Avon-NCI PFP Program: Predicting Treatment response in ER Positive Breat Cancer

Dana-Farber Cancer Inst, Boston MA

Investigators

Linked publications & trials

Abstract

[unreadable] DESCRIPTION (provided by applicant): The development of lymphedema has a significant negative impact on the patient's quality of life. The management of lymphedema is not supported by data from prospective, randomized, controlled clinical trials. As survival from breast cancer continues to improve, addressing quality of life problems with evidence based interventions is our responsibility as providers of care. The lymphedema incidence is difficult to accurately determine secondary to the inconsistencies surrounding definition, measurement and length of time to follow up. The lymphedema definition is typically > 2 cm difference in arm circumference by tape measure, location of measurement varies; it is often described as >20% volume difference. However, this definition is very subjective with the tape measurement and there is poor inter investigator reliability. The Perometer is now considered the "gold standard" and reliable to within 1%. It measures the volume of the arm using Laser and compares it with the opposite arm. It can detect differences as low as <5%. It is supported in the literature that the risk factors for lymphedema are: axillary dissection, number of nodes removed, number of positive nodes, wound infection, axillary radiation and high BMI. However, unsupported risk factors are: repetitive activity, weight lifting, air flight, BP readings and blood draws. Exercise trials are challenging the precaution regarding weight lifting and early results are favorable. In this study, we establish a reliable method to measure very mild Lymphedema. We will evaluate the natural history of lymphedema and the factors affecting it by measuring the arm volume at baseline and before and after each treatment and twice / year for 5 years. We hypothesize that if Lymphedema is detected early enough (5-10% volume difference), early treatment might prevent it from progression. Therefore, patients with lymphedema of >5-10 % will be randomized between observation and compression therapy for 6 weeks (need 204 pts). We will also, evaluate whether intensive treatment might not be necessary for moderate Lymphedema (10-20% volume difference). Therefore, patients with moderate lymphedema will be randomized between compression therapy + or-wrapping (need 130 pts). Information from this trial should yield data to bring some clarity to these questions and improve the confidence of clinical decision making and improve patient's quality of life. [unreadable] [unreadable]