Yoga for Symptoms of Nerve Damage Caused by Chemotherapy

NCT ID: NCT03292328

Last Updated: 2025-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-18

Study Completion Date

2020-09-15

Brief Summary

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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

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Conditions

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Breast Cancer Peripheral Neuropathy Gynecologic Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Yoga

Intervention Type OTHER

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.

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.

Group Type ACTIVE_COMPARATOR

Wait List Control

Intervention Type OTHER

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.

Interventions

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Yoga

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 Type OTHER

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 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.

Intervention Type OTHER

Eligibility Criteria

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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


* 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

* Participants with metastatic disease
* Participants who are currently receiving physical therapy or practicing yoga for any reason



* Patients with metastatic disease
* Patients taking anti-neuropathy medication
* Patients who are currently receiving physical therapy or practicing yoga for any reason
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ting Bao, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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Memoral Sloan Kettering Westchester

Harrison, New York, United States

Site Status

Memorial Sloan - Kettering Cancer Center

New York, New York, United States

Site Status

Countries

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United States

References

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Zhi WI, Baser RE, Zhi LM, Talukder D, Li QS, Paul T, Patterson C, Piulson L, Seluzicki C, Galantino ML, Bao T. Yoga for cancer survivors with chemotherapy-induced peripheral neuropathy: Health-related quality of life outcomes. Cancer Med. 2021 Aug;10(16):5456-5465. doi: 10.1002/cam4.4098. Epub 2021 Jul 2.

Reference Type DERIVED
PMID: 34213086 (View on PubMed)

Zhi WI, Chen P, Kwon A, Chen C, Harte SE, Piulson L, Li S, Patil S, Mao JJ, Bao T. Chemotherapy-induced peripheral neuropathy (CIPN) in breast cancer survivors: a comparison of patient-reported outcomes and quantitative sensory testing. Breast Cancer Res Treat. 2019 Dec;178(3):587-595. doi: 10.1007/s10549-019-05416-4. Epub 2019 Aug 27.

Reference Type DERIVED
PMID: 31456070 (View on PubMed)

Related Links

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http://www.mskcc.org

Memorial Sloan Kettering Cancer Center

Other Identifiers

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17-449

Identifier Type: -

Identifier Source: org_study_id

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