BCRL Prevention Pilot

Weight Loss to Prevent BCRL: A Pilot Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01166672

Enrollment

Registered

2010-07-21

Start date

2010-07-31

Completion date

2012-10-31

Last updated

2012-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Obesity

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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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.

Countries

United States

Outcome results