NCT04617730

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. 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. 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. 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
35

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2021

Longer than P75 for phase_1

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 5, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

November 5, 2020

Status Verified

October 1, 2020

Enrollment Period

3 years

First QC Date

November 2, 2020

Last Update Submit

November 2, 2020

Conditions

RadiodermatitisRadiation ToxicityRadiotherapy Side Effect

Keywords

RadiodermatitisMepitel filmInguinal foldRadiotherapy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Time to radiodermatitis apparition

    At the end of treatment

  • Healing time

    3 months post treatment

Study Arms (2)

Control arm

ACTIVE COMPARATOR
Other: Flamigel®

Interventional arm

EXPERIMENTAL
Device: Mepitel® film

Interventions

Mepitel® filmDEVICE

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.

Interventional arm
Flamigel®OTHER

The control arm will be treated according to the standard of care.

Control arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with external beam radiotherapy of the bilateral inguinal nodal region, with at least 25 fractions of 1.8-2Gy per fraction.

You may not qualify if:

  • Re-irradiation.
  • Pregnancy.
  • Patients under the age of 18.
  • Patients not willing to participate (no informed consent).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

RadiodermatitisRadiation Injuries

Condition Hierarchy (Ancestors)

DermatitisSkin DiseasesSkin and Connective Tissue DiseasesWounds and Injuries

Central Study Contacts

Gitte Van de Ven, MSc

CONTACT

02 541 3882gitte.vandeven@bordet.be

Clémence Al Wardi, PhD

CONTACT

02 541 3981clemence.alwardi@bordet.be

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2020

First Posted

November 5, 2020

Study Start

January 1, 2021

Primary Completion

January 1, 2024

Study Completion

January 1, 2025

Last Updated

November 5, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share