BCRL Prevention Pilot
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01166672 |
Recruitment Status
:
Completed
First Posted
: July 21, 2010
Last Update Posted
: October 12, 2012
|
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Condition or disease |
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Obesity Breast Cancer |
Study Type : | Observational |
Estimated Enrollment : | 20 participants |
Observational Model: | Cohort |
Official Title: | Weight Loss to Prevent BCRL: A Pilot Study |
Study Start Date : | July 2010 |
Actual Primary Completion Date : | October 2012 |
Actual Study Completion Date : | October 2012 |

- Follow-up Appts. [ Time Frame: 6 months ]The primary outcome will be the precent of participants who complete 6 month follow-up appointments.
- Response Rates [ Time Frame: 6 months ]Secondary outcomes will include response rates (% approached who enroll, consent, and attend intervention sessions), weight loss at 6 months, and arm volumes and lymphedema survey responses at 6 months.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- Women
- Breast Cancer Survivors who had 5 or more lymph nodes removed and radiation to lymph nodes as part of treatment.
- Completed all treatments - no metastatic cancers
- Overweight or obese (BMI greater than or equal to 25 kg/m2)
- Medically and logistically able to participate in a weight loss and exercise program over 6 months.
- Diagnosed with breast cancer within the past 2 years.
Exclusion Criteria:
- More than 2 years since breast cancer diagnosis
- Medical status that would preclude safety of participation in a weight loss and exercise program
- Metastatic cancer
- Already enrolled in a weight loss program

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01166672
United States, Pennsylvania | |
Abramson Cancer Center of the University of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104 |
Responsible Party: | Abramson Cancer Center of the University of Pennsylvania |
ClinicalTrials.gov Identifier: | NCT01166672 History of Changes |
Other Study ID Numbers: |
UPCC 15110 |
First Posted: | July 21, 2010 Key Record Dates |
Last Update Posted: | October 12, 2012 |
Last Verified: | October 2012 |
Keywords provided by Abramson Cancer Center of the University of Pennsylvania:
obese women (BMI greater than or equal to 30), do not already have a diagnosis of lymphedema, who are done with surgery, chemotherapy, and radiation therapy, and who were diagnosed with breast cancer within the past 2 years will be invited to participate. |