BCRL Prevention Pilot

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-07-31

Study Completion Date

2012-10-31

Brief Summary

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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

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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.

Conditions

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Obesity Breast Cancer

Keywords

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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.

Study Design

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Observational Model Type

COHORT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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UPCC 15110

Identifier Type: -

Identifier Source: org_study_id