Abstract OT2-5-01: The PREDICT study (prospective, randomized early detection and intervention after breast cancer - Treatment, for women at risk of lymphedema)

Introduction: It is well-documented that lymphedema is one of the most feared long-term side effects of breast cancer (BC) treatment. However, to date, a standardized approach for the quantification and treatment of breast cancer-related lymphedema (BCRL) has yet to be established. Aims: We propose a screening and intervention trial to assess the efficacy of early detection and intervention with various treatment strategies for BCRL. Intervention comprises the use of compression garments for mild lymphedema and compression garments +/- nighttime bandaging for moderate lymphedema. Other factors to be evaluated include: symptom clusters, treatment adherence, fear avoidance behavior, quality of life (QOL), upper extremity function, and risk factors for BCRL. Eligibility Criteria: Women 18 years + with a confirmed BC diagnosis, no history of BC, no known metastatic or locally advanced disease, no history of primary lymphedema, sentinel lymph node biopsy or axillary lymph node dissection as part of definitive breast surgery. Study Design: A two-stage study which includes a Screening and an Intervention trial. The screening trial will evaluate arm volume change during and after BC treatment with target accrual of 8000. Currently, 1286 participants have been enrolled among three sites including MGH, MD Anderson and Brigham and Women9s Hospital. Patients will undergo perometer measurements and complete the MGH Lymphedema Evaluation Following Treatment for Breast Cancer (LEFT-BC) survey at each screening assessment to evaluate changes in functionality, upper extremity utilization, fear avoidance behaviors, and QOL. Screening visits will occur pre- and post-operatively, at the conclusion of chemotherapy and/or radiation therapy and every 3-8 months thereafter. Patients will become eligible for intervention trial enrollment if, during the course of screening, unilaterally affected patients develop a relative arm volume change (RVC) of ≥ 5% or bilaterally affected patients develop a weight adjusted change (WAC) of ≥ 5% which persists at a verification measurement within 4-8 weeks. Eligible subjects will be enrolled into one of two groups based on verification RVC/WAC: Group I – Mild Lymphedema (5-10% RVC/WAC) or Group II – Moderate Lymphedema (11-20% RVC/WAC). Subjects are then randomized within each group. Group I subjects are randomized to one of two arms: I-A – Observation, I-B – Compression, and Group II subjects are randomized to one of two arms: II-A – Compression, II-B – Compression + Night Compression Bandaging. Target accrual for the intervention trial is 336 subjects (Group I: 208, Group II: 128). Clinical Relevance: The results of this study will yield Level I evidence on the effectiveness of early detection and intervention for BCRL. Findings may shape clinical practice in diagnosis and treatment, as well as provide insight regarding the risk factors, symptoms, upper extremity function, and QOL associated with BCRL.*Funding by award #s R01CA139118 &3P5OCA089393, AGT. Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr OT2-5-01.