Yoga Practice for Breast or Ovarian Cancer Patients

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02305498
• Other study ID #: 14-059
• Status: Completed
• Phase: N/A
• Start date: November 24, 2014
• Est. completion date: March 11, 2019

Study information

• Verified date: March 2019
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: March 11, 2019
• Est. primary completion date: March 11, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Other:
• Vigorous yoga practice

• Restorative (gentle) yoga practice

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	The City College of New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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

External Links

•   Memorial Sloan Kettering Cancer Center