NCT00376597

Education With or Without Exercise and Counseling in Preventing Lymphedema in Women With Stage I, Stage II, or Stage III Breast Cancer Who Are Undergoing Axillary Lymph Node Dissection

A Randomized Study to Prevent Lymphedema in Women Treated for Breast Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 568 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This randomized phase III trial studies how well education with or without physical therapy intervention works in preventing lymphedema in women with stage I, II, or III breast cancer who are undergoing axillary lymph node dissection (surgery to remove lymph nodes found in the armpit region). Lymphedema is a condition in which extra lymph fluid builds up in tissues and causes swelling in an arm or leg if lymph vessels are blocked, damaged, or removed by surgery. A personalized physical therapy intervention and education materials may be better than education materials alone in preventing lymphedema in women with breast cancer who are undergoing axillary lymph node dissection.

Detailed description

OBJECTIVES: I. To test, in a group randomized controlled trial, the efficacy of this program versus education only in reducing the incidence of lymphedema. II. To compare the severity of lymphedema, in terms of changes in arm circumference at the site of greatest difference as a continuous variable between the two interventions. III. To assess the agreement between patients' self-report of swelling (mild, moderate, and severe) and the extent of circumferential measurement difference between the treated side and the contralateral arm at the site of greatest difference. IV. To compare the health-related quality of life (Factional Assessment of Cancer Therapy-Breast \[FACT-B\]+4 score) between the two interventions. V. To characterize adherence to lymphedema prevention exercises, lymphedema knowledge, and range of motion. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Six weeks after surgery, patients receive a brief initial post-operative care session describing lymphedema risk and prevention through oral instruction and written materials. Patients complete physical assessments and questionnaires at 6 weeks and at 6, 12, and 18 months. Patients are also contacted by telephone at 9 and 15 months. ARM II: Patients receive lymphedema education and complete physical assessments and questionnaires as in Arm I. Patients also complete a personalized physical therapy intervention, receive a refrigerator magnet, and a 15-minute video that reinforces information and exercises.

Conditions

• Lymphedema

Interventions

Type	Name	Description
OTHER	quality of life assessment	Ancillary studies
OTHER	educational intervention	Receive lymphedema educational materials
PROCEDURE	Physical therapy	Complete physical therapy-focused intervention

Timeline

• Start date: 2006-06-01
• Primary completion: 2015-11-01
• Completion: 2017-06-15
• First posted: 2006-09-15
• Last updated: 2019-02-07
• Results posted: 2017-10-02

Locations

76 sites across 1 country: United States