Back to resultsYoga for Breast Cancer
Primary Purpose
Women With Stage I or II Breast Cancer Undergoing Active Radiation Therapy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Yoga
Sponsored by
About this trial
This is an interventional supportive care trial for Women With Stage I or II Breast Cancer Undergoing Active Radiation Therapy
Eligibility Criteria
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.
Sites / Locations
- Abramson Cancer Center of the University of Pennsylvania
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
No Intervention
Arm Label
Yoga
Without Yoga
Arm Description
Outcomes
Primary Outcome Measures
Number of Adverse Events
Secondary Outcome Measures
Full Information
NCT ID
NCT01985945
First Posted
November 11, 2013
Last Updated
March 10, 2020
Sponsor
Abramson Cancer Center at Penn Medicine
1. Study Identification
Unique Protocol Identification Number
NCT01985945
Brief Title
Yoga for Breast Cancer
Official Title
A Randomized Study of the Effect of Yoga in Patients With Breast Cancer Receiving Radiation Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
December 31, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abramson Cancer Center at Penn Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Women With Stage I or II Breast Cancer Undergoing Active Radiation Therapy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Yoga
Arm Type
Other
Arm Title
Without Yoga
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Yoga
Primary Outcome Measure Information:
Title
Number of Adverse Events
Time Frame
One Year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary Freedman, MD
Organizational Affiliation
Abramson Cancer Center at Penn Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abramson Cancer Center of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
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Yoga for Breast Cancer
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