BCRL Prevention Pilot

Weight Loss to Prevent BCRL: A Pilot Study

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 Overview

• Status: Completed
• Conditions: Obesity; Breast Cancer

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 Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Abramson Cancer Center of The University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Follow-up Appts.	The primary outcome will be the precent of participants who complete 6 month follow-up appointments.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response Rates	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.	6 months

Collaborators and Investigators

• Sponsor: Abramson Cancer Center of the University of Pennsylvania

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: July 20, 2010
• First Submitted That Met QC Criteria: July 20, 2010
• First Posted (Estimate): July 21, 2010

Study Record Updates

• Last Update Posted (Estimate): October 12, 2012
• Last Update Submitted That Met QC Criteria: October 11, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: 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.
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: UPCC 15110