Clinical trial NCT03290976: Integrative Medicine for Chemotherapy-Induced Peripheral Neuropathy
Official title: Impact of Integrative Medicine on Chemotherapy-Induced Peripheral Neuropathy: A Multi-centered, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chemotherapy-induced Peripheral Neuropathy
Lead sponsor: The Chaim Sheba Medical Center
Sponsor class: OTHER
Collaborators: name: Bnai Zion Medical Center
name: Lin Medical Center, Haifa
name: Carmel Medical Center
First posted: 2017-09-25
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patient-preference, randomized controlled study
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Symptom Severity(neuropathy): Functional Assessment of Cancer Therapy -Taxane (FACT-Tax) tool
timeFrame: Up to 9 weeks
measure: Symptom Severity(neuropathy): European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
timeFrame: Up to 9 weeks
measure: Symptom Severity(neuropathy): Measure Yourself Concerns and Well-being (MYCAW) questionnaire:
timeFrame: Up to 9 weeks
Secondary outcomes:
measure: Symptom Severity(additional concerns): Functional Assessment of Cancer Therapy -Taxane (FACT-Tax) tool
timeFrame: Up to 9 weeks
measure: Symptom Severity(additional concerns): European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
timeFrame: Up to 9 weeks
measure: Symptom Severity(additional concerns): Measure Yourself Concerns and Well-being (MYCAW) questionnaire:
timeFrame: Up to 9 weeks
measure: Symptom Severity(neuropathy): Physiological Assessment of CIPN Severity
timeFrame: Up to 9 weeks
measure: Adherence to Chemotherapy Regimen: Relative Dose Intensity (RDI)
timeFrame: After 9 weeks
measure: Adverse Effects Associated with CIM treatments
timeFrame: After 9 weeks
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Chaim Sheba Medical Center
Study officials:
affiliation: Bnai Zion Medical Center, Haifa
name: Elad Schiff, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lin Medical Center, Haifa
name: Eran Ben-Arye, MD
role: PRINCIPAL_INVESTIGATOR
References: