Efficacy of the Mepitel® Film on the Prevention of Radiodermatitis in the Inguinal Fold.
Primary Purpose
Radiodermatitis, Radiation Toxicity, Radiotherapy Side Effect
Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Mepitel® film
Flamigel®
Sponsored by
About this trial
This is an interventional prevention trial for Radiodermatitis focused on measuring Radiodermatitis, Mepitel film, Inguinal fold, Radiotherapy
Eligibility Criteria
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).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control arm
Interventional arm
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT04617730
First Posted
November 2, 2020
Last Updated
November 2, 2020
Sponsor
Jules Bordet Institute
1. Study Identification
Unique Protocol Identification Number
NCT04617730
Brief Title
Efficacy of the Mepitel® Film on the Prevention of Radiodermatitis in the Inguinal Fold.
Official Title
Randomized Trial to Quantify the Efficacy of the Safetac® Product Mepitel® Film on the Prevention of Radiodermatitis in the Inguinal Fold.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2021 (Anticipated)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jules Bordet Institute
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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:
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.
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiodermatitis, Radiation Toxicity, Radiotherapy Side Effect
Keywords
Radiodermatitis, Mepitel film, Inguinal fold, Radiotherapy
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
35 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control arm
Arm Type
Active Comparator
Arm Title
Interventional arm
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Mepitel® film
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Flamigel®
Intervention Description
The control arm will be treated according to the standard of care.
Primary Outcome Measure Information:
Title
Prevention of grade 2.5 RTOG radiodermatitis
Description
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.
Time Frame
Post 25 sessions
Secondary Outcome Measure Information:
Title
Time to radiodermatitis apparition
Description
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.
Time Frame
At the end of treatment
Title
Healing time
Description
To analyze the time that the patchy moist desquamation takes to heal and to evaluate if the Mepitel® film group can heal faster.
Time Frame
3 months post treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gitte Van de Ven, MSc
Phone
02 541 3882
Ext
+32
Email
gitte.vandeven@bordet.be
First Name & Middle Initial & Last Name or Official Title & Degree
Clémence Al Wardi, PhD
Phone
02 541 3981
Ext
+32
Email
clemence.alwardi@bordet.be
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy of the Mepitel® Film on the Prevention of Radiodermatitis in the Inguinal Fold.
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