Clinical trial NCT02305498: Yoga Practice for Breast or Ovarian Cancer Patients
Official title: Yoga Practice for Breast or Ovarian Cancer Patients: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ovarian Cancer
Breast Cancer
Keywords: Yoga
14-059
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: The City College of New York
First posted: 2014-12-02
Enrollment: 39
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: feasibility of a supervised vigorous yoga practice by the number of patients that complete study.
timeFrame: 2 years
measure: safety of a supervised vigorous yoga practice by the number of serious adverse events reported.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Gary Deng, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.