Ignite Creation Date:
2024-05-06 @ 10:34 AM
Last Modification Date:
2024-10-26 @ 12:32 PM
Study NCT ID:
NCT03290976
Status:
COMPLETED
Last Update Posted:
2021-08-03
First Post:
2017-09-13
Brief Title:
Integrative Medicine for Chemotherapy-Induced Peripheral Neuropathy
Sponsor:
The Chaim Sheba Medical Center
Organization:
The Chaim Sheba Medical Center
Study Overview
Official Title:
Impact of Integrative Medicine on Chemotherapy-Induced Peripheral Neuropathy A Multi-centered Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 complementaryintegrative 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 n40 or to the intervention arm of the study standard care with CIM treatments n80 based on their preference Patients in the treatment arm of the study will be randomly allocated to either twice-weekly single modality acupuncture treatments n40 or to a multi-modality treatment program n40 which will include acupuncture and additional CIM modalities ie 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 eg 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
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 eg 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None