NCT04617730

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

Status unknown Phase 1, PHASE2 Last updated 5 November 2020

What this trial tests

Phase 1, PHASE2 trial testing Mepitel® film in Radiodermatitis in 35 participants. Status unknown.

Timeline

1 January 2021

Primary endpoint
1 January 2024

1 January 2025

Quick facts

Lead sponsor	Jules Bordet Institute
Phase	Phase 1, PHASE2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	35
Start date	1 January 2021
Primary completion	1 January 2024
Estimated completion	1 January 2025

Drugs / interventions tested

• Mepitel® film
• Flamigel®

Conditions studied

• Radiodermatitis — all drugs for Radiodermatitis →
• Radiation Toxicity — all drugs for Radiation Toxicity →
• Radiotherapy Side Effect — all drugs for Radiotherapy Side Effect →

Sponsor

Jules Bordet Institute

Who can join

18 and older, any sex, with Radiodermatitis or Radiation Toxicity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.