BCRL Prevention Pilot

Breast Cancer Clinical Trial

Official title:

Weight Loss to Prevent BCRL: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01166672
• Other study ID #: UPCC 15110
• Status: Completed
• Phase: N/A
• First received: July 20, 2010
• Last updated: October 11, 2012
• Start date: July 2010
• Est. completion date: October 2012

Study information

• Verified date: October 2012
• Source: Abramson Cancer Center of the University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Observational Model: Cohort

Related Conditions & MeSH terms

• Breast Cancer
• Obesity

Locations

Country	Name	City	State
United States	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center of the University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Follow-up Appts.	The primary outcome will be the precent of participants who complete 6 month follow-up appointments.	6 months	No
Secondary	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	No