Randomized study of electric hand warmer (EHW) versus observation to avoid discomfort during scalp cooling for chemotherapy-induced alopecia (CIA) prevention.

Abstract

12108 Background: CIA has been reported as the most disturbing adverse event of cancer treatment by most women receiving chemotherapy. Many strategies have been tested to minimize CIA, among which scalp cooling has proven high effectiveness. However, discontinuation rates of this technology vary from 3% to 13%, mostly due to headache, cold sensation and pain. EHW could be used to mitigate these side effects, produce heat on demand and a warming sensation. The primary objective of this study is to evaluated the impact of EHW device on the general comfort of breast cancer patients while on scalp cooling during chemotherapy treatment. Methods: Patients were randomly assigned to EHW use or observation. Thermal, sensory and general comfort were measured with pragmatic questionnaires after each chemotherapy infusion: neutral or hot as favorable thermal responses; comfortable and very comfortable as favorable sensory responses; finally, favorable outcomes in both thermal and sensory comfort questionnaires defined a positive result on the general comfort. We evaluated the impact of age (≤ or > 50 years), alopecia (grade 0 or 1/2), chemotherapy regimen (with or without taxanes) and EHW use (yes or no) in the different comfort scales using Logistic Regression (LR) models. Results: Forty women with early or locally advanced breast cancer were assigned to EHW (n = 20) or observation (n = 20) during neo(adjuvant) chemotherapy. Median age was 53 years, 67.5% concluded university education, 52.5% had comorbidities. Most patients had stage II disease (55%), largely ER/PR+ HER2- disease (67.5%), followed by triple negative (22.5%), and HER2+ (10%). Most frequent regimen was ACdd-Tdd (42.5%). Thirty-one patients (77.5%) continued scalp cooling during entire chemotherapy regimen (alopecia < grade 3). A favorable thermal response was seen in 79% of EHW applications as compared to 50% in control arm (odds ratio [OR] 3.79, P <.001). Sensory comfort was satisfactory in 82% of EHW applications as compared to 74% with control (OR 1.62, P =.1). General comfort was favorable in 73% of EHW applications as compared to 44% in control arm (OR 3.4, P <.001). Age, alopecia grade and taxane use did not significantly impact on comfort measures. Conclusions: Our study suggests that an EHW has a consistent favorable impact on thermal and general comfort of breast cancer patients under scalp cooling technology to prevent CIA. This simple device can improve patient´s quality of life and eventually avoid scalp cooling discontinuation due to discomfort.