For example (unfortunately, this one is in Stanford, CA and not accessible to me):
Lymphedema Prevention and Detection
To Prospectively Evaluate the Potential for Simple, Effective Lymphedema Prophylaxis in Breast Cancer Survivors Who Show Early Evidence of High-Risk Status
Purpose
The purpose of this research study is to detect patients who might be at increased risk for the development of arm lymphedema based upon repeated non-invasive examination of the arms. When preventive interventions are appropriate, this study will compare the effectiveness of the usual treatments of massage and elastic sleeves with a new device, Flexitouch, which electronically simulates the effect of massage upon lymph flow.
Study groups
All participants will be monitored for evidence of early impairment in lymphatic function. Prior to surgery and once every 3 months after surgery, arm volume measurements and bioelectric impedance analysis (BIA) will be performed.
If a significant increase in BIA occurs, participants will be randomly assigned to 1 of 3 preventive treatment groups:
- Standard Care: Self-administered lymphatic massage in addition to a standard compression sleeve
- Flexitouch: Use the Flexitouch device to stimulate the lymphatics in addition to a standard compression sleeve
- Continued Follow-Up: Continued monitoring of both arms
Additional procedures
If signs of lymphedema develop, a small punch biopsy of the skin will be taken. Blood samples for study purposes. Optional donation of breast tissue and skin from surgery.
Trial length
24 months
Post-trial follow-up
Regulary, up to 5 years
Sponsor
Other
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