Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Text Size

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:

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
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

No publications provided

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.

ClinicalTrials.gov processed this record on March 03, 2015