BCRL Prevention Pilot

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Abramson Cancer Center of the University of Pennsylvania

ClinicalTrials.gov Identifier:

NCT01166672

First received: July 20, 2010

Last updated: October 11, 2012

Last verified: October 2012

History of Changes

Purpose

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.

Condition
Obesity Breast Cancer


Study Type:	Observational
Study Design:	Observational Model: Cohort
Official Title:	Weight Loss to Prevent BCRL: A Pilot Study

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

U.S. FDA Resources

Further study details as provided by Abramson Cancer Center of the University of Pennsylvania:

Primary Outcome Measures:

Follow-up Appts. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
The primary outcome will be the precent of participants who complete 6 month follow-up appointments.

Secondary Outcome Measures:

Response Rates [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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.


Estimated Enrollment:	20
Study Start Date:	July 2010
Study Completion Date:	October 2012
Primary Completion Date:	October 2012 (Final data collection date for primary outcome measure)

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.

Eligibility


Ages Eligible for Study:	18 Years to 70 Years (Adult, Senior)
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No
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.

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01166672

Locations


United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators

Abramson Cancer Center of the University of Pennsylvania

More Information


Responsible Party:	Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier:	NCT01166672 History of Changes
Other Study ID Numbers:	UPCC 15110
Study First Received:	July 20, 2010
Last Updated:	October 11, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Abramson Cancer Center of the University of Pennsylvania:


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:


Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases

ClinicalTrials.gov processed this record on September 28, 2016

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