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Completed

NCT Number: NCT01166672

BCRL Prevention Pilot

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.

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Key information

Conditions

Obesity Body Weight Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

Female

Study type

Observational

Primary location

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Registry information

Official study title

Weight Loss to Prevent BCRL: A Pilot Study

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jul 21, 2010
Registry last updated
Oct 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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