Predictors of Lymphedema Following Breast Cancer Surgery

Breast Cancer Clinical Trial

Official title:

Predictors of Lymphedema Following Breast Cancer Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00202046
• Other study ID #: 1728-03-B
• Secondary ID: DAMD17-03-0738
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: December 2, 2015
• Start date: January 2003
• Est. completion date: May 2008

Study information

• Verified date: April 2007
• Source: HealthPartners Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 188
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Lymphedema

Locations

Country	Name	City	State
United States	Fairview University	Minneapolis	Minnesota
United States	North Memorial Medical Center	Minneapolis	Minnesota
United States	Park Nicollet Institute	St. Louis Park	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
HealthPartners Institute	U.S. Army Medical Research and Materiel Command

Country where clinical trial is conducted

United States, 

References & Publications (1)

Swenson KK, Nissen MJ, Leach JW, Post-White J. Case-control study to evaluate predictors of lymphedema after breast cancer surgery. Oncol Nurs Forum. 2009 Mar;36(2):185-93. doi: 10.1188/09.ONF.185-193. — View Citation