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Yoga for Symptoms of Nerve Damage Caused by Chemotherapy

This study is currently recruiting participants.
Verified September 2017 by Memorial Sloan Kettering Cancer Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT03292328
First Posted: September 25, 2017
Last Update Posted: September 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
  Purpose
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.

Condition Intervention
Breast Cancer Peripheral Neuropathy Other: Yoga Other: Wait List Control

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Yoga for Chemotherapy-Induced Peripheral Neuropathy in Breast Cancer Survivors: A Pilot Study

Resource links provided by NLM:


Further study details as provided by Memorial Sloan Kettering Cancer Center:

Primary Outcome Measures:
  • Change in treatment related peripheral neuropathy symptoms [ Time Frame: 8 weeks of the participants' most bothersome peripheral neuropathy symptom ]
    Treatment related symptoms will be evaluated by using NCI CTCAE v4.0


Estimated Enrollment: 40
Actual Study Start Date: September 18, 2017
Estimated Study Completion Date: September 18, 2018
Estimated Primary Completion Date: September 18, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • English-speaking
  • Age >/= 18 years old
  • Survivors with a primary diagnosis of stage I-III breast 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03292328


Contacts
Contact: Ting Bao, MD 646-888-0865 baot@mskcc.org
Contact: Jun Mao, MD, MSCE 146-888-0866 maoj@mskcc.org

Locations
United States, New York
Memoral Sloan Kettering Westchester Recruiting
Harrison, New York, United States, 10604
Contact: Ting Bao, MD    646-888-0865      
Memorial Sloan - Kettering Cancer Center Recruiting
New York, New York, United States, 10021
Contact: Ting Bao, MD    646-888-0865      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
  More Information

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT03292328     History of Changes
Other Study ID Numbers: 17-449
First Submitted: September 19, 2017
First Posted: September 25, 2017
Last Update Posted: September 25, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Memorial Sloan Kettering Cancer Center:
breast cancer
neuropathy
peripheral neuropathy
yoga
17-449

Additional relevant MeSH terms:
Breast Neoplasms
Peripheral Nervous System Diseases
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neuromuscular Diseases
Nervous System Diseases