Yoga for Chemotherapy-Induced Peripheral Neuropathy in Breast and GYN Cancer Survivors: A Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 51
- Locations
- 2
- Primary Endpoint
- Change in treatment related peripheral neuropathy symptoms
Study Overview
Brief Summary
Some types of chemotherapy used to treat breast cancer can cause damage to nerves with symptoms like tingling, numbness, muscle weakness, and pain in the hands and feet that can last and can affect functioning. The purpose of this study is to find out the effects of yoga on reducing symptoms caused by such nerve damage.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •English-speaking
- •Age >/= 18 years old
- •Survivors with a primary diagnosis of stage I-III breast, ovarian uterine, or endometrial cancer
- •Moderate to severe chemotherapy induced peripheral neuropathy, defined by symptoms such as numbness, tingling, or pain ratings of 4 or greater on a 0-10 numeric rating scale
- •Have completed neurotoxic chemotherapy, i.e. taxanes (paclitaxel, docetaxel) and platinum (carboplatin) at least 3 months prior to enrollment
- •If taking anti-neuropathy medications, they are on a stable regiment (no change in 3 months)
- •ECOG performance status 0-2
Exclusion Criteria
- •Participants with metastatic disease
- •Participants who are currently receiving physical therapy or practicing yoga for any reason
- •Control Group - Inclusion/Exclusion Criteria
- •Inclusion Criteria:
- •English speaking
- •Age >/= 18 years old
- •Survivors with a primary diagnosis of Stage I-III breast, ovarian, uterine, or endometrial cancer
- •CIPN symptoms such as numbness, tingling, or pain ratings < 2 on a 0-10 NRS scale
- •Have completed neurotoxic chemotherapy, i.e. taxanes (paclitaxel, docetaxel) and platinum (carboplatin) at least 3 months prior to enrollment
- •ECOG performance status 0-2
- •Exclusion Criteria:
- •Patients with metastatic disease
- •Patients taking anti-neuropathy medication
- •Patients who are currently receiving physical therapy or practicing yoga for any reason
Arms & Interventions
Yoga Arm
After randomization, participants in the Yoga group will meet twice weekly for 8 weeks of classes taught by MSK yoga instructors. Each class will last for sixty minutes. In addition to these group classes, participants will utilize a home-based program on the days group classes are not held. The daily home practice will continue for four weeks after the group classes are finished.
Intervention: Yoga (Other)
Wait List Control Arm (WLC)
Participants in the WLC group will continue usual care for twelve weeks before participating in Yoga classes for eight weeks. At the end of the twelve week follow-up, these participants will receive eight weeks of group Yoga classes and the home Yoga practice recording. At week 20, they will complete a final follow-up visit.
Intervention: Wait List Control (Other)
Outcomes
Primary Outcomes
Change in treatment related peripheral neuropathy symptoms
Time Frame: 8 weeks of the participants' most bothersome peripheral neuropathy symptom
Treatment related symptoms will be evaluated by using NCI CTCAE v4.0
Secondary Outcomes
No secondary outcomes reported