Yoga Practice for Breast or Ovarian Cancer Patients

March 13, 2019 updated by: Memorial Sloan Kettering Cancer Center

Yoga Practice for Breast or Ovarian Cancer Patients: A Pilot Study

Previous research suggests that regular physical activity may make cancer survivors do better in the long run. Laboratory studies suggest that stress may be bad for cancer patients as well. The investigators are interested in whether yoga, a practice that combines physical activity and stress reduction, is beneficial to cancer survivors. To answer that question, the investigators will need to do a large scale clinical trial.

Before the investigators can do that large study, they need to know whether people are willing to participate in this kind of study, whether they can do the yoga practice regularly and for how long, what kind of changes they may experience in how they can handle their daily activities, emotion, sleep, memory and problem solving ability, and what are the changes that can happen in their body after doing the yoga practice. Answering these questions is what this study is about.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Woman age 18 or older
  • History of stage 0-III breast cancer or stage I-III ovarian cancer; all antitumor therapies, excluding hormonal therapy, have been completed at least 60 days prior to enrollment
  • ECOG Performance Status 0-1 (within 90 days of enrollment)
  • Sedentary: <90 minutes/week of moderate-intensity (not exhausting, light perspiration, e.g. fast walking, tennis, easy bicycling, easy swimming, popular and folk dancing) physical activity during the preceding 2 months, and <30 minutes/month of any high-intensity activity (heart beats rapidly, sweating, e.g. running, aerobics classes, cross country skiing, vigorous swimming, vigorous bicycling) in the past 2 months

Exclusion Criteria:

  • Evidence of active malignant disease
  • Currently has breast implant (which limits the performance of many yoga poses)
  • Significant cardiopulmonary disease, severe arthritis, glaucoma or any other medical conditions that make yoga practice unsafe as determined by a study investigator.
  • Patient requires regular use of beta blockers or calcium channel blockers.
  • Use of any medication that would interfere with the study's initial blood tests, including insulin or insulin secretagogues, corticosteroids, daily use of NSAIDs (except aspirin at no more than 81 mg/day) within 7 days of the initial study blood test.
  • Unlikely to be compliant with the study intervention

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vigorous yoga practice
Supervised vigorous yoga practice, 60 minutes/session, 3 sessions/wk for 12 weeks, followed by 12 weeks of home practice.
Other: Vigorous yoga practice
Active Comparator: Restorative (gentle) yoga practice
Supervised restorative (gentle) yoga practice, 60 minutes/session, 3 sessions/wk for 12 weeks, followed by 12 weeks of home practice.
Other: Restorative (gentle) yoga practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
feasibility of a supervised vigorous yoga practice by the number of patients that complete study.
Time Frame: 2 years
The study will be deemed feasible and safe if at least 15/20 patients in each arm complete the study. If the underlying feasibility rate is 90%, then the probability of 15/20 patients or more completing the study is 98.9%, and 97.8% for 15/20 patients completing in the study in both arms simultaneously.
2 years
safety of a supervised vigorous yoga practice by the number of serious adverse events reported.
Time Frame: 2 years
Each serious adverse event (SAE), defined as grade III or IV toxicity, will be evaluated by the PI or a Co-PI and its relationship to the study intervention is determined by the PI or a Co-PI. The study will be deemed feasible and safe if at least 15/20 patients in each arm complete the study.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

The City College of New York

Investigators

  • Principal Investigator: Gary Deng, MD, PhD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 24, 2014

Primary Completion (Actual)

March 11, 2019

Study Completion (Actual)

March 11, 2019

Study Registration Dates

First Submitted

November 25, 2014

First Submitted That Met QC Criteria

November 26, 2014

First Posted (Estimate)

December 2, 2014

Study Record Updates

Last Update Posted (Actual)

March 14, 2019

Last Update Submitted That Met QC Criteria

March 13, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-059 (Other Identifier: US Oncology Research/McKesson Specialty Health, Inc.)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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