A Novel Skin Barrier Protectant for Acute Radiodermatitis (CASP-ORL)

Evaluating the Effectiveness of a Novel Skin Barrier Protectant in the Prevention and Management of Acute Radiodermatitis in Patients With Head and Neck Cancer: a Prospective Cohort Study With Historical Controls

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.

Study Overview

• Status: Withdrawn
• Conditions: Skin Diseases; Head and Neck Cancer; Radiation Toxicity; Radiodermatitis; Radiation Dermatitis
• Intervention / Treatment: Device: Cavilon Advanced Skin Protectant

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Limburg
    • Genk, Limburg, Belgium, 3600
      • Ziekenhuis Oost-Limburg
    • Hasselt, Limburg, Belgium, 3500
      • Jessa Ziekenhuis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 98 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Cavilon Advanced Skin Protectant; Cavilon Advanced Skin Protectant forms a film barrier intended to protect intact or damaged skin. It is effective in conditions where skin is frequently or continuously exposed to moisture and caustic irritants such as feces, digestive fluids, wound drainage and urine. Cavilon Advanced Skin Protectant also can be used in areas exposed to friction and shear from bedding, clothing, shoes or any other material that would rub against the skin. The skin barrier protectant will be applied on the irradiated skin from the third week of radiotherapy until 1 week after the final radiotherapy session.

Device: Cavilon Advanced Skin Protectant; 3M™ Cavilon™ Advanced Skin Protectant is a polymeric-cyanoacrylate solution intended for the protection of intact or damaged skin. Upon application to skin, the liquid dries rapidly to form a primary long-lasting waterproof, highly durable film barrier. It is elastomeric, adhering to the contours of the skin and providing a uniform film. The film is transparent and possesses good oxygen and moisture vapor permeability. The polymer-cyanoacrylate is dispersed in a non-stinging solvent. The film is colorless, non-cytotoxic and has a low dermatitis potential. The film adheres to dry, moist or wet skin surfaces and remains intact during conditions of continuous or repeated exposure to moisture or caustic irritants. It will wear off the skin and does not require removal.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiodermatitis grading	National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.03	Day 1
Radiodermatitis grading	National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.03	Day 14
Radiodermatitis grading	National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.03	Day 20
Radiodermatitis grading	National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.03	Day 35
Radiodermatitis grading	National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.03	Day 38
Radiodermatitis grading	National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.03	Day 47
Radiodermatitis severity	Radiation-Induced Skin Reaction Assessment Scale (0- 36, with a higher score correlating with a more severe skin reaction)	Day 1
Radiodermatitis severity	Radiation-Induced Skin Reaction Assessment Scale (0- 36, with a higher score correlating with a more severe skin reaction)	Day 14
Radiodermatitis severity	Radiation-Induced Skin Reaction Assessment Scale (0- 36, with a higher score correlating with a more severe skin reaction)	Day 20
Radiodermatitis severity	Radiation-Induced Skin Reaction Assessment Scale (0- 36, with a higher score correlating with a more severe skin reaction)	Day 35
Radiodermatitis severity	Radiation-Induced Skin Reaction Assessment Scale (0- 36, with a higher score correlating with a more severe skin reaction)	Day 38
Radiodermatitis severity	Radiation-Induced Skin Reaction Assessment Scale (0- 36, with a higher score correlating with a more severe skin reaction)	Day 47

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life measurement	Patient's quality of life will be assessed by using Skindex-16	day 1
Quality of life measurement	Patient's quality of life will be assessed by using Skindex-16	day 14
Quality of life measurement	Patient's quality of life will be assessed by using Skindex-16	day 20
Quality of life measurement	Patient's quality of life will be assessed by using Skindex-16	day 35
Quality of life measurement	Patient's quality of life will be assessed by using Skindex-16	day 38
Quality of life measurement	Patient's quality of life will be assessed by using Skindex-16	day 47
General satisfaction	Patients' general satisfaction with the skin barrier will be evaluated by using a self-developed questionnaire	Day 35
General satisfaction	Patients' general satisfaction with the skin barrier will be evaluated by using a self-developed questionnaire	day 38
General satisfaction	Patients' general satisfaction with the skin barrier will be evaluated by using a self-developed questionnaire	day 47

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical photograph	A clinical photograph of the treatment area will be taken	day 1
Clinical photograph	A clinical photograph of the treatment area will be taken	day 14
Clinical photograph	A clinical photograph of the treatment area will be taken	day 20
Clinical photograph	A clinical photograph of the treatment area will be taken	day 35
Clinical photograph	A clinical photograph of the treatment area will be taken	day 38
Clinical photograph	A clinical photograph of the treatment area will be taken	day 47
Personal and medical information	Patient's personal and medical information will be gathered via a patient questionnaire and the patient's medical file	day 1

Collaborators and Investigators

• Sponsor: Jessa Hospital
• Investigators: Principal Investigator: Annelies Maes, MD, Limburgs Oncologisch Centrum

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Anticipated): September 1, 2021
• Study Completion (Anticipated): October 1, 2021

Study Registration Dates

• First Submitted: October 8, 2020
• First Submitted That Met QC Criteria: October 15, 2020
• First Posted (Actual): October 20, 2020

Study Record Updates

• Last Update Posted (Actual): November 3, 2021
• Last Update Submitted That Met QC Criteria: October 27, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Wounds and Injuries; Radiation Injuries; Head and Neck Neoplasms; Dermatitis; Skin Diseases; Radiodermatitis; Physiological Effects of Drugs; Protective Agents
• Other Study ID Numbers: 20.17-ONCO20.04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No