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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
Jules Bordet Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Radiodermatitis focused on measuring Radiodermatitis, Mepitel film, Inguinal fold, Radiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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).

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

    First Posted
    November 2, 2020
    Last Updated
    November 2, 2020
    Sponsor
    Jules Bordet Institute
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    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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