Yoga Practice for Breast or Ovarian Cancer Patients

NCT ID: NCT02305498

Last Updated: 2019-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-24

Study Completion Date

2019-03-11

Brief Summary

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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.

Detailed Description

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Conditions

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Ovarian Cancer Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vigorous yoga practice

Supervised vigorous yoga practice, 60 minutes/session, 3 sessions/wk for 12 weeks, followed by 12 weeks of home practice.

Group Type EXPERIMENTAL

Vigorous yoga practice

Intervention Type OTHER

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.

Group Type ACTIVE_COMPARATOR

Restorative (gentle) yoga practice

Intervention Type OTHER

Interventions

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Vigorous yoga practice

Intervention Type OTHER

Restorative (gentle) yoga practice

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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The City College of New York

OTHER

Sponsor Role collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gary Deng, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 35861215 (View on PubMed)

Related Links

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http://www.mskcc.org/

Memorial Sloan Kettering Cancer Center

Other Identifiers

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14-059

Identifier Type: -

Identifier Source: org_study_id

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