Abstract OT3-07-01: A randomized trial evaluating bioimpedance spectroscopy vs. tape measurement in the prevention of lymphedema following breast cancer treatment

Abstract

Abstract Background: Breast cancer related lymphedema (BCRL) represents a common treatment associated complication following surgery, radiation and/or chemotherapy. Increasing data has demonstrated the ability of new diagnostic modalities to detect BCRL in the subclinical phase of the process allowing for early intervention. Trial Design: This 2-group stratified randomized clinical trial evaluates the effectiveness of bioimpedance spectroscopy (BIS) for early detection and prevention of BCRL compared to tape measurement (TM). Baseline assessments are made pre-operatively. Two-months post-op, patients are censored out if they have developed any of the exclusion conditions, did not have a mastectomy, axillary dissection, >6 sentinel nodes removed, radiation therapy, or taxane. Remaining patients are randomized within site to either BIS or TM; monitored at 3 to 6-month intervals up to 36-months post-op for a change over baseline specified to trigger a compression sleeve & gauntlet intervention. Cohort trigger thresholds are change of ≥10 L-Dex units or 5 to <10% volume. If the intervention is triggered, measurements by the other method are taken before initiating the 4-week intervention. Post intervention, patients are monitored only with TM. Volume change of ≥10% results in study removal and physician referral. At the 2 study endpoints (36 month visit or volume change of ≥10%) measurements are taken with each method. Eligibility Criteria: Inclusion criteria: ≥ 18 with histologically confirmed stage I-III breast cancer (BC) or DCIS with planned surgery. Exclusion criteria include history of BC therapy or lymphedema. Specific Aims: The primary hypothesis is that subclinical detection of BCRL with BIS and early intervention will reduce the rate of lymphedema progression (as measured by referral to complex decongestive physiotherapy) compared to TM. Secondary outcomes include BCRL risk factors, quality of life, and time to treatment. Statistical Methods: Sample size and powering were based on the hypothesis that BIS would reduce progression rate by 20%. A rate of 50% progression in the TM group was used as the standard. 1100 patients will be enrolled to result in randomized groups of 100 (Total N=200) Statistics include relative risks with respective bootstrapped 95% C.I. and Cochran-Mantel-Haenszel tests. Present Accrual and Target Accrual: Overall, the study target or expected enrollment as of the end of March 31, 2016 was 690 participants, 534 were actually enrolled (actual accrual 77% of target). Accrual at the study sites ranged from 15 to 104% of target. Contact Information: Sheila Ridner: 615-322-0831, Sheila.ridner@vanderbilt.edu Support: ImpediMed Limited, ImpediMed, Inc. and medi USA. Citation Format: Ridner S, Shah C, Dietrich M, Vicini F. A randomized trial evaluating bioimpedance spectroscopy vs. tape measurement in the prevention of lymphedema following breast cancer treatment [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr OT3-07-01.