Yoga for Symptoms of Nerve Damage Caused by Chemotherapy

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.

Official Title
-----------------
Yoga for Chemotherapy-Induced Peripheral Neuropathy in Breast and GYN Cancer Survivors: A Pilot Study

Conditions
-----------------
Breast Cancer, Peripheral Neuropathy, Gynecologic Cancer

Intervention / Treatment
-----------------
* Other: Yoga
* Other: Wait List Control


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yoga Arm<br>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. | Other: Yoga<br>* 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.<br>|
| Active Comparator: Wait List Control Arm (WLC)<br>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. | Other: Wait List Control<br>* 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 subjects 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in treatment related peripheral neuropathy symptoms | Treatment related symptoms will be evaluated by using NCI CTCAE v4.0 | 8 weeks of the participants' most bothersome peripheral neuropathy symptom | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breast cancer, neuropathy, peripheral neuropathy, yoga, 17-449