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

Free University of Brussels (ULB)

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Radiotherapy Side Effect; Radiation Toxicity; Radiodermatitis

Treatments: Device: Mepitel® film; Other: Flamigel®

Study type: Interventional

Funder types: Other

Identifiers

NCT04617730

CE3220.

Details and patient eligibility

About

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.

Enrollment: 35 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with external beam radiotherapy of the bilateral inguinal nodal region, with at least 25 fractions of 1.8-2Gy per fraction.

Exclusion criteria

• Re-irradiation.
• Pregnancy.
• Patients under the age of 18.
• Patients not willing to participate (no informed consent).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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35 participants in 2 patient groups

Control arm

Active Comparator group

Treatment:

Other: Flamigel®

Interventional arm

Experimental group

Treatment:

Device: Mepitel® film