Yoga for Symptoms of Nerve Damage Caused by Chemotherapy

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03292328
• Other study ID #: 17-449
• Status: Completed
• Phase: N/A
• Start date: September 18, 2017
• Est. completion date: September 15, 2020

Study information

• Verified date: September 2020
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: September 15, 2020
• Est. primary completion date: September 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Gynecologic Cancer
• Peripheral Nervous System Diseases
• Peripheral Neuropathy

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Memoral Sloan Kettering Westchester	Harrison	New York
United States	Memorial Sloan - Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Memorial Sloan Kettering Cancer Center