BCRL Prevention Pilot

Completed

• Conditions: Obesity; Breast Cancer

• Registration Number: NCT01166672
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-07-20
• Study First Submitted QC: 2010-07-20
• Study First Posted: 2010-07-21
• Status Verified: 2012-10
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Last Update Submitted: 2012-10-11
• Last Update Posted: 2012-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Follow-up Appts.	6 months	The primary outcome will be the precent of participants who complete 6 month follow-up appointments.

Secondary Outcome Measures

Name	Time	Method
Response Rates	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.

Trial Locations

Locations (1)

Abramson Cancer Center of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States