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Clinical Trials/NCT03292328
NCT03292328
Completed
Not Applicable

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

Memorial Sloan Kettering Cancer Center2 sites in 1 country51 target enrollmentSeptember 18, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
Memorial Sloan Kettering Cancer Center
Enrollment
51
Locations
2
Primary Endpoint
Change in treatment related peripheral neuropathy symptoms
Status
Completed
Last Updated
11 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 18, 2017
End Date
September 15, 2020
Last Updated
11 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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

Study Sites (2)

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