ArticleClinical and translational radiation oncology2025
Mepitel® film versus standard care for the prevention of skin toxicity in breast cancer patients treated with adjuvant radiotherapy: A randomized controlled trial.
Article in Clinical and translational radiation oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
2 citing papers in PubMed, 1 synthesis or guideline pooled it.
- MASCC oncodermatology clinical practice statement: prevention and management of acute radiation dermatitis with Mepitel Film and Hydrofilm.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2025Guideline
- StrataXRT Versus Mepitel Film for Prevention of Acute Radiation Dermatitis in Postmastectomy Radiotherapy: A Pooled Analysis of Intra-Patient Randomised Trials.Journal of medical radiation sciences · 2026Article
Corrections and comments
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Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background & purpose: Radiotherapy plays a key role in breast cancer treatment however, radiation-induced dermatitis can impact on treatment delivery and patient quality of life.The primary outcome was to compare Mepitel® Film versus standard treatment in preventing radiotherapy skin toxicity onset. Methods: A multicentre randomised controlled phase III study compared standard treatment (aqueous-urea cream - Excipial U hydrolotion applied at the beginning of radiotherapy and antiseptic cream - Flammazine or Ialugen Plus applied at the onset of moist desquamation) versus Mepitel® Film in patients with breast cancer undergoing post-operative radiotherapy. The primary outcome was the proportion of moist desquamation (RTOG score ≥ 2) in the experimental and control groups. Results: During the study (2016-2020), 161 patients were randomized, 154 (95.7 %) were evaluable. Skin toxicity Radiation Therapy Oncology Group (RTOG) score ≥ 2 was observed in 9.5 % and 13.9 % of experimental and control groups respectively (Relative Risk = 0.68, 95 %CI 0.28-1.66; p = 0.393). RTOG scores > 0 were 90.5 % and 94.9 % in experimental and control groups respectively (Relative Risk = 0.95, 95 %CI 0.87-1.04; p = 0.294).Multivariable analysis, controlled for age, diabetes, BMI and smoking exposure, showed a risk reduction of RTOG > 0 of 38 % (HR = 0.62 95 %CI 0.49-0.96, p = 0.028), and a risk reduction of RTOG > 1 of 33 % (HR = 0.67 95 %CI 0.26-1.76, p = 0.420) in the experimental group.The median time to recovery from RTOG grade > 0 toxicity was 17 and 32 days for experimental and control groups, respectively (p = 0.027). At multivariable analysis, time to recovery was 38 % faster in the experimental group (HR = 1.38 95 %CI (0.99-1.93) p = 0.059). Conclusions: Although the study did not demonstrate a statistically significant reduction in RTOG > 2 skin toxicity, there was evidence of a reduction in the rate of skin toxicity and an improvement in time to recovery. The device was well tolerated by patients.
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