- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01985945
Yoga for Breast Cancer
March 10, 2020 updated by: Abramson Cancer Center of the University of Pennsylvania
A Randomized Study of the Effect of Yoga in Patients With Breast Cancer Receiving Radiation Therapy
The purpose of this study is to examine the use of Eischens yoga for 8 weeks in one cohort of 20 women with stage I and II breast cancer receiving radiation therapy treatment, while a second cohort of the same type of and number of patients who, instead of yoga will receive standard supportive therapy, Questionnaire measuring cancer-related quality of life (FACT-G instrument) and fatigue (Brief Fatique Inventory) will be given to patients at several points.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
70
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
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- Abramson Cancer Center of the University of Pennsylvania
-
-
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:
- Stage I and II breast cancer patients undergoing active radiation therapy
- Above the age of 18
- Must sign informed consent form
- Must speak English
- Only women are eligible
Exclusion Criteria:
- Patients with medical restrictions that may interfere with yoga participation per their physicians' decision
- Those who have smoked in the last 6 months because smoking can interfere with the breathing and relaxation techniques of yoga.
- Those who have regularly taken yoga in the last 6 months, because they would not come to the intervention with the same baseline as other participants.
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: SUPPORTIVE_CARE
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
OTHER: Yoga
|
|
|
NO_INTERVENTION: Without Yoga
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of Adverse Events
Time Frame: One Year
|
One Year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Gary Freedman, MD, Abramson Cancer Center of the University of Pennsylvania
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
March 1, 2013
Primary Completion (ACTUAL)
July 1, 2015
Study Completion (ACTUAL)
December 31, 2015
Study Registration Dates
First Submitted
November 11, 2013
First Submitted That Met QC Criteria
November 11, 2013
First Posted (ESTIMATE)
November 18, 2013
Study Record Updates
Last Update Posted (ACTUAL)
March 11, 2020
Last Update Submitted That Met QC Criteria
March 10, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UPCC 08113
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.