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Войти в исследования Journal of medical imaging and radiation oncology · 2025
Mepitel Film Versus StrataXRT in Managing Radiation Dermatitis in an Intra-Patient Controlled Clinical Trial of 80 Postmastectomy Patients.
СтатьяМногоцентровое исследованиеКлиническое исследование III фазыРандомизированное исследованиеСравнительное исследованиеНазвание и аннотация: Перевод в очереди
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Herst Patries, van Schalkwyk Mary, Baker Natasha, Thyne Rebecca, Dunne Kelly, Moore Kylie, Jackson Freya, Beaven Kendal, Rutten Lucy, McKee Gemma, Willink Robin, James Melissa
Аннотация
BACKGROUND: Mepitel film decreases the severity of radiation dermatitis in breast cancer patients, but its application is resource-intensive. Many departments therefore use StrataXRT, a gel that patients apply themselves. We compared the protective effects of Mepitel film and StrataXRT on radiation dermatitis during and immediately after radiation therapy.
METHODS: This phase III multicentre randomised intra-patient-controlled clinical trial recruited breast cancer patients receiving radiation therapy following mastectomy in three New Zealand Hospitals. Lateral and medial aspects of the chest wall were randomised to either Mepitel film or StrataXRT. Overall skin reaction severity was measured using RISRAS and RTOG once a week during treatment and for 4 weeks after treatment completion. The primary outcome was moist desquamation (with a non-inferiority margin of 7.5%); secondary outcomes were overall skin reaction severity, patient tolerability, satisfaction and cost.
RESULTS: Between June 2021 and May 2024, 93 patients were recruited, and 80 patients completed the trial. The absolute difference in moist desquamation rates was 6% lower under Mepitel film (p = 0.413, 95% CI -5%, 18%). Overall skin reaction severity was significantly lower for Mepitel film (Researcher RISRAS: p = 0.022; RTOG: p = 0.011). Mepitel film was cheaper to apply but was less well tolerated, with poor skin adherence being an issue for many patients.
CONCLUSION: The study did not show non-inferiority for StrataXRT; overall skin reaction severity and costs were significantly lower under Mepitel film; however, StrataXRT was better tolerated.
TRIAL REGISTRATION: ACTRN12621000124831.
METHODS: This phase III multicentre randomised intra-patient-controlled clinical trial recruited breast cancer patients receiving radiation therapy following mastectomy in three New Zealand Hospitals. Lateral and medial aspects of the chest wall were randomised to either Mepitel film or StrataXRT. Overall skin reaction severity was measured using RISRAS and RTOG once a week during treatment and for 4 weeks after treatment completion. The primary outcome was moist desquamation (with a non-inferiority margin of 7.5%); secondary outcomes were overall skin reaction severity, patient tolerability, satisfaction and cost.
RESULTS: Between June 2021 and May 2024, 93 patients were recruited, and 80 patients completed the trial. The absolute difference in moist desquamation rates was 6% lower under Mepitel film (p = 0.413, 95% CI -5%, 18%). Overall skin reaction severity was significantly lower for Mepitel film (Researcher RISRAS: p = 0.022; RTOG: p = 0.011). Mepitel film was cheaper to apply but was less well tolerated, with poor skin adherence being an issue for many patients.
CONCLUSION: The study did not show non-inferiority for StrataXRT; overall skin reaction severity and costs were significantly lower under Mepitel film; however, StrataXRT was better tolerated.
TRIAL REGISTRATION: ACTRN12621000124831.