Clinical trial NCT04617730: 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
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Radiodermatitis
Radiation Toxicity
Radiotherapy Side Effect
Keywords: Radiodermatitis
Mepitel film
Inguinal fold
Radiotherapy
Lead sponsor: Jules Bordet Institute
Sponsor class: OTHER
First posted: 2020-11-05
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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).

Primary outcomes:
measure: Prevention of grade 2.5 RTOG radiodermatitis
timeFrame: Post 25 sessions
Secondary outcomes:
measure: Time to radiodermatitis apparition
timeFrame: At the end of treatment
measure: Healing time
timeFrame: 3 months post treatment
Other outcomes:
Locations:
Study officials:
References: