Early Detection and Intervention for Mild and Moderate Lymphedema in Patients Treated for Breast Cancer: A Randomized Trial
- Because no one knows which of the study options is best, participant's will be
randomized into one of the study groups. Participants with mild lymphedema will be
randomized into either Group 1A or Group 1B. Participants with moderate lymphedema
will be randomized into either Group 2A or Group 2B.
- All study participants will meet with a lymphedema physical therapist to review daily
shoulder range of motion exercises to help minimize their arm swelling. They will be
asked to record their range of motion exercises and activities in a study treatment
journal. Participants will bring their journal to each study visit (every 4 weeks).
- Group 1A will only be required to meet with the lymphedema physical therapist as
- Group 1B and Group 2A will be fitted with a compression sleeve at their first
lymphedema physical therapy visit. They will wear the sleeve for a minimum of 12 hours
- Group 2B will also be fitted with a compression sleeve at their first lymphedema
physical therapy visit and will wear the sleeve for a minimum of 12 hours per day.
They will also be instructed to wear a short-stretch compression bandage that goes from
the top of the hand to the armpit. They will be asked to wear this compression bandage
during the night. The overnight compression bandage should be worn for at least 5
nights out of the week.
- Participants will come to the clinic every 4 weeks. The following tests and procedures
will be performed: height and weight measurements; review of any side effects; arm
volume measurements for both arms; questionnaire.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To assess the efficacy of early intervention using compression garments for low volume lymphedema associated with breast cancer treatment.
Alphonse G. Taghian, MD, PhD
Massachusetts General Hospital
United States: Institutional Review Board
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