<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/NCT02221700</url>
  </required_header>
  <id_info>
    <org_study_id>2014-0250</org_study_id>
    <secondary_id>NCI-2015-00386</secondary_id>
    <secondary_id>2014-0250</secondary_id>
    <nct_id>NCT02221700</nct_id>
  </id_info>
  <brief_title>Massage Therapy in Reducing Chemotherapy-Induced Peripheral Neuropathy in Patients With Gastrointestinal or Breast Malignancies</brief_title>
  <official_title>A Pilot Study of Massage for Symptom Reduction in Chemotherapy-Induced Peripheral Neuropathy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>M.D. Anderson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>M.D. Anderson Cancer Center</source>
  <brief_summary>
    <textblock>
      This clinical trial studies massage therapy in reducing chemotherapy-induced nerve problems&#xD;
      (peripheral neuropathy) that may cause pain, numbness, tingling, swelling, or muscle weakness&#xD;
      in different parts of the body in patients with gastrointestinal or breast malignancies.&#xD;
      Massage therapy may help reduce chemotherapy-induced peripheral neuropathy symptoms and&#xD;
      improve quality of life.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES; I. To compare completion rates of two massage treatment protocols&#xD;
      (twice-weekly for 6 weeks versus three times weekly for 4 weeks) for patients with chronic,&#xD;
      chemotherapy-induced peripheral neuropathy.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To determine the initial efficacy and effect size estimates of twice versus three times&#xD;
      weekly site specific (lower extremity) massage versus alternate massage site&#xD;
      (head/neck/shoulder) control groups at treating chronic, lower extremity chemotherapy-induced&#xD;
      peripheral neuropathy.&#xD;
&#xD;
      II. To determine the initial efficacy and effect size estimates of massage on patient quality&#xD;
      of life and functional performance tests.&#xD;
&#xD;
      OUTLINE: Patients are randomized to 1 of 4 groups.&#xD;
&#xD;
      GROUP I: Patients undergo massage therapy over 30 minutes to the affected legs at the foot&#xD;
      and toes, ending at the knee, thrice weekly for 4 weeks.&#xD;
&#xD;
      GROUP II: Patients undergo massage therapy over 30 minutes to the affected legs at the foot&#xD;
      and toes, ending at the knee, twice weekly for 6 weeks.&#xD;
&#xD;
      GROUP III: Patients undergo massage therapy over 30 minutes to the head, neck, and shoulder&#xD;
      thrice weekly for 4 weeks.&#xD;
&#xD;
      GROUP IV: Patients undergo massage therapy over 30 minutes to the head, neck, and shoulder&#xD;
      twice weekly for 6 weeks.&#xD;
&#xD;
      After completion of study, patients are followed periodically.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">April 9, 2015</start_date>
  <completion_date type="Anticipated">April 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">April 30, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Completion Rates of Two Massage Treatment Protocols for Patients With Chronic, Oxaliplatin-Induced Peripheral Neuropathy</measure>
    <time_frame>10 weeks</time_frame>
    <description>Completion rate defined as the average number of treatments completed of a possible 12 for patients in each protocol. Mean and standard deviation, along with a 95% confidence interval (CI) of the mean of the number of massages completed for each of the two massage schedules computed. Two-sample t-test used to compare the number of massages completed between the two schedules using a two-sided 0.05 significance level.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality and intensity of neuropathic pain</measure>
    <time_frame>At 10 weeks</time_frame>
    <description>Will be measured by Pain Quality Assessment Scale (PQAS). To estimate the efficacy of the massage treatments at 10 weeks, linear regression will be used with PQAS as the dependent variable, massage site and schedule being two binary independent variables with interaction, adjusting for appropriate covariates such as the baseline value of PQAS. To assess the efficacy of the massage treatments over time linear mixed models (LMMs) will be used.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life (QOL)</measure>
    <time_frame>Up to 10 weeks</time_frame>
    <description>Will be measured by the Medical Outcomes Study Short Form 36. Pairwise comparisons between arms will be made as desirable, adjusting for multiple comparisons using the Bonferroni approach. Similar linear regression and LMM analyses will be carried out for the QOL and function measures.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Function and balance</measure>
    <time_frame>Up to 10 weeks</time_frame>
    <description>Will be measured by the Timed Up and Go test, the Single Limb Stance, and the Activities-Specific Balance Confidence Scale. Pairwise comparisons between arms will be made as desirable, adjusting for multiple comparisons using the Bonferroni approach. Similar linear regression and LMM analyses will be carried out for the QOL and function measures.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptoms associated specifically with chemotherapy-induced peripheral neuropathy</measure>
    <time_frame>Up to 10 weeks</time_frame>
    <description>Will be assessed using the Functional Assessment of Cancer Therapy/Gynecological Oncology Group-neurotoxicity version 4 questionnaire. Pairwise comparisons between arms will be made as desirable, adjusting for multiple comparisons using the Bonferroni approach. Similar linear regression and LMM analyses will be carried out for the QOL and function measures.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Baseline treatment expectations</measure>
    <time_frame>Baseline</time_frame>
    <description>Baseline treatment expectations will be assessed as a predictor of the secondary measures at week 10.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Malignant Breast Neoplasm</condition>
  <condition>Malignant Digestive System Neoplasm</condition>
  <condition>Peripheral Neuropathy</condition>
  <arm_group>
    <arm_group_label>Group I (leg massage 3 x weekly for 4 weeks)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergo massage therapy over 30 minutes to the affected legs at the foot and toes, ending at the knee, thrice weekly for 4 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group II (leg massage 2 x weekly for 6 weeks)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergo massage therapy over 30 minutes to the affected legs at the foot and toes, ending at the knee, twice weekly for 6 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group III (head/neck/shoulder massage 3 x weekly for 4 weeks)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergo massage therapy over 30 minutes to the head, neck, and shoulder thrice weekly for 4 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group IV (head/neck/shoulder massage 2 x weekly for 6 weeks)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergo massage therapy over 30 minutes to the head, neck, and shoulder twice weekly for 6 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Massage Therapy</intervention_name>
    <description>Undergo massage therapy</description>
    <arm_group_label>Group I (leg massage 3 x weekly for 4 weeks)</arm_group_label>
    <arm_group_label>Group II (leg massage 2 x weekly for 6 weeks)</arm_group_label>
    <arm_group_label>Group III (head/neck/shoulder massage 3 x weekly for 4 weeks)</arm_group_label>
    <arm_group_label>Group IV (head/neck/shoulder massage 2 x weekly for 6 weeks)</arm_group_label>
    <other_name>Massage</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Quality-of-Life Assessment</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Group I (leg massage 3 x weekly for 4 weeks)</arm_group_label>
    <arm_group_label>Group II (leg massage 2 x weekly for 6 weeks)</arm_group_label>
    <arm_group_label>Group III (head/neck/shoulder massage 3 x weekly for 4 weeks)</arm_group_label>
    <arm_group_label>Group IV (head/neck/shoulder massage 2 x weekly for 6 weeks)</arm_group_label>
    <other_name>Quality of Life Assessment</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire Administration</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Group I (leg massage 3 x weekly for 4 weeks)</arm_group_label>
    <arm_group_label>Group II (leg massage 2 x weekly for 6 weeks)</arm_group_label>
    <arm_group_label>Group III (head/neck/shoulder massage 3 x weekly for 4 weeks)</arm_group_label>
    <arm_group_label>Group IV (head/neck/shoulder massage 2 x weekly for 6 weeks)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All gastrointestinal malignancies where the patient received oxaliplatin for cancer&#xD;
             treatment or breast malignancies where patients have received docetaxel or paclitaxel&#xD;
             for cancer treatment&#xD;
&#xD;
          -  Greater or equal to 6 months from last chemotherapy treatment&#xD;
&#xD;
          -  Must understand and read English, sign a written informed consent, and follow protocol&#xD;
             requirements&#xD;
&#xD;
          -  Must be willing to come to MD Anderson Main Campus (Texas Medical Center) for&#xD;
             intervention&#xD;
&#xD;
          -  Lower extremity neuropathy per patient report attributable to oxaliplatin, docetaxel&#xD;
             or paclitaxel (neurotoxic chemotherapeutic agent) as determined by patient history of&#xD;
             neurotoxic agent administration and no history of other attributable causes such as&#xD;
             diabetic neuropathy&#xD;
&#xD;
          -  Patient self-report neuropathy score greater than or equal to 3 on a 0 to 10 numeric&#xD;
             scale and/or grade 2 or 3 neuropathy (according to the National Cancer Institute&#xD;
             Common Toxicity Criteria 4 point grading scale)&#xD;
&#xD;
          -  Within 2 weeks prior to study enrollment the patient must be on a stable dose of&#xD;
             medications for management of chemotherapy-induced peripheral neuropathy (CIPN)&#xD;
             symptoms; for at least 2 weeks prior to enrollment stable dose is defined as:&#xD;
&#xD;
               -  No change in drug class&#xD;
&#xD;
               -  Increases or decreases that are less than or equal to 20% of the total dosage;&#xD;
                  all drug classes are allowed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with previously diagnosed peripheral neuropathy pre-dating their neurotoxic&#xD;
             chemotherapy administration or from causes other than chemotherapy&#xD;
&#xD;
          -  Platelets less than 50,000 within 6 months prior to study enrollment or&#xD;
&#xD;
          -  Neutrophil count less than 500 within 6 months prior to study enrollment&#xD;
&#xD;
          -  Deep venous thrombosis (DVT) diagnosed within 12 months of study enrollment or history&#xD;
             or untreated lower extremity DVT, bone metastases, currently active skin infection, or&#xD;
             lymphedema currently involving the treatment field&#xD;
&#xD;
          -  Women who are pregnant at time of enrollment; pregnancy will be assessed at enrollment&#xD;
             using urine pregnancy test&#xD;
&#xD;
          -  Diagnosis of diabetes&#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>Gabriel Lopez</last_name>
    <role>Principal Investigator</role>
    <affiliation>M.D. Anderson Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>M D Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mdanderson.org</url>
    <description>University of Texas MD Anderson Cancer Center Website</description>
  </link>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>August 19, 2014</study_first_submitted>
  <study_first_submitted_qc>August 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2014</study_first_posted>
  <last_update_submitted>February 10, 2022</last_update_submitted>
  <last_update_submitted_qc>February 10, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Digestive System Neoplasms</mesh_term>
    <mesh_term>Gastrointestinal Neoplasms</mesh_term>
    <mesh_term>Peripheral Nervous System Diseases</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02221700
org study id: 2014-0250
secondary id: NCI-2015-00386
secondary id: 2014-0250
nct id: NCT02221700
lead sponsor: 
collaborator: 
This clinical trial studies massage therapy in reducing chemotherapy-induced nerve problems
      (peripheral neuropathy) that may cause pain, numbness, tingling, swelling, or muscle weakness
      in different parts of the body in patients with gastrointestinal or breast malignancies.
      Massage therapy may help reduce chemotherapy-induced peripheral neuropathy symptoms and
      improve quality of life.
PRIMARY OBJECTIVES; I. To compare completion rates of two massage treatment protocols
      (twice-weekly for 6 weeks versus three times weekly for 4 weeks) for patients with chronic,
      chemotherapy-induced peripheral neuropathy.

      SECONDARY OBJECTIVES:

      I. To determine the initial efficacy and effect size estimates of twice versus three times
      weekly site specific (lower extremity) massage versus alternate massage site
      (head/neck/shoulder) control groups at treating chronic, lower extremity chemotherapy-induced
      peripheral neuropathy.

      II. To determine the initial efficacy and effect size estimates of massage on patient quality
      of life and functional performance tests.

      OUTLINE: Patients are randomized to 1 of 4 groups.

      GROUP I: Patients undergo massage therapy over 30 minutes to the affected legs at the foot
      and toes, ending at the knee, thrice weekly for 4 weeks.

      GROUP II: Patients undergo massage therapy over 30 minutes to the affected legs at the foot
      and toes, ending at the knee, twice weekly for 6 weeks.

      GROUP III: Patients undergo massage therapy over 30 minutes to the head, neck, and shoulder
      thrice weekly for 4 weeks.

      GROUP IV: Patients undergo massage therapy over 30 minutes to the head, neck, and shoulder
      twice weekly for 6 weeks.

      After completion of study, patients are followed periodically.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Investigator)
measure: Completion Rates of Two Massage Treatment Protocols for Patients With Chronic, Oxaliplatin-Induced Peripheral Neuropathy
time frame: 10 weeks
description: Completion rate defined as the average number of treatments completed of a possible 12 for patients in each protocol. Mean and standard deviation, along with a 95% confidence interval (CI) of the mean of the number of massages completed for each of the two massage schedules computed. Two-sample t-test used to compare the number of massages completed between the two schedules using a two-sided 0.05 significance level.
measure: Quality and intensity of neuropathic pain
time frame: At 10 weeks
description: Will be measured by Pain Quality Assessment Scale (PQAS). To estimate the efficacy of the massage treatments at 10 weeks, linear regression will be used with PQAS as the dependent variable, massage site and schedule being two binary independent variables with interaction, adjusting for appropriate covariates such as the baseline value of PQAS. To assess the efficacy of the massage treatments over time linear mixed models (LMMs) will be used.
measure: Quality of life (QOL)
time frame: Up to 10 weeks
description: Will be measured by the Medical Outcomes Study Short Form 36. Pairwise comparisons between arms will be made as desirable, adjusting for multiple comparisons using the Bonferroni approach. Similar linear regression and LMM analyses will be carried out for the QOL and function measures.
measure: Function and balance
time frame: Up to 10 weeks
description: Will be measured by the Timed Up and Go test, the Single Limb Stance, and the Activities-Specific Balance Confidence Scale. Pairwise comparisons between arms will be made as desirable, adjusting for multiple comparisons using the Bonferroni approach. Similar linear regression and LMM analyses will be carried out for the QOL and function measures.
measure: Symptoms associated specifically with chemotherapy-induced peripheral neuropathy
time frame: Up to 10 weeks
description: Will be assessed using the Functional Assessment of Cancer Therapy/Gynecological Oncology Group-neurotoxicity version 4 questionnaire. Pairwise comparisons between arms will be made as desirable, adjusting for multiple comparisons using the Bonferroni approach. Similar linear regression and LMM analyses will be carried out for the QOL and function measures.
measure: Baseline treatment expectations
time frame: Baseline
description: Baseline treatment expectations will be assessed as a predictor of the secondary measures at week 10.
arm group label: Group I (leg massage 3 x weekly for 4 weeks)
arm group type: Experimental
description: Patients undergo massage therapy over 30 minutes to the affected legs at the foot and toes, ending at the knee, thrice weekly for 4 weeks.
arm group label: Group II (leg massage 2 x weekly for 6 weeks)
arm group type: Experimental
description: Patients undergo massage therapy over 30 minutes to the affected legs at the foot and toes, ending at the knee, twice weekly for 6 weeks.
arm group label: Group III (head/neck/shoulder massage 3 x weekly for 4 weeks)
arm group type: Experimental
description: Patients undergo massage therapy over 30 minutes to the head, neck, and shoulder thrice weekly for 4 weeks.
arm group label: Group IV (head/neck/shoulder massage 2 x weekly for 6 weeks)
arm group type: Experimental
description: Patients undergo massage therapy over 30 minutes to the head, neck, and shoulder twice weekly for 6 weeks.
intervention type: Procedure
intervention name: Massage Therapy
description: Undergo massage therapy
arm group label: Group I (leg massage 3 x weekly for 4 weeks)
arm group label: Group II (leg massage 2 x weekly for 6 weeks)
arm group label: Group III (head/neck/shoulder massage 3 x weekly for 4 weeks)
arm group label: Group IV (head/neck/shoulder massage 2 x weekly for 6 weeks)
other name: Massage
intervention type: Other
intervention name: Quality-of-Life Assessment
description: Ancillary studies
arm group label: Group I (leg massage 3 x weekly for 4 weeks)
arm group label: Group II (leg massage 2 x weekly for 6 weeks)
arm group label: Group III (head/neck/shoulder massage 3 x weekly for 4 weeks)
arm group label: Group IV (head/neck/shoulder massage 2 x weekly for 6 weeks)
other name: Quality of Life Assessment
intervention type: Other
intervention name: Questionnaire Administration
description: Ancillary studies
arm group label: Group I (leg massage 3 x weekly for 4 weeks)
arm group label: Group II (leg massage 2 x weekly for 6 weeks)
arm group label: Group III (head/neck/shoulder massage 3 x weekly for 4 weeks)
arm group label: Group IV (head/neck/shoulder massage 2 x weekly for 6 weeks)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gabriel Lopez
role: Principal Investigator
affiliation: M.D. Anderson Cancer Center
facility: 
country: United States
url: http://www.mdanderson.org
description: University of Texas MD Anderson Cancer Center Website
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Breast Neoplasms
mesh term: Digestive System Neoplasms
mesh term: Gastrointestinal Neoplasms
mesh term: Peripheral Nervous System Diseases