<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/NCT03290976</url>
  </required_header>
  <id_info>
    <org_study_id>4462-17-SMC</org_study_id>
    <nct_id>NCT03290976</nct_id>
  </id_info>
  <brief_title>Integrative Medicine for Chemotherapy-Induced Peripheral Neuropathy</brief_title>
  <official_title>Impact of Integrative Medicine on Chemotherapy-Induced Peripheral Neuropathy: A Multi-centered, Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Chaim Sheba Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Bnai Zion Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Lin Medical Center, Haifa</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Carmel Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The Chaim Sheba Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Chemotherapy-induced peripheral neuropathy (CIPN) is a common and often debilitating&#xD;
      complication of cancer treatments. There is presently no known treatment which can prevent&#xD;
      the onset of CIPN, with treatment of existing symptoms limited to reducing the dose intensity&#xD;
      of the offending agent. Clinical research has shown that complementary/integrative medicine&#xD;
      (CIM) modalities such as acupuncture and reflexology may be effective in relieving&#xD;
      CIPN-related symptoms. The present study will included 120 patients suffering from&#xD;
      CIPN-related symptoms, and will take place at 3 medical centers in Israel which provide CIM&#xD;
      treatments to oncology and hemato-oncology patients. Participants will be allocated to either&#xD;
      the control arm (standard conventional supportive care; n=40) or to the intervention arm of&#xD;
      the study (standard care with CIM treatments; n=80), based on their preference. Patients in&#xD;
      the treatment arm of the study will be randomly allocated to either twice-weekly, single&#xD;
      modality acupuncture treatments (n=40), or to a multi-modality treatment program (n=40),&#xD;
      which will include acupuncture and additional CIM modalities (i.e., manual-movement and&#xD;
      mind-body therapies), for a 6-week period.&#xD;
&#xD;
      The effect of CIM treatments in reducing the severity of CIPN-related symptoms will be&#xD;
      assessed at baseline and at 6- and 9-week follow-up visits, using the Functional Assessment&#xD;
      of Cancer Therapy -Taxane (FACT-Tax) tool; the European Organization for Research and&#xD;
      Treatment of Cancer Quality of Life Questionnaire - C30 (EORTC QLQ-C30); and the Measure&#xD;
      Yourself Concerns and Well-being (MYCAW) questionnaire. Interim assessment of symptom&#xD;
      severity will be conducted by the study nurse throughout the study period, through either&#xD;
      telephone or e-mail. Additional study outcomes will include the safety of the CIM treatments;&#xD;
      QOL-related concerns which may affect CIPN-related symptoms (e.g., anxiety, depression, sleep&#xD;
      disturbances, etc.), as well as issues related to body image and coping with CIPN;&#xD;
      physiological assessment of CIPN using a von Frey test (with hairs of varying diameters to&#xD;
      assess the threshold for touch evoked sensations); and adherence to the planned oncology&#xD;
      treatment regimen, as measured by the Relative Dose Intensity (RDI) calculation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 1, 2018</start_date>
  <completion_date type="Anticipated">March 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">March 31, 2022</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>
    <intervention_model_description>Patient-preference, randomized controlled study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Symptom Severity(neuropathy): Functional Assessment of Cancer Therapy -Taxane (FACT-Tax) tool</measure>
    <time_frame>Up to 9 weeks</time_frame>
    <description>CIPN-related symptoms</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Symptom Severity(neuropathy): European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)</measure>
    <time_frame>Up to 9 weeks</time_frame>
    <description>CIPN-related symptoms</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Symptom Severity(neuropathy): Measure Yourself Concerns and Well-being (MYCAW) questionnaire:</measure>
    <time_frame>Up to 9 weeks</time_frame>
    <description>CIPN-related symptoms</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Symptom Severity(additional concerns): Functional Assessment of Cancer Therapy -Taxane (FACT-Tax) tool</measure>
    <time_frame>Up to 9 weeks</time_frame>
    <description>Additional QOL-related concerns</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptom Severity(additional concerns): European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)</measure>
    <time_frame>Up to 9 weeks</time_frame>
    <description>Additional QOL-related concerns</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptom Severity(additional concerns): Measure Yourself Concerns and Well-being (MYCAW) questionnaire:</measure>
    <time_frame>Up to 9 weeks</time_frame>
    <description>Additional QOL-related concerns</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptom Severity(neuropathy): Physiological Assessment of CIPN Severity</measure>
    <time_frame>Up to 9 weeks</time_frame>
    <description>The von Frey test (Semmes Weinstein Monofilament Set, Bioseb In Vivo Research Instruments, France/USA).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence to Chemotherapy Regimen: Relative Dose Intensity (RDI)</measure>
    <time_frame>After 9 weeks</time_frame>
    <description>RDI = Dose Administered (mg) / Interval between treatments (days) ÷ Planned Dose (mg) / Planned Interval between treatments (days)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Effects Associated with CIM treatments</measure>
    <time_frame>After 9 weeks</time_frame>
    <description>Registering of any adverse events believed to be related to the study intervention treatments</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Chemotherapy-induced Peripheral Neuropathy</condition>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control group will consist of patients who choose not to undergo CIM treatments for their CIPN-related symptoms. Participants in this arm of the study will receive standard conventional supportive care, as provided by their oncology health care professionals (HCPs), and closely monitored for any changes in the severity of their CIPN-related symptoms.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention Group A: Single Modality (acupuncture)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients choosing to undergo CIM treatments, in addition to standard conventional care: Acupuncture x2/week, for 6 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention Group B: Multi-modality (acupuncture &quot;plus&quot;)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients choosing to undergo CIM treatments, in addition to standard conventional care: Acupuncture with additional CIM treatment modalities, x2/week, for 6 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Acupuncture</intervention_name>
    <description>Acupuncture treatments will be patient-tailored, with the acupuncture points (acu-points) to be selected by the acupuncturist at each treatment session, in accordance with the dynamic of the patient's symptoms, concerns and expectations. At the same time, acupuncturists will be required to choose at least 5 of the following 11 acupoints, which are to be incorporated into their treatment regimen:&#xD;
Lower limb points: Liver (LIV) 3, Spleen (SP) 4, SP6, Stomach (ST) 36, Gallbladder (GB) 34, Kidney (KID) 3, LIV8, Web (Bafeng) points Upper limb points: Large Intestine (LI) 4, LI 11, LI10, Pericardium (PC) 6, Triple Warmer (TW) 3/4/5</description>
    <arm_group_label>Intervention Group A: Single Modality (acupuncture)</arm_group_label>
    <arm_group_label>Intervention Group B: Multi-modality (acupuncture &quot;plus&quot;)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Multi-modality (Acupuncture &quot;plus&quot;)</intervention_name>
    <description>A number of additional CIM treatment modalities will be added to the acupuncture treatment in this arm of the study, in accordance with the practitioners available at each of the participating study centers. These will include one of more of the following:&#xD;
Manual-movement therapies - e.g. acupressure/reflexology, self- and caregiver-practiced acupressure&#xD;
Mind-body therapies - e.g. relaxation/imagery method, Anthroposophic music therapy The multimodal CIM treatment regimen will be re-evaluated at each session, and adapted according to the concerns and expectations of the patients, as well as the recommendation of the treating CIM practitioner.</description>
    <arm_group_label>Intervention Group B: Multi-modality (acupuncture &quot;plus&quot;)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female patients with breast or gynecological cancers who are undergoing a treatment&#xD;
             regimen which includes taxane-based chemotherapy (e.g., Paclitaxel, Docetaxel); or&#xD;
&#xD;
          -  Patients of either gender with hematological malignancies who are undergoing a&#xD;
             treatment regimen which includes neuropathy-inducing agents (e.g., bortezumab for&#xD;
             multiple myeloma, etc.).&#xD;
&#xD;
          -  Eligible patients will report altered sensations and/or pain in the areas of the feet&#xD;
             and or hands, with a score of ≥ 2 (moderate-to-severe) for chemotherapy-induced&#xD;
             peripheral neuropathy on the National Cancer Institute (NCI) Common Toxicity Criteria&#xD;
             for Adverse Events - version 4.0 (CTC-AE.v-4.0)&#xD;
&#xD;
          -  The onset of CIPN-related symptoms must be recent, following a recently-administered&#xD;
             course of chemotherapy and with symptoms appearing no more than a month prior to study&#xD;
             recruitment.&#xD;
&#xD;
        Patients must be able to comply with the study protocol, which includes weekly follow-up&#xD;
        visits, either in person or by phone; completion of the study questionnaires, in accordance&#xD;
        with the study protocol; and, for patients in the treatment arm of the study, attending&#xD;
        twice-weekly CIM treatment sessions.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Patients not fulfilling the inclusion criteria, or those with a history of chronic&#xD;
        medical conditions which predispose to the development of CIPN (e.g., diabetes mellitus,&#xD;
        alcohol abuse), will be ineligible for participation in the study.&#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>Elad Schiff, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bnai Zion Medical Center, Haifa</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Eran Ben-Arye, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lin Medical Center, Haifa</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Noah Samuels, MD</last_name>
    <phone>972-3-5307327</phone>
    <email>noah.samuels@sheba.health.gov.il</email>
  </overall_contact>
  <location>
    <facility>
      <name>Chaim Sheba Medical Center</name>
      <address>
        <city>Ramat Gan</city>
        <zip>52621</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Noah Samuels, MD</last_name>
      <phone>972-3-5307327</phone>
      <email>noah.samuels@sheba.health.gov.il</email>
    </contact>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>September 13, 2017</study_first_submitted>
  <study_first_submitted_qc>September 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>August 2, 2021</last_update_submitted>
  <last_update_submitted_qc>August 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Chaim Sheba Medical Center</investigator_affiliation>
    <investigator_full_name>Noah Samuels</investigator_full_name>
    <investigator_title>Medical Director, Tal Center for Integrative Oncology, Institute of Oncology</investigator_title>
  </responsible_party>
  <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>
  <!-- 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/NCT03290976
org study id: 4462-17-SMC
nct id: NCT03290976
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Chemotherapy-induced peripheral neuropathy (CIPN) is a common and often debilitating
      complication of cancer treatments. There is presently no known treatment which can prevent
      the onset of CIPN, with treatment of existing symptoms limited to reducing the dose intensity
      of the offending agent. Clinical research has shown that complementary/integrative medicine
      (CIM) modalities such as acupuncture and reflexology may be effective in relieving
      CIPN-related symptoms. The present study will included 120 patients suffering from
      CIPN-related symptoms, and will take place at 3 medical centers in Israel which provide CIM
      treatments to oncology and hemato-oncology patients. Participants will be allocated to either
      the control arm (standard conventional supportive care; n=40) or to the intervention arm of
      the study (standard care with CIM treatments; n=80), based on their preference. Patients in
      the treatment arm of the study will be randomly allocated to either twice-weekly, single
      modality acupuncture treatments (n=40), or to a multi-modality treatment program (n=40),
      which will include acupuncture and additional CIM modalities (i.e., manual-movement and
      mind-body therapies), for a 6-week period.

      The effect of CIM treatments in reducing the severity of CIPN-related symptoms will be
      assessed at baseline and at 6- and 9-week follow-up visits, using the Functional Assessment
      of Cancer Therapy -Taxane (FACT-Tax) tool; the European Organization for Research and
      Treatment of Cancer Quality of Life Questionnaire - C30 (EORTC QLQ-C30); and the Measure
      Yourself Concerns and Well-being (MYCAW) questionnaire. Interim assessment of symptom
      severity will be conducted by the study nurse throughout the study period, through either
      telephone or e-mail. Additional study outcomes will include the safety of the CIM treatments;
      QOL-related concerns which may affect CIPN-related symptoms (e.g., anxiety, depression, sleep
      disturbances, etc.), as well as issues related to body image and coping with CIPN;
      physiological assessment of CIPN using a von Frey test (with hairs of varying diameters to
      assess the threshold for touch evoked sensations); and adherence to the planned oncology
      treatment regimen, as measured by the Relative Dose Intensity (RDI) calculation.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patient-preference, randomized controlled study
primary purpose: Treatment
masking: None (Open Label)
measure: Symptom Severity(neuropathy): Functional Assessment of Cancer Therapy -Taxane (FACT-Tax) tool
time frame: Up to 9 weeks
description: CIPN-related symptoms
measure: Symptom Severity(neuropathy): European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
time frame: Up to 9 weeks
description: CIPN-related symptoms
measure: Symptom Severity(neuropathy): Measure Yourself Concerns and Well-being (MYCAW) questionnaire:
time frame: Up to 9 weeks
description: CIPN-related symptoms
measure: Symptom Severity(additional concerns): Functional Assessment of Cancer Therapy -Taxane (FACT-Tax) tool
time frame: Up to 9 weeks
description: Additional QOL-related concerns
measure: Symptom Severity(additional concerns): European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
time frame: Up to 9 weeks
description: Additional QOL-related concerns
measure: Symptom Severity(additional concerns): Measure Yourself Concerns and Well-being (MYCAW) questionnaire:
time frame: Up to 9 weeks
description: Additional QOL-related concerns
measure: Symptom Severity(neuropathy): Physiological Assessment of CIPN Severity
time frame: Up to 9 weeks
description: The von Frey test (Semmes Weinstein Monofilament Set, Bioseb In Vivo Research Instruments, France/USA).
measure: Adherence to Chemotherapy Regimen: Relative Dose Intensity (RDI)
time frame: After 9 weeks
description: RDI = Dose Administered (mg) / Interval between treatments (days) ÷ Planned Dose (mg) / Planned Interval between treatments (days)
measure: Adverse Effects Associated with CIM treatments
time frame: After 9 weeks
description: Registering of any adverse events believed to be related to the study intervention treatments
arm group label: Control Group
arm group type: No Intervention
description: The control group will consist of patients who choose not to undergo CIM treatments for their CIPN-related symptoms. Participants in this arm of the study will receive standard conventional supportive care, as provided by their oncology health care professionals (HCPs), and closely monitored for any changes in the severity of their CIPN-related symptoms.
arm group label: Intervention Group A: Single Modality (acupuncture)
arm group type: Active Comparator
description: Patients choosing to undergo CIM treatments, in addition to standard conventional care: Acupuncture x2/week, for 6 weeks.
arm group label: Intervention Group B: Multi-modality (acupuncture "plus")
arm group type: Active Comparator
description: Patients choosing to undergo CIM treatments, in addition to standard conventional care: Acupuncture with additional CIM treatment modalities, x2/week, for 6 weeks.
intervention type: Other
intervention name: Acupuncture
description: Acupuncture treatments will be patient-tailored, with the acupuncture points (acu-points) to be selected by the acupuncturist at each treatment session, in accordance with the dynamic of the patient's symptoms, concerns and expectations. At the same time, acupuncturists will be required to choose at least 5 of the following 11 acupoints, which are to be incorporated into their treatment regimen:
Lower limb points: Liver (LIV) 3, Spleen (SP) 4, SP6, Stomach (ST) 36, Gallbladder (GB) 34, Kidney (KID) 3, LIV8, Web (Bafeng) points Upper limb points: Large Intestine (LI) 4, LI 11, LI10, Pericardium (PC) 6, Triple Warmer (TW) 3/4/5
arm group label: Intervention Group A: Single Modality (acupuncture)
arm group label: Intervention Group B: Multi-modality (acupuncture "plus")
intervention type: Other
intervention name: Multi-modality (Acupuncture "plus")
description: A number of additional CIM treatment modalities will be added to the acupuncture treatment in this arm of the study, in accordance with the practitioners available at each of the participating study centers. These will include one of more of the following:
Manual-movement therapies - e.g. acupressure/reflexology, self- and caregiver-practiced acupressure
Mind-body therapies - e.g. relaxation/imagery method, Anthroposophic music therapy The multimodal CIM treatment regimen will be re-evaluated at each session, and adapted according to the concerns and expectations of the patients, as well as the recommendation of the treating CIM practitioner.
arm group label: Intervention Group B: Multi-modality (acupuncture "plus")
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Elad Schiff, MD
role: Principal Investigator
affiliation: Bnai Zion Medical Center, Haifa
last name: Eran Ben-Arye, MD
role: Principal Investigator
affiliation: Lin Medical Center, Haifa
last name: Noah Samuels, MD
phone: 972-3-5307327
email: noah.samuels@sheba.health.gov.il
facility: 
status: Recruiting
contact: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: The Chaim Sheba Medical Center
investigator full name: Noah Samuels
investigator title: Medical Director, Tal Center for Integrative Oncology, Institute of Oncology
mesh term: Peripheral Nervous System Diseases
sharing ipd: No