NCT04617730

Efficacy of the Mepitel® Film on the Prevention of Radiodermatitis in the Inguinal Fold.

Randomized Trial to Quantify the Efficacy of the Safetac® Product Mepitel® Film on the Prevention of Radiodermatitis in the Inguinal Fold.

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Jules Bordet Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim is to quantify the efficiency of the Safetac product Mepitel® Film on the prevention of radiodermatitis for cancer patients treated with external beam radiation therapy near the inguinal fold(s). Previous studies have looked into the differences in skin reactions for Mepitel® Film versus hydro-active colloid gel in breast cancer \[1, 2\] and head and neck cancer \[3\]. In breast cancer, the prevalence of radiation induced dermatitis has strongly decreased due to of modern radiotherapy techniques and fractionation. In the groin, however, this is not the case, and radiation dermatitis remains an important problem. To the best of our knowledge, no previous study has looked into the efficiency of a prophylactic Mepitel® Film protocol in the inguinal fold. The goal of this study is to evaluate whether the Mepitel® Film offers a lower degree of radiation-induced dermatitis compared to hydro-active colloid gel and thereby challenging the gold standard. References: 1. Herst, P., Bennett, N., Sutherland, A., Peszynski, R., Paterson, D. and Jasperse, M. (2014). Prophylactic use of Mepitel Film prevents radiation-induced moist desquamation in an intra-patient randomised controlled clinical trial of 78 breast cancer patients. Radiotherapy and Oncology, 110(1), pp.137-143. 2. Møller, P., Olling, K., Berg, M., Habæk, I., Haislund, B., Iversen, A., Ewertz, M., Lorenzen, E. and Brink, C. (2018). Breast cancer patients report reduced sensitivity and pain using a barrier film during radiotherapy - A Danish intra-patient randomized multicentre study. Technical Innovations \& Patient Support in Radiation Oncology, 7, pp.20-25. 3. Wooding, H., Yan, J., Yuan, L., Chyou, T., Gao, S., Ward, I. and Herst, P. (2018). The effect of Mepitel Film on acute radiation-induced skin reactions in head and neck cancer patients: a feasibility study. The British Journal of Radiology, 91(1081), p.20170298.

Conditions

• Radiodermatitis
• Radiation Toxicity
• Radiotherapy Side Effect

Interventions

Type	Name	Description
DEVICE	Mepitel® film	This study is a comparative study between the standard procedure, which is to prescribe a hydro-active colloidal gel called Flamigel® to be applied to the irradiated area, and the use of Mepitel® Film.
OTHER	Flamigel®	The control arm will be treated according to the standard of care.

Timeline

• Start date: 2021-01-01
• Primary completion: 2024-01-01
• Completion: 2025-01-01
• First posted: 2020-11-05
• Last updated: 2020-11-05