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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Radiation Toxicity; Radiodermatitis; Radiotherapy Side Effect
• Intervention / Treatment: Other: Flamigel®; Device: Mepitel® film

• Study Type: Interventional
• Enrollment (Anticipated): 35
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Gitte Van de Ven, MSc; Phone Number: +32 02 541 3882; Email: gitte.vandeven@bordet.be
• Study Contact Backup: Name: Clémence Al Wardi, PhD; Phone Number: +32 02 541 3981; Email: clemence.alwardi@bordet.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control arm	Other: Flamigel®; The control arm will be treated according to the standard of care.
Experimental: Interventional arm	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevention of grade 2.5 RTOG radiodermatitis	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.	Post 25 sessions

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to radiodermatitis apparition	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.	At the end of treatment
Healing time	To analyze the time that the patchy moist desquamation takes to heal and to evaluate if the Mepitel® film group can heal faster.	3 months post treatment

Collaborators and Investigators

• Sponsor: Jules Bordet Institute

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2021
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): January 1, 2025

Study Registration Dates

• First Submitted: November 2, 2020
• First Submitted That Met QC Criteria: November 2, 2020
• First Posted (Actual): November 5, 2020

Study Record Updates

• Last Update Posted (Actual): November 5, 2020
• Last Update Submitted That Met QC Criteria: November 2, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Radiotherapy; Radiodermatitis; Mepitel film; Inguinal fold
• Additional Relevant MeSH Terms: Skin Diseases; Wounds and Injuries; Dermatitis; Radiation Injuries; Radiodermatitis
• Other Study ID Numbers: CE3220.

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No