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.
- Study Type: Observational
- Study Design
- Time Perspective: Prospective
- Study Primary Completion Date: May 2008
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.
Arms, Groups and Cohorts
- Patients with lymphedema
- Identification of risk factors for lymphedema in women who have had axillary surgery for breast cancer.
- Control patients without lymphedema
- Controls matched on type of axillary surgery and surgery date for comparison in quality of life (QOL) ratings from women who have lymphedema.
Participating in This Clinical Trial
- 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
Gender Eligibility: Female
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
- Lead Sponsor
- HealthPartners Institute
- U.S. Army Medical Research and Development Command
- Provider of Information About this Clinical Study
- Overall Official(s)
- Karen K Swenson, RN, MS, PhDc, Principal Investigator, HealthPartners Institute
Citations Reporting on Results
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.
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.