Expired Study
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Philadelphia, Pennsylvania 19104


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.


Study summary:

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.


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


Study is Available At:


Original ID:

UPCC 15110


NCT ID:

NCT01166672


Secondary ID:


Study Acronym:


Brief Title:

BCRL Prevention Pilot


Official Title:

Weight Loss to Prevent BCRL: A Pilot Study


Overall Status:

Completed


Study Phase:

N/A


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

70 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Abramson Cancer Center of the University of Pennsylvania


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Observational Model: Cohort


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

20


Enrollment Type:

Anticipated


Study Dates

Start Date:July 2010
Completion Date:October 2012
Completion Type:Actual
Primary Completion Date:October 2012
Primary Completion Type:Actual
Verification Date:October 2012
Last Changed Date:October 11, 2012
First Received Date:July 20, 2010

Study Outcomes

Outcome Type:Primary Outcome
Measure:Follow-up Appts.
Time Frame:6 months
Safety Issues:False
Description:The primary outcome will be the precent of participants who complete 6 month follow-up appointments.
Outcome Type:Secondary Outcome
Measure:Response Rates
Time Frame:6 months
Safety Issues:False
Description: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.

Study Interventions

There are no available Study Interventions

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Abramson Cancer Center of the University of Pennsylvania

Samples and Retentions

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.
Sample Method:Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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