a distant site from the source of pain this test measures central sensitization. Lower pressure values (more sensitive to noxious stimuli) suggest impaired central pain and/or diminished descending inhibition pathway. The left quadriceps muscle was tested as a measure of central sensitization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Grip Strength</measure>
    <time_frame>administered on each re-assessment (Visit 1 - pre-chemotherapy, Visit 2 - half-way through chemotherapy, Visit 3 - end of chemotherapy, Visit 4 - 6 months post-chemotherapy) and mixed models accounted for all time points</time_frame>
    <description>Hand Dynamometry records grip strength in kgs and was used as a measure of function (3 trials). The dominant hand was tested using the Jamar dynamometer (Patterson medical, USA) in the 2nd handle position. All 48 participants were right handed.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">61</enrollment>
  <condition>Breast Cancer</condition>
  <condition>Peripheral Neuropathy, Secondary to Drugs or Chemicals</condition>
  <arm_group>
    <arm_group_label>Physical Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>4 Physical therapy treatment sessions provided prior to chemotherapy and a home program to continue throughout the trial.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Physical Therapy</intervention_name>
    <description>Physical therapy assessment and treatment for any positive signs of nerve entrapment prior to chemotherapy including nerve gliding exercises, education and splinting. A home program was provided and continued throughout chemotherapy treatment</description>
    <arm_group_label>Physical Therapy</arm_group_label>
    <other_name>physiotherapy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients diagnosed with stage I-III breast cancer undergoing regular docetaxel&#xD;
             treatment either docetaxel-cyclophosphamide (TC) or&#xD;
             5FU-epirubicin-cyclophosphamide-docetaxel (FEC-D).&#xD;
&#xD;
          -  Patients that have not had chemotherapy in the past and do not have identified risk&#xD;
             factors (listed below in the exclusion criteria).&#xD;
&#xD;
          -  All patients must be able to communicate in english or be able to have a translator&#xD;
             present at all appointments.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients diagnosed with stage IV breast cancer or who have co-morbid conditions that&#xD;
             are known to cause peripheral neuropathic symptoms, including previous chemotherapy,&#xD;
             exposure to toxins (such as lead), Diabetes, Shingles, B12 deficiency, Alcoholism,&#xD;
             Lyme disease, Syphilis, HIV, Hereditary disorders such as Charcot-Marie Tooth.&#xD;
&#xD;
          -  Patients not planned to receive Docetaxel therapy.&#xD;
&#xD;
          -  Patients who cannot communicate in English and unable to bring an interpreter will&#xD;
             also be excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Barbara L Shay, PhD</last_name>
    <role>Study Director</role>
    <affiliation>University of Manitoba</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Elizabeth R Hammond, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Manitoba</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rehabilitation Hospital, Health Sciences Centre, 800 Sherbrook St</name>
      <address>
        <city>Winnipeg</city>
        <state>Manitoba</state>
        <zip>R3A 1M4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>September 10, 2014</study_first_submitted>
  <study_first_submitted_qc>September 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 15, 2014</study_first_posted>
  <results_first_submitted>June 2, 2018</results_first_submitted>
  <results_first_submitted_qc>September 19, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">October 9, 2019</results_first_posted>
  <last_update_submitted>September 19, 2019</last_update_submitted>
  <last_update_submitted_qc>September 19, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 9, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>CancerCare Manitoba</investigator_affiliation>
    <investigator_full_name>Dr. Marshall Pitz</investigator_full_name>
    <investigator_title>Medical Oncologist and Associate Professor , University of Manitoba</investigator_title>
  </responsible_party>
  <keyword>Physical Therapy</keyword>
  <keyword>Physiotherapy</keyword>
  <keyword>Breast Cancer</keyword>
  <keyword>Chemotherapy Induced Peripheral Neuropathy (CIPN)</keyword>
  <keyword>Nerve gliding exercises</keyword>
  <keyword>Nerve Entrapment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Peripheral Nervous System Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 2, 2014</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/01/NCT02239601/ICF_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 1, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/01/NCT02239601/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Physical Therapy</title>
          <description>4 Physical therapy treatment sessions provided prior to chemotherapy and a home program to continue throughout the trial.&#xD;
Physical Therapy: Physical therapy assessment and treatment for any positive signs of nerve entrapment prior to chemotherapy including nerve gliding exercises, education and splinting. A home program will be provided to continue throughout chemotherapy treatment</description>
        </group>
        <group group_id="P2">
          <title>Control</title>
          <description>treatment as usual</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="29"/>
                <participants group_id="P2" count="32"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="26"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Physical Therapy</title>
          <description>4 Physical therapy treatment sessions provided prior to chemotherapy and a home program to continue throughout the trial.&#xD;
Physical Therapy: Physical therapy assessment and treatment for any positive signs of nerve entrapment prior to chemotherapy including nerve gliding exercises, education and splinting. A home program will be provided to continue throughout chemotherapy treatment</description>
        </group>
        <group group_id="B2">
          <title>Control</title>
          <description>treatment per usual</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="22"/>
            <count group_id="B2" value="26"/>
            <count group_id="B3" value="48"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="22"/>
                    <count group_id="B2" value="26"/>
                    <count group_id="B3" value="48"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="46"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="22"/>
                    <count group_id="B2" value="26"/>
                    <count group_id="B3" value="48"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="48"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With 'Pain' or 'no Pain' as Measured by the Numeric Pain Rating Scale</title>
        <description>Numeric Pain Rating Scale - pain rating scale 0-10 (0= no pain to 10= most pain imaginable). Reported as percentages of participants with pain (1-10) vs no pain (0)</description>
        <time_frame>Regression models of pain reported over time (mid-docetaxel chemotherapy- 6 months post-chemotherapy). Mid-chemotherapy time frame participants were re-assessed after the 2 round of TC and 4th round of FECD.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Physical Therapy</title>
            <description>4 Physical therapy treatment sessions provided prior to chemotherapy and a home program to continue throughout the trial.&#xD;
Physical Therapy: Physical therapy assessment and treatment for any positive signs of nerve entrapment prior to chemotherapy including nerve gliding exercises, education and splinting. A home program will be provided to continue throughout chemotherapy treatment</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>chemotherapy as usual without physical therapy</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With 'Pain' or 'no Pain' as Measured by the Numeric Pain Rating Scale</title>
          <description>Numeric Pain Rating Scale - pain rating scale 0-10 (0= no pain to 10= most pain imaginable). Reported as percentages of participants with pain (1-10) vs no pain (0)</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Percentage of Participants with Pain (1-10)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                    <measurement group_id="O2" value="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percentage of Participants with no pain (0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70"/>
                    <measurement group_id="O2" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.053</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.41</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.17</ci_lower_limit>
            <ci_upper_limit>1.01</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Disability of the Arm, Shoulder and Hand (DASH)</title>
        <description>A 30 item participant reported questionnaire commonly used to gauge upper limb function. Each item is scored 1-5 with 1 being 'no difficulty' and 5 being 'unable'. Overall score calculated as: [average response (sum of responses divided by number of responses) -1] x 25 to give a score out of 100. Minimum score is 30 with a maximum score of 150. The DASH was chosen because of high test-retest reliability and the responsiveness and construct validity in patients with breast cancer over other quality of life measures. A minimal clinical important difference is a change score of 15. Higher score indicates more impairment to the upper limb</description>
        <time_frame>administered on each re-assessment (pre-chemotherapy, mid-way through docetaxel chemotherapy, end of chemotherapy, 6 months post-chemotherapy) and mixed models accounted for all time points</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Physical Therapy</title>
            <description>4 Physical therapy treatment sessions provided prior to chemotherapy along with a home program to continue throughout the trial.&#xD;
Physical Therapy: Physical therapy assessment and treatment for any positive signs of nerve entrapment prior to chemotherapy (baseline) including nerve gliding exercises, education and splinting. A home program was provided and continued throughout chemotherapy treatment.</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Chemotherapy as usual- no physical therapy intervention</description>
          </group>
        </group_list>
        <measure>
          <title>Disability of the Arm, Shoulder and Hand (DASH)</title>
          <description>A 30 item participant reported questionnaire commonly used to gauge upper limb function. Each item is scored 1-5 with 1 being 'no difficulty' and 5 being 'unable'. Overall score calculated as: [average response (sum of responses divided by number of responses) -1] x 25 to give a score out of 100. Minimum score is 30 with a maximum score of 150. The DASH was chosen because of high test-retest reliability and the responsiveness and construct validity in patients with breast cancer over other quality of life measures. A minimal clinical important difference is a change score of 15. Higher score indicates more impairment to the upper limb</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34" lower_limit="31" upper_limit="45"/>
                    <measurement group_id="O2" value="42" lower_limit="33" upper_limit="52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Neuropathic Pain Defined by the Self Report Version of Leeds Assessment for Neuropathic Symptoms and Signs (S-LANSS).</title>
        <description>a 7 item patient reported questionnaire and was used to confirm the presence of neuropathic pain. The score ranges from 0-19 (no symptoms=0, sever symptoms=19) with a score above 12 indicative of neuropathic pain/symptoms. S-LANSS was chosen because of its' specificity and accuracy in a cancer population. Participants were requested to answer specifically for the hands, not feet.</description>
        <time_frame>administered on each re-assessment (Visit 1 - pre-chemotherapy, Visit 2 - half-way through chemotherapy, Visit 3 - end of chemotherapy, Visit 4 - 3 months post-chemotherapy) and mixed models accounted for all time points</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Physical Therapy</title>
            <description>4 Physical therapy treatment sessions provided prior to chemotherapy and a home program to continue throughout the trial.&#xD;
Physical Therapy: Physical therapy assessment and treatment for any positive signs of nerve entrapment prior to chemotherapy including nerve gliding exercises, education and splinting. A home program will be provided to continue throughout chemotherapy treatment</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>treatment as usual</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Neuropathic Pain Defined by the Self Report Version of Leeds Assessment for Neuropathic Symptoms and Signs (S-LANSS).</title>
          <description>a 7 item patient reported questionnaire and was used to confirm the presence of neuropathic pain. The score ranges from 0-19 (no symptoms=0, sever symptoms=19) with a score above 12 indicative of neuropathic pain/symptoms. S-LANSS was chosen because of its' specificity and accuracy in a cancer population. Participants were requested to answer specifically for the hands, not feet.</description>
          <units>percentage of patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Percentage of patients with non-neuropathic visits</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83.9"/>
                    <measurement group_id="O2" value="74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percentage of Patients with Neuropathic visits</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.1"/>
                    <measurement group_id="O2" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Vibration Sensory Analysis</title>
        <description>Vibration analysis testing for perception thresholds are specific to Aβ nerve fibres. The TSAII Vibration Sensory Analyzer (VSA): Medoc, Israel, was used. The pulp of the index finger lightly touches the sensor that delivers random and varying vibration amplitudes (µm). The participant responds &quot;yes/no&quot; to sensing the vibration. Vibration perception was selected for its sensitivity and has been suggested to be the first clinical sign of CIPN symptoms and was tested bilaterally. Low score indicates better perception while a higher score is poorer sensation. Perception score reported in micrometers (up to 4cm)</description>
        <time_frame>administered on each re-assessment (Visit 1 - pre-chemotherapy, Visit 2 - half-way through chemotherapy, Visit 3 - end of chemotherapy, Visit 4 - 6 months post-chemotherapy) and mixed models accounted for all time points</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Physical Therapy</title>
            <description>4 Physical therapy treatment sessions provided prior to chemotherapy and a home program to continue throughout the trial.&#xD;
Physical Therapy: Physical therapy assessment and treatment for any positive signs of nerve entrapment prior to chemotherapy including nerve gliding exercises, education and splinting. A home program will be provided to continue throughout chemotherapy treatment</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>chemotherapy as usual without physical therapy</description>
          </group>
        </group_list>
        <measure>
          <title>Vibration Sensory Analysis</title>
          <description>Vibration analysis testing for perception thresholds are specific to Aβ nerve fibres. The TSAII Vibration Sensory Analyzer (VSA): Medoc, Israel, was used. The pulp of the index finger lightly touches the sensor that delivers random and varying vibration amplitudes (µm). The participant responds &quot;yes/no&quot; to sensing the vibration. Vibration perception was selected for its sensitivity and has been suggested to be the first clinical sign of CIPN symptoms and was tested bilaterally. Low score indicates better perception while a higher score is poorer sensation. Perception score reported in micrometers (up to 4cm)</description>
          <units>micrometers (µm)</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Left Hand</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.23" lower_limit="0.14" upper_limit="0.41"/>
                    <measurement group_id="O2" value="0.14" lower_limit="0.04" upper_limit="0.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Right Hand</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.23" lower_limit="0.14" upper_limit="0.41"/>
                    <measurement group_id="O2" value="0.23" lower_limit="0.14" upper_limit="0.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain Pressure Thresholds</title>
        <description>Pressure Algometry (Somedic AB, Sweden) measured pressure/pain thresholds. A hand-held device applied perpendicular to the muscles being tested. Increasing pressure is applied until the participant determines that the sensation has changed from a feeling of pressure to a feeling of pain and force (Kpa) is recorded. When tested at a distant site from the source of pain this test measures central sensitization. Lower pressure values (more sensitive to noxious stimuli) suggest impaired central pain and/or diminished descending inhibition pathway. The left quadriceps muscle was tested as a measure of central sensitization.</description>
        <time_frame>administered on each re-assessment (Visit 1 - pre-chemotherapy, Visit 2 - half-way through chemotherapy, Visit 3 - end of chemotherapy, Visit 4 - 6 months post-chemotherapy) and mixed models accounted for all time points</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Physical Therapy</title>
            <description>4 Physical therapy treatment sessions provided prior to chemotherapy and a home program to continue throughout the trial.&#xD;
Physical Therapy: Physical therapy assessment and treatment for any positive signs of nerve entrapment prior to chemotherapy including nerve gliding exercises, education and splinting. A home program will be provided to continue throughout chemotherapy treatment</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>chemotherapy as usual without physical therapy</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Pressure Thresholds</title>
          <description>Pressure Algometry (Somedic AB, Sweden) measured pressure/pain thresholds. A hand-held device applied perpendicular to the muscles being tested. Increasing pressure is applied until the participant determines that the sensation has changed from a feeling of pressure to a feeling of pain and force (Kpa) is recorded. When tested at a distant site from the source of pain this test measures central sensitization. Lower pressure values (more sensitive to noxious stimuli) suggest impaired central pain and/or diminished descending inhibition pathway. The left quadriceps muscle was tested as a measure of central sensitization.</description>
          <units>kpa</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="923" spread="383"/>
                    <measurement group_id="O2" value="744" spread="285"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Grip Strength</title>
        <description>Hand Dynamometry records grip strength in kgs and was used as a measure of function (3 trials). The dominant hand was tested using the Jamar dynamometer (Patterson medical, USA) in the 2nd handle position. All 48 participants were right handed.</description>
        <time_frame>administered on each re-assessment (Visit 1 - pre-chemotherapy, Visit 2 - half-way through chemotherapy, Visit 3 - end of chemotherapy, Visit 4 - 6 months post-chemotherapy) and mixed models accounted for all time points</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Physical Therapy</title>
            <description>4 Physical therapy treatment sessions provided prior to chemotherapy and a home program to continue throughout the trial.&#xD;
Physical Therapy: Physical therapy assessment and treatment for any positive signs of nerve entrapment prior to chemotherapy including nerve gliding exercises, education and splinting. A home program will be provided to continue throughout chemotherapy treatment</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>chemotherapy as usual without physical therapy</description>
          </group>
        </group_list>
        <measure>
          <title>Grip Strength</title>
          <description>Hand Dynamometry records grip strength in kgs and was used as a measure of function (3 trials). The dominant hand was tested using the Jamar dynamometer (Patterson medical, USA) in the 2nd handle position. All 48 participants were right handed.</description>
          <units>kgs</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.2" spread="5.53"/>
                    <measurement group_id="O2" value="21.8" spread="4.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Post-Hoc</type>
        <title>Vibration Sensory Outcome Stratified by Patient Activity Level</title>
        <description>Measuring Activity Participants were asked about their level of exercise per week at each assessment visit. Participants were considered active if they reported engaging in any form of moderate activity at least 4 times a week (consistent with recommended physical activity guidelines beyond activities of daily living such as walking to the bus or walking the dog around the block) at least 4 times per week on at least 3 out of 4 reassessment visits. Types of reported activities included cycling, running, yoga, swimming, Zumba, dance classes, and tennis. Walking was included if it was at least 30 minutes at a moderate pace. This sub-analysis re-defined the groups as 'active' and 'less active' for the comparison of vibration QST data. This was done to observe the possible impact of exercise on sensory preservation</description>
        <time_frame>administered on each re-assessment (Visit 1 - pre-chemotherapy, Visit 2 - half-way through chemotherapy, Visit 3 - end of chemotherapy, Visit 4 - 6 months post-chemotherapy) and mixed models accounted for all time points</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Active</title>
            <description>Patients that reported being active a least 4 days per week (30 minutes minimum) on 2 or more of the 4 re-assessment visits</description>
          </group>
          <group group_id="O2">
            <title>Less Active</title>
            <description>Any exercise that falls below the cut-off for active</description>
          </group>
        </group_list>
        <measure>
          <title>Vibration Sensory Outcome Stratified by Patient Activity Level</title>
          <description>Measuring Activity Participants were asked about their level of exercise per week at each assessment visit. Participants were considered active if they reported engaging in any form of moderate activity at least 4 times a week (consistent with recommended physical activity guidelines beyond activities of daily living such as walking to the bus or walking the dog around the block) at least 4 times per week on at least 3 out of 4 reassessment visits. Types of reported activities included cycling, running, yoga, swimming, Zumba, dance classes, and tennis. Walking was included if it was at least 30 minutes at a moderate pace. This sub-analysis re-defined the groups as 'active' and 'less active' for the comparison of vibration QST data. This was done to observe the possible impact of exercise on sensory preservation</description>
          <units>micrometers (µm)</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Vibration Left Hand</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.08" lower_limit="0.04" upper_limit="0.14"/>
                    <measurement group_id="O2" value="0.23" lower_limit="0.13" upper_limit="0.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vibration Right Hand</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.14" lower_limit="0.04" upper_limit="0.23"/>
                    <measurement group_id="O2" value="0.24" lower_limit="0.14" upper_limit="0.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Each participant was followed from one week prior to initiation of chemotherapy to 6 months post-chemotherapy. Because of delays, alterations of schedules, patients were followed on average between 8-12 months. Re-assessment data was collected 2 weeks after mid and post chemotherapy visits and the 3 and 6 month visits where scheduled from their last chemotherapy. This is slightly different for each participant due to delays, hospital admissions, etc....</time_frame>
      <desc>Accrual has stopped and all treatment and follow-up has been completed and the study is closed.</desc>
      <group_list>
        <group group_id="E1">
          <title>Physical Therapy</title>
          <description>4 Physical therapy treatment sessions provided prior to chemotherapy and a home program to continue throughout the trial.&#xD;
Physical Therapy: Physical therapy assessment and treatment for any positive signs of nerve entrapment prior to chemotherapy including nerve gliding exercises, education and splinting. A home program will be provided to continue throughout chemotherapy treatment</description>
        </group>
        <group group_id="E2">
          <title>Control</title>
          <description>treatment as usual</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Marshall Pitz</name_or_title>
      <organization>CancerCare Manitoba</organization>
      <phone>2044751431</phone>
      <email>Mpitz@cc.umanitoba.ca</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02239601
org study id: H2014:281
nct id: NCT02239601
lead sponsor: 
collaborator: 
has dmc: No
The cause of Chemotherapy-Induced Peripheral Neuropathy (CIPN) is still unknown. An estimated
      55-60% of patients will experience lasting symptoms affecting function for years
      post-treatment. Physical therapy is an established, effective treatment for entrapped nerves
      and neuropathic pain. This study sought to identify additional risk factors and provide
      evidence for the role of physical therapy in the treatment of CIPN.
A common side effect is chemotherapy induced peripheral neuropathy (CIPN). CIPN is a small
      fibre sensory neuropathy that develops in the hands/feet and worsens with increasing dose and
      duration of treatment. It impacts the Aβ, Aδ, and C-Fiber function involved in light touch
      and vibration sense, thermal detection and thermal pain. This results in a variety of
      positive and/or negative sensory symptoms including hypoesthesia, dysesthesias, hyperalgesia,
      allodynia and neuropathic pain. Quantitative sensory testing (QST) are a variety of
      non-invasive tests aimed at quantifying sensory perceptions used in research to clinically
      assess neuropathy. It is used for sensory detection and pain thresholds for both mechanical
      and thermal stimuli. QST provides information on large myelinated (Aβ), small thinly
      myelinated (Aδ) and unmyelinated (C-fiber) function or dysfunction. Deep pressure threshold
      measured by a pressure algometry stimulates intramuscular afferents, and can be used as a
      measure of central sensitization when used at a distant site from the site of pain. Aδ fibres
      transmit cool detection threshold, while warm detection threshold is transmitted by C-fibers.
      Both noxious heat and noxious cold transmit via C-fiber and Aδ fibers. An increased
      sensitivity to thermal pain thresholds, results in thermal hyperalgesia.

      Physical therapy treatment for nerve disorders is well established in orthopedics and plastic
      surgery for entrapment neuropathies, neuropathic pain, post-operative nerve repair and
      regeneration. Nerve gliding exercises are frequently used exercises in physical therapy to
      improve neural excursion across joints, improve pain and decrease inflammation. Patient
      reported symptoms (patient questionnaires NPRS, S-LANSS and DASH) and quantitative sensory
      testing (QST) specifically pain pressure thresholds and vibration were used for the primary
      purpose in evaluating the role for an upper extremity nerve mobilization physical therapy
      home program during chemotherapy for the prevention and management of CIPN.

      Primary Outcome Measures was the NPRS and reported as those having no vs no pain. Grip
      strength, Vibration, DASH and S-LANSS were identified outcome measures prior to the trial
      that would best describe sensory impairment and function for the physical therapy question

      Additional QST measures collected included warm/cool, Hot/Cold Pain thresholds that were used
      with the vibration data to compare quantitative data on the right and left side to evaluate
      possible a possible dual nerve disorder when combined with surgery as well as identifying
      different sensory profiles of QST data between those reporting neuropathic pain and
      non-neuropathic pain using the S-LANSS

      A sub analysis of data was completed dividing participants that remained active throughout
      compared to less active participants to evaluate the effect of exercise on sensory
      preservation. This was not an intended analysis at the beginning of the trial and these
      participants were not randomized.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Participants With 'Pain' or 'no Pain' as Measured by the Numeric Pain Rating Scale
time frame: Regression models of pain reported over time (mid-docetaxel chemotherapy- 6 months post-chemotherapy). Mid-chemotherapy time frame participants were re-assessed after the 2 round of TC and 4th round of FECD.
description: Numeric Pain Rating Scale - pain rating scale 0-10 (0= no pain to 10= most pain imaginable). Reported as percentages of participants with pain (1-10) vs no pain (0)
measure: Disability of the Arm, Shoulder and Hand (DASH)
time frame: administered on each re-assessment (pre-chemotherapy, mid-way through docetaxel chemotherapy, end of chemotherapy, 6 months post-chemotherapy) and mixed models accounted for all time points
description: A 30 item participant reported questionnaire commonly used to gauge upper limb function. Each item is scored 1-5 with 1 being 'no difficulty' and 5 being 'unable'. Overall score calculated as: [average response (sum of responses divided by number of responses) -1] x 25 to give a score out of 100. Minimum score is 30 with a maximum score of 150. The DASH was chosen because of high test-retest reliability and the responsiveness and construct validity in patients with breast cancer over other quality of life measures. A minimal clinical important difference is a change score of 15. Higher score indicates more impairment to the upper limb
measure: Percentage of Participants With Neuropathic Pain Defined by the Self Report Version of Leeds Assessment for Neuropathic Symptoms and Signs (S-LANSS).
time frame: administered on each re-assessment (Visit 1 - pre-chemotherapy, Visit 2 - half-way through chemotherapy, Visit 3 - end of chemotherapy, Visit 4 - 3 months post-chemotherapy) and mixed models accounted for all time points
description: a 7 item patient reported questionnaire and was used to confirm the presence of neuropathic pain. The score ranges from 0-19 (no symptoms=0, sever symptoms=19) with a score above 12 indicative of neuropathic pain/symptoms. S-LANSS was chosen because of its' specificity and accuracy in a cancer population. Participants were requested to answer specifically for the hands, not feet.
measure: Vibration Sensory Analysis
time frame: administered on each re-assessment (Visit 1 - pre-chemotherapy, Visit 2 - half-way through chemotherapy, Visit 3 - end of chemotherapy, Visit 4 - 6 months post-chemotherapy) and mixed models accounted for all time points
description: Vibration analysis testing for perception thresholds are specific to Aβ nerve fibres. The TSAII Vibration Sensory Analyzer (VSA): Medoc, Israel, was used. The pulp of the index finger lightly touches the sensor that delivers random and varying vibration amplitudes (µm). The participant responds "yes/no" to sensing the vibration. Vibration perception was selected for its sensitivity and has been suggested to be the first clinical sign of CIPN symptoms and was tested bilaterally. Low score indicates better perception while a higher score is poorer sensation. Perception score reported in micrometers (up to 4cm)
measure: Pain Pressure Thresholds
time frame: administered on each re-assessment (Visit 1 - pre-chemotherapy, Visit 2 - half-way through chemotherapy, Visit 3 - end of chemotherapy, Visit 4 - 6 months post-chemotherapy) and mixed models accounted for all time points
description: Pressure Algometry (Somedic AB, Sweden) measured pressure/pain thresholds. A hand-held device applied perpendicular to the muscles being tested. Increasing pressure is applied until the participant determines that the sensation has changed from a feeling of pressure to a feeling of pain and force (Kpa) is recorded. When tested at a distant site from the source of pain this test measures central sensitization. Lower pressure values (more sensitive to noxious stimuli) suggest impaired central pain and/or diminished descending inhibition pathway. The left quadriceps muscle was tested as a measure of central sensitization.
measure: Grip Strength
time frame: administered on each re-assessment (Visit 1 - pre-chemotherapy, Visit 2 - half-way through chemotherapy, Visit 3 - end of chemotherapy, Visit 4 - 6 months post-chemotherapy) and mixed models accounted for all time points
description: Hand Dynamometry records grip strength in kgs and was used as a measure of function (3 trials). The dominant hand was tested using the Jamar dynamometer (Patterson medical, USA) in the 2nd handle position. All 48 participants were right handed.
arm group label: Physical Therapy
arm group type: Experimental
description: 4 Physical therapy treatment sessions provided prior to chemotherapy and a home program to continue throughout the trial.
intervention type: Other
intervention name: Physical Therapy
description: Physical therapy assessment and treatment for any positive signs of nerve entrapment prior to chemotherapy including nerve gliding exercises, education and splinting. A home program was provided and continued throughout chemotherapy treatment
arm group label: Physical Therapy
other name: physiotherapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Barbara L Shay, PhD
role: Study Director
affiliation: University of Manitoba
last name: Elizabeth R Hammond, PhD
role: Principal Investigator
affiliation: University of Manitoba
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: CancerCare Manitoba
investigator full name: Dr. Marshall Pitz
investigator title: Medical Oncologist and Associate Professor , University of Manitoba
mesh term: Peripheral Nervous System Diseases
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 