Expired Study
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Philadelphia, Pennsylvania 19104


The purpose of this study is to establish feasiblity of recruiting obese breast cancer survivors at the end of treatment, getting those survivors to lose weight and attend follow-up visits for 6 months.

Study summary:

Breast cancer related lymphedema occurs in 20-30% of survivors. Weight loss could prevent onset. We seek to do a pilot study to establish feasibility of 1) recruiting survivors at risk for lymphedema to do a weight loss intervention, 2) achieving 10-15% weight loss over 26 weeks in this population, and 3) attendance at follow-up visits 6 months.


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

Study is Available At:

Original ID:

UPCC 15110



Secondary ID:

Study Acronym:

Brief Title:

BCRL Prevention Pilot

Official Title:

Weight Loss to Prevent BCRL: A Pilot Study

Overall Status:


Study Phase:




Minimum Age:

18 Years

Maximum Age:

70 Years

Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Abramson Cancer Center of the University of Pennsylvania

Oversight Authority:

United States: Institutional Review Board

Reasons Why Stopped:

Study Type:


Study Design:

Observational Model: Cohort

Number of Arms:


Number of Groups:


Total Enrollment:


Enrollment Type:


Study Dates

Start Date:July 2010
Completion Date:October 2012
Completion Type:Actual
Primary Completion Date:October 2012
Primary Completion Type:Actual
Verification Date:October 2012
Last Changed Date:October 11, 2012
First Received Date:July 20, 2010

Study Outcomes

Outcome Type:Primary Outcome
Measure:Follow-up Appts.
Time Frame:6 months
Safety Issues:False
Description:The primary outcome will be the precent of participants who complete 6 month follow-up appointments.
Outcome Type:Secondary Outcome
Measure:Response Rates
Time Frame:6 months
Safety Issues:False
Description: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.

Study Interventions

There are no available Study Interventions

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Abramson Cancer Center of the University of Pennsylvania

Samples and Retentions

Study Population: Women, aged 18-70, who are obese (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.
Sample Method:Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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