Status:
COMPLETED
Integrative Medicine for Chemotherapy-Induced Peripheral Neuropathy
Lead Sponsor:
The Chaim Sheba Medical Center
Collaborating Sponsors:
Bnai Zion Medical Center
Lin Medical Center, Haifa
Conditions:
Chemotherapy-induced Peripheral Neuropathy
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- \- 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.
Key Trial Info
Start Date :
March 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2021
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT03290976
Start Date
March 1 2018
End Date
May 31 2021
Last Update
August 22 2024
Active Locations (1)
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1
Chaim Sheba Medical Center
Ramat Gan, Israel, 52621