StrataXRT and Mepitel Film for preventing post-mastectomy acute radiation dermatitis in breast cancer: an intra-patient non-inferiority randomized clinical trial.
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引用次数: 0
Abstract
Purpose: Acute radiation dermatitis (ARD) is a notable challenge for patients with breast cancer undergoing post-mastectomy radiation therapy (RT). This study evaluates the efficacy, safety, and user experience of StrataXRT versus Mepitel Film for ARD prevention.
Methods: This multicenter, non-inferiority trial involved intra-patient randomization of 44 histologically confirmed breast carcinoma patients undergoing post-mastectomy RT across four Australian hospitals from January 1 to December 31, 2017. Patients were randomized to receive Mepitel Film and StrataXRT on alternate halves of the irradiated chest wall. Mepitel Film was applied by nurses and replaced every one to two weeks or as necessary, ensuring continuous coverage throughout RT. Conversely, patients self-applied StrataXRT daily to the opposite half, with adherence details recorded in patient diaries. The primary outcome was the mean difference in the time-weighted average (TWA) grade of ARD within designated rectangles in each half over 10 weeks from the commencement of RT.
Results: Forty patients were analyzed per-protocol. Measurements using thermoluminescent dosimeters showed no significant dose differences between medial and lateral rectangles. StrataXRT was inferior to Mepitel Film in the primary outcome, with a mean difference in TWA grade of 0.19 (95%confidence interval: 0.12-0.26; P<0.001). Secondary outcomes-mean difference in TWA grade in chest wall halves, worst ARD grade, and incidence of moist desquamation-showed non-inferiority between treatments. Patient preferences were closely matched, with 37.5% favoring StrataXRT and 40% Mepitel Film. StrataXRT caused itching in one patient and Mepitel Film in three, leading to one removal.
Conclusion: Although StrataXRT did not meet the non-inferiority threshold in the primary outcome and is considered inferior, its ease of application and patient acceptance suggest that it may still be offered for ARD prevention in post-mastectomy RT when Mepitel Film is not a practical option. Open discussion with patients and caregivers is recommended to determine the most appropriate skin protection agent, considering both efficacy and practicality.
期刊介绍:
International Journal of Radiation Oncology • Biology • Physics (IJROBP), known in the field as the Red Journal, publishes original laboratory and clinical investigations related to radiation oncology, radiation biology, medical physics, and both education and health policy as it relates to the field.
This journal has a particular interest in original contributions of the following types: prospective clinical trials, outcomes research, and large database interrogation. In addition, it seeks reports of high-impact innovations in single or combined modality treatment, tumor sensitization, normal tissue protection (including both precision avoidance and pharmacologic means), brachytherapy, particle irradiation, and cancer imaging. Technical advances related to dosimetry and conformal radiation treatment planning are of interest, as are basic science studies investigating tumor physiology and the molecular biology underlying cancer and normal tissue radiation response.