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

Phase 1

Not yet recruiting

• Conditions: Radiotherapy Side Effect; Radiodermatitis; Radiation Toxicity
• Interventions: Other: Flamigel®; Device: Mepitel® film

• Registration Number: NCT04617730
• Lead Sponsor: Jules Bordet Institute

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-10
• Study First Submitted: 2020-11-02
• Study First Submitted QC: 2020-11-02
• Last Update Submitted: 2020-11-02
• Study First Posted: 2020-11-05
• Last Update Posted: 2020-11-05
• Study Start: 2021-01-01
• Primary Completion: 2024-01-01
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 35

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control arm	Flamigel®	-
Interventional arm	Mepitel® film	-

Primary Outcome Measures

Name	Time	Method
Prevention of grade 2.5 RTOG radiodermatitis	Post 25 sessions	To evaluate and quantify the influence of the Mepitel® Film dressing on the prevention of patchy moist desquamation (grade 2.5 RTOG) radiodermatitis in the inguinal fold.

Secondary Outcome Measures

Name	Time	Method
Time to radiodermatitis apparition	At the end of treatment	To analyze the time it takes for the patchy moist desquamation (grade 2.5 RTOG) to appear and to evaluate whether it occurs later in the Mepitel® Film group.
Healing time	3 months post treatment	To analyze the time that the patchy moist desquamation takes to heal and to evaluate if the Mepitel® film group can heal faster.