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Integrative Medicine for Chemotherapy-Induced Peripheral Neuropathy

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ClinicalTrials.gov Identifier: NCT03290976
Recruitment Status : Recruiting
First Posted : September 25, 2017
Last Update Posted : March 6, 2018
Sponsor:
Collaborators:
Bnai Zion Medical Center
Lin Medical Center, Haifa
Carmel Medical Center
Information provided by (Responsible Party):
Noah Samuels, The Chaim Sheba Medical Center

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Chemotherapy-induced Peripheral Neuropathy Other: Acupuncture Other: Multi-modality (Acupuncture "plus") Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patient-preference, randomized controlled study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Integrative Medicine on Chemotherapy-Induced Peripheral Neuropathy: A Multi-centered, Randomized Controlled Trial
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : October 31, 2018
Estimated Study Completion Date : October 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control Group
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.
Active Comparator: Intervention Group A: Single Modality (acupuncture)
Patients choosing to undergo CIM treatments, in addition to standard conventional care: Acupuncture x2/week, for 6 weeks.
Other: Acupuncture

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


Active Comparator: Intervention Group B: Multi-modality (acupuncture "plus")
Patients choosing to undergo CIM treatments, in addition to standard conventional care: Acupuncture with additional CIM treatment modalities, x2/week, for 6 weeks.
Other: Acupuncture

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


Other: Multi-modality (Acupuncture "plus")

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.




Primary Outcome Measures :
  1. Symptom Severity(neuropathy): Functional Assessment of Cancer Therapy -Taxane (FACT-Tax) tool [ Time Frame: Up to 9 weeks ]
    CIPN-related symptoms

  2. Symptom Severity(neuropathy): European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) [ Time Frame: Up to 9 weeks ]
    CIPN-related symptoms

  3. Symptom Severity(neuropathy): Measure Yourself Concerns and Well-being (MYCAW) questionnaire: [ Time Frame: Up to 9 weeks ]
    CIPN-related symptoms


Secondary Outcome Measures :
  1. Symptom Severity(additional concerns): Functional Assessment of Cancer Therapy -Taxane (FACT-Tax) tool [ Time Frame: Up to 9 weeks ]
    Additional QOL-related concerns

  2. 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 ]
    Additional QOL-related concerns

  3. Symptom Severity(additional concerns): Measure Yourself Concerns and Well-being (MYCAW) questionnaire: [ Time Frame: Up to 9 weeks ]
    Additional QOL-related concerns

  4. Symptom Severity(neuropathy): Physiological Assessment of CIPN Severity [ Time Frame: Up to 9 weeks ]
    The von Frey test (Semmes Weinstein Monofilament Set, Bioseb In Vivo Research Instruments, France/USA).

  5. Adherence to Chemotherapy Regimen: Relative Dose Intensity (RDI) [ Time Frame: After 9 weeks ]
    RDI = Dose Administered (mg) / Interval between treatments (days) ÷ Planned Dose (mg) / Planned Interval between treatments (days)

  6. Adverse Effects Associated with CIM treatments [ Time Frame: After 9 weeks ]
    Registering of any adverse events believed to be related to the study intervention treatments



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female patients with breast or gynecological cancers who are undergoing a treatment regimen which includes taxane-based chemotherapy (e.g., Paclitaxel, Docetaxel); or
  • Patients of either gender with hematological malignancies who are undergoing a treatment regimen which includes neuropathy-inducing agents (e.g., bortezumab for multiple myeloma, etc.).
  • Eligible patients will report altered sensations and/or pain in the areas of the feet and or hands, with a score of ≥ 2 (moderate-to-severe) for chemotherapy-induced peripheral neuropathy on the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events - version 4.0 (CTC-AE.v-4.0)
  • The onset of CIPN-related symptoms must be recent, following a recently-administered course of chemotherapy and with symptoms appearing no more than a month prior to study recruitment.

Patients must be able to comply with the study protocol, which includes weekly follow-up visits, either in person or by phone; completion of the study questionnaires, in accordance with the study protocol; and, for patients in the treatment arm of the study, attending twice-weekly CIM treatment sessions.

Exclusion Criteria:

- Patients not fulfilling the inclusion criteria, or those with a history of chronic medical conditions which predispose to the development of CIPN (e.g., diabetes mellitus, alcohol abuse), will be ineligible for participation in the study.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03290976


Contacts
Contact: Noah Samuels, MD 972-3-5307327 noah.samuels@sheba.health.gov.il

Locations
Israel
Chaim Sheba Medical Center Recruiting
Ramat Gan, Israel, 52621
Contact: Noah Samuels, MD    972-3-5307327    noah.samuels@sheba.health.gov.il   
Sponsors and Collaborators
The Chaim Sheba Medical Center
Bnai Zion Medical Center
Lin Medical Center, Haifa
Carmel Medical Center
Investigators
Principal Investigator: Elad Schiff, MD Bnai Zion Medical Center, Haifa
Principal Investigator: Eran Ben-Arye, MD Lin Medical Center, Haifa

Responsible Party: Noah Samuels, Medical Director, Tal Center for Integrative Oncology, Institute of Oncology, The Chaim Sheba Medical Center
ClinicalTrials.gov Identifier: NCT03290976     History of Changes
Other Study ID Numbers: 4462-17-SMC
First Posted: September 25, 2017    Key Record Dates
Last Update Posted: March 6, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases