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Yoga for Symptoms of Nerve Damage Caused by Chemotherapy

Primary Purpose

Breast Cancer, Peripheral Neuropathy, Gynecologic Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Yoga
Wait List Control
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring breast cancer, neuropathy, peripheral neuropathy, yoga, 17-449

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Memoral Sloan Kettering Westchester
  • Memorial Sloan - Kettering Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Yoga Arm

Wait List Control Arm (WLC)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in treatment related peripheral neuropathy symptoms
Treatment related symptoms will be evaluated by using NCI CTCAE v4.0

Secondary Outcome Measures

Full Information

First Posted
September 19, 2017
Last Updated
September 16, 2020
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT03292328
Brief Title
Yoga for Symptoms of Nerve Damage Caused by Chemotherapy
Official Title
Yoga for Chemotherapy-Induced Peripheral Neuropathy in Breast and GYN Cancer Survivors: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
September 18, 2017 (Actual)
Primary Completion Date
September 15, 2020 (Actual)
Study Completion Date
September 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Peripheral Neuropathy, Gynecologic Cancer
Keywords
breast cancer, neuropathy, peripheral neuropathy, yoga, 17-449

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Yoga Arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Wait List Control Arm (WLC)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Yoga
Intervention Description
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
Intervention Name(s)
Wait List Control
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in treatment related peripheral neuropathy symptoms
Description
Treatment related symptoms will be evaluated by using NCI CTCAE v4.0
Time Frame
8 weeks of the participants' most bothersome peripheral neuropathy symptom

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ting Bao, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memoral Sloan Kettering Westchester
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Facility Name
Memorial Sloan - Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34213086
Citation
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.
Results Reference
derived
PubMed Identifier
31456070
Citation
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.
Results Reference
derived
Links:
URL
http://www.mskcc.org
Description
Memorial Sloan Kettering Cancer Center

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Yoga for Symptoms of Nerve Damage Caused by Chemotherapy

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