Yoga for Symptoms of Nerve Damage Caused by Chemotherapy

Not Applicable

Completed

• Conditions: Peripheral Neuropathy; Gynecologic Cancer; Breast Cancer
• Interventions: Other: Wait List Control; Other: Yoga

• Registration Number: NCT03292328
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-18
• Study First Submitted: 2017-09-19
• Study First Submitted QC: 2017-09-20
• Study First Posted: 2017-09-25
• Status Verified: 2020-09
• Primary Completion: 2020-09-15
• Study Completion: 2020-09-15
• Last Update Submitted: 2020-09-16
• Last Update Posted: 2020-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Wait List Control Arm (WLC)	Wait List Control	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.
Yoga Arm	Yoga	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.

Primary Outcome Measures

Name	Time	Method
Change in treatment related peripheral neuropathy symptoms	8 weeks of the participants' most bothersome peripheral neuropathy symptom	Treatment related symptoms will be evaluated by using NCI CTCAE v4.0

Trial Locations

Locations (2)

Memoral Sloan Kettering Westchester; 🇺🇸 Harrison, New York, United States

Memorial Sloan - Kettering Cancer Center; 🇺🇸 New York, New York, United States