StrataXRT and Mepitel Film for Preventing Postmastectomy Acute Radiation Dermatitis in Breast Cancer: An Intrapatient Noninferiority Randomized Clinical Trial.

PURPOSE

Acute radiation dermatitis (ARD) is a notable challenge for patients with breast cancer undergoing postmastectomy radiation therapy (RT). This study evaluates the efficacy, safety, and user experience of StrataXRT versus Mepitel Film for ARD prevention.

METHODS AND MATERIALS

This multicenter, noninferiority trial involved intrapatient randomization of 44 patients with histologically confirmed breast carcinoma who had undergone postmastectomy RT across 4 Australian hospitals from January 1 to December 31, 2017. Patients were randomly assigned to receive Mepitel Film and StrataXRT on alternate halves of the irradiated chest wall. Mepitel Film was applied by nurses and replaced every 1 to 2 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 < .001). Secondary outcomes-mean difference in TWA grade in chest wall halves, worst ARD grade, and incidence of moist desquamation-showed noninferiority between treatments. Patient preferences were closely matched, with 37.5% favoring StrataXRT and 40% Mepitel Film. StrataXRT caused itching in 1 patient and Mepitel Film in 3, leading to 1 removal.

CONCLUSIONS

Although StrataXRT did not meet the noninferiority 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 postmastectomy 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.