Yoga for Symptoms of Nerve Damage Caused by Chemotherapy

NCT03292328 | Completed DMC

• 1 other identifier: 17-449
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Cancer; Peripheral Neuropathy; Gynecologic Cancer

Keywords

breast cancer; neuropathy; peripheral neuropathy; yoga; 17-449

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Yoga Arm

EXPERIMENTAL

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

Wait List Control Arm (WLC)

ACTIVE COMPARATOR

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

Interventions

Yoga 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.

Yoga Arm

Wait List Control 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.

Wait List Control Arm (WLC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Participants with metastatic disease
• Participants who are currently receiving physical therapy or practicing yoga for any reason
• 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
• Patients with metastatic disease
• Patients taking anti-neuropathy medication
• Patients who are currently receiving physical therapy or practicing yoga for any reason

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (2)

Memoral Sloan Kettering Westchester

Harrison, New York, 10604, United States

Location

Memorial Sloan - Kettering Cancer Center

New York, New York, 10021, United States

Location

Related Publications (2)

• 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.

  PMID: 34213086 DERIVED

• 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.

  PMID: 31456070 DERIVED

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Breast Neoplasms; Peripheral Nervous System Diseases

Interventions

Yoga

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Ting Bao, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2017
• First Posted: September 25, 2017
• Study Start: September 18, 2017
• Primary Completion: September 15, 2020
• Study Completion: September 15, 2020
• Last Updated: May 13, 2025

Record last verified: 2020-09

Locations

US (2)