A Randomized Phase III Clinical Trial of Yoga for Chemotherapy-induced Peripheral Neuropathy Treatment (YCT)

Who is this study for? Patients with Chemotherapy-Induced Peripheral Neuropathy
Status: Recruiting
Location: See all (8) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The purpose of this study is to test whether yoga can reduce nerve pain caused by cancer treatment (chemotherapy-induced peripheral neuropathy, or CIPN). Participants will take one of three approaches: * Yoga classes * Educational sessions on the causes and impacts of CIPN, how yoga may help with CIPN, and how different therapies may help with CIPN * Usual care with standard-of-care medications for CIPN The researchers will compare how these different approaches affect participants' balance, their risk of falls, and their quality of life. This study will also measure how much yoga can help the reduced sense of touch caused by CIPN. The functional assessments TUG and CTS can be safely completed either virtually and in-person and will be mandatory for all patients. The functional assessment FRT and QST assessments that can only be completed in-person are optional at these time points.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• English-proficient men and women aged ≥18 years

• Free of oncologic disease or or stable disease by clinical examination and history

• Completed neurotoxic chemotherapy such as platinum agents, taxanes, vinca alkaloids, and bortezomib at least three months prior to enrollment

• Diagnosis of CIPN based on symptom history, loss of deep tendon reflexes, or the presence of symmetrical stocking-glove pain, numbness, or paresthesia Grade ≥1 sensory pain based on the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

• Self-reported moderate to severe CIPN pain, as defined by a score of 4 or greater on the BPI-SF average pain item over the past week

• On a stable regimen (no change in three months) if taking anti-neuropathy or other pain medications and not taking acetyl-L-carnitine 77

• Willing to adhere to requirement that no new pain medication be taken throughout the first 12 weeks of the study period

• Willing to adhere to all study-related procedures, including randomization to one of the three arms

• Patient answers Yes to at least one factor in the question: Do you think your balance, gait, posture, alignment, or flexibility has been affected by your experience of CIPN?

Locations
United States
Massachusetts
Dana-Farber Cancer Institute
RECRUITING
Boston
New Jersey
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
RECRUITING
Basking Ridge
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
RECRUITING
Middletown
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
RECRUITING
Montvale
New York
Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities)
RECRUITING
Commack
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
RECRUITING
Harrison
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
RECRUITING
Rockville Centre
Contact Information
Primary
Ting Bao, MD
ting_bao@dfci.harvard.edu
(857) 215-2844
Backup
Natalie Viyaran
natalie_viyaran@dfci.harvard.edu
Time Frame
Start Date: 2021-10-29
Estimated Completion Date: 2025-10-01
Participants
Target number of participants: 268
Treatments
Experimental: Yoga
Participants will receive twice weekly yoga over the course of 8 weeks.
Experimental: Education control (EC)
Participants will receive twice weekly education over the course of 8 weeks
Active_comparator: Usual care (UC)
8 weeks of usual care
Authors
Sponsors
Leads: Dana-Farber Cancer Institute
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov