Yoga for Symptoms of Nerve Damage Caused by Chemotherapy
Keywords
Abstract
Dates
| Last Verified: | 09/30/2019 |
| First Submitted: | 09/18/2017 |
| Estimated Enrollment Submitted: | 09/19/2017 |
| First Posted: | 09/24/2017 |
| Last Update Submitted: | 03/01/2020 |
| Last Update Posted: | 03/02/2020 |
| Actual Study Start Date: | 09/17/2017 |
| Estimated Primary Completion Date: | 09/17/2021 |
| Estimated Study Completion Date: | 09/17/2021 |
Condition or disease
Intervention/treatment
Other: Yoga Arm
Other: Wait List Control Arm (WLC)
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: 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. | Other: Yoga Arm 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. |
| Active Comparator: 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. | 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 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. |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| 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 |
Outcome
Primary Outcome Measures
1. Change in treatment related peripheral neuropathy symptoms [8 weeks of the participants' most bothersome peripheral neuropathy symptom]
