Yoga Practice for Breast or Ovarian Cancer Patients
1 other identifier
interventional
39
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable ovarian-cancer
Started Nov 2014
Typical duration for not_applicable ovarian-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 24, 2014
CompletedFirst Submitted
Initial submission to the registry
November 25, 2014
CompletedFirst Posted
Study publicly available on registry
December 2, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 11, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 11, 2019
CompletedMarch 14, 2019
March 1, 2019
4.3 years
November 25, 2014
March 13, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
feasibility of a supervised vigorous yoga practice by the number of patients that complete study.
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.
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
Study Arms (2)
Vigorous yoga practice
EXPERIMENTALSupervised vigorous yoga practice, 60 minutes/session, 3 sessions/wk for 12 weeks, followed by 12 weeks of home practice.
Restorative (gentle) yoga practice
ACTIVE COMPARATORSupervised restorative (gentle) yoga practice, 60 minutes/session, 3 sessions/wk for 12 weeks, followed by 12 weeks of home practice.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Related Publications (1)
Deng G, Bao T, Ryan EL, Benusis L, Hogan P, Li QS, Dries A, Konner J, Ahles TA, Mao JJ. Effects of Vigorous Versus Restorative Yoga Practice on Objective Cognition Functions in Sedentary Breast and Ovarian Cancer Survivors: A Randomized Controlled Pilot Trial. Integr Cancer Ther. 2022 Jan-Dec;21:15347354221089221. doi: 10.1177/15347354221089221.
PMID: 35861215DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gary Deng, MD, PhD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 25, 2014
First Posted
December 2, 2014
Study Start
November 24, 2014
Primary Completion
March 11, 2019
Study Completion
March 11, 2019
Last Updated
March 14, 2019
Record last verified: 2019-03