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BCRL Prevention Pilot

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ClinicalTrials.gov Identifier: NCT01166672
Recruitment Status : Completed
First Posted : July 21, 2010
Last Update Posted : October 12, 2012
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

Study Description
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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.

Condition or disease
Obesity Breast Cancer

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.

Study Design
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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Official Title: Weight Loss to Prevent BCRL: A Pilot Study
Study Start Date : July 2010
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Follow-up Appts. [ Time Frame: 6 months ]
    The primary outcome will be the precent of participants who complete 6 month follow-up appointments.


Secondary Outcome Measures :
  1. Response Rates [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes 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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted: July 21, 2010    Key Record Dates
Last Update Posted: October 12, 2012
Last Verified: October 2012

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.