A Novel Skin Barrier Protectant for Acute Radiodermatitis

Not Applicable

Withdrawn

• Conditions: Head and Neck Cancer; Skin Diseases; Radiodermatitis; Radiation Toxicity; Radiation Dermatitis

• Registration Number: NCT04593914
• Lead Sponsor: Jessa Hospital

Brief Summary

Acute radiodermatitis (ARD) is a distressing and painful skin reaction that occurs in 95% of the patients undergoing radiotherapy (RT). To date, there is still no general approved guideline for the prevention and management of acute radiodermatitis. The 3M™ Cavilon™ Advanced Skin Protectant is a novel skin barrier protectant that acts as a physical barrier against abrasion, moisture, and irritants. Moreover, it enables an environment for wound healing. The aim of this study is to evaluate the effectiveness of 3M™ Cavilon™ Advanced Skin Protectant in the prevention and management of ARD in patients with head and neck cancer.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-01
• Study First Submitted: 2020-10-08
• Study First Submitted QC: 2020-10-15
• Study First Posted: 2020-10-20
• Primary Completion: 2021-09-01
• Status Verified: 2021-10
• Study Completion: 2021-10-01
• Last Update Submitted: 2021-10-27
• Last Update Posted: 2021-11-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Diagnosis of head and neck squamous cell carcinomas (HNSCC) starting in the lip, salivary gland, oral cavity (mouth), nasal cavity (inside the nose), paranasal sinuses, pharynx, or larynx.
• Scheduled for bilateral neck radiotherapy (>60 Gy) with or without concomitant chemotherapy either as primary or as post-operative treatment to the head and neck region
• Age ≥ 18 years
• Able to comply to the study protocol
• Able to sign written informed consent
• Signed written informed consent

Exclusion Criteria

• Previous irradiation to the head and/or neck region
• Metastatic disease
• Patients with pre-existing skin rash, ulceration or open wound in the treatment area
• Patients with known allergic and other systemic skin diseases even when not directly affecting irradiated fields
• Substance abuse patients or patients with medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results as judged by the investigator
• Any condition that is unstable or could affect the safety of the patient and their compliance in the study as judged by the investigator
• Patients using high doses of non-steroidal anti-inflammatory drugs
• Patients allergic to the ingredients of the 3M™ Cavilon™ Advanced Skin Protectant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Radiodermatitis grading	Day 47	National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.03
Radiodermatitis severity	Day 47	Radiation-Induced Skin Reaction Assessment Scale (0- 36, with a higher score correlating with a more severe skin reaction)

Secondary Outcome Measures

Name	Time	Method
General satisfaction	day 47	Patients' general satisfaction with the skin barrier will be evaluated by using a self-developed questionnaire
Quality of life measurement	day 47	Patient's quality of life will be assessed by using Skindex-16

Trial Locations

Locations (2)

Ziekenhuis Oost-Limburg; 🇧🇪 Genk, Limburg, Belgium

Jessa Ziekenhuis; 🇧🇪 Hasselt, Limburg, Belgium