Predictors of Lymphedema Following Breast Cancer Surgery

Completed

• Conditions: Breast Cancer; Lymphedema

• Registration Number: NCT00202046
• Lead Sponsor: HealthPartners Institute

Brief Summary

The purpose of this study evaluate which factors play a role in lymphedema development among women who have had axillary surgery for breast cancer. Potential risk factors for women who have developed lymphedema will be compared to risk factors among women who have not developed lymphedema after breast cancer surgery.

Detailed Description

Surgery for breast cancer includes removal of the breast tumor along with the axillary lymph nodes. The status of these nodes helps clinicians determine prognosis and guides treatment decisions. Unfortunately, a relatively common side effect following axillary lymph node dissection is upper-extremity lymphedema. The purpose of this study is to identify risk factors for lymphedema among women who have had axillary surgery for breast cancer. Specific aims include identifying risk factors for lymphedema and comparing quality of life (QOL) ratings for women who have and do not have lymphedema. A case-control study will be conducted with enrollment of 200 participants. Cases will be identified at their lymphedema consult in the physical therapy centers. Using the oncology registry, controls will include patients who have had breast cancer surgery and have not developed lymphedema. The severity of lymphedema and interference with daily life will be assessed with the Measure of Arm Symptom Survey (MASS), a patient-completed survey, and QOL will be collected with the SF-36. Treatment risk factors including previous surgery, radiotherapy and chemotherapy will be obtained from oncology registry data. This study will determine which factors play a role in lymphedema development.

Study Timeline

• Study Start: 2003-01
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-20
• Status Verified: 2007-04
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Last Update Submitted: 2015-12-02
• Last Update Posted: 2015-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 188

Inclusion Criteria

• Clinical diagnosis of lymphedema
• Axillary node surgery by sentinel node or axillary node dissection
• No known metastatic disease in the axilla
• Able and willing to give informed consent

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (3)

Fairview University; 🇺🇸 Minneapolis, Minnesota, United States

North Memorial Medical Center; 🇺🇸 Minneapolis, Minnesota, United States

Park Nicollet Institute; 🇺🇸 St. Louis Park, Minnesota, United States