A Novel Skin Barrier Protectant for Acute Radiodermatitis

Head and Neck Cancer Clinical Trial

— CASP-ORL  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04593914
• Other study ID #: 20.17-ONCO20.04
• Status: Withdrawn
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: October 1, 2021

Study information

• Verified date: October 2021
• Source: Jessa Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 1, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Dermatitis
• Head and Neck Cancer
• Head and Neck Neoplasms
• Radiation Dermatitis
• Radiation Toxicity
• Radiodermatitis
• Skin Diseases

Intervention

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.

Locations

Country	Name	City	State
Belgium	Ziekenhuis Oost-Limburg	Genk	Limburg
Belgium	Jessa Ziekenhuis	Hasselt	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Jessa Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Clinical photograph	A clinical photograph of the treatment area will be taken	day 1
Other	Clinical photograph	A clinical photograph of the treatment area will be taken	day 14
Other	Clinical photograph	A clinical photograph of the treatment area will be taken	day 20
Other	Clinical photograph	A clinical photograph of the treatment area will be taken	day 35
Other	Clinical photograph	A clinical photograph of the treatment area will be taken	day 38
Other	Clinical photograph	A clinical photograph of the treatment area will be taken	day 47
Other	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
Primary	Radiodermatitis grading	National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.03	Day 1
Primary	Radiodermatitis grading	National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.03	Day 14
Primary	Radiodermatitis grading	National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.03	Day 20
Primary	Radiodermatitis grading	National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.03	Day 35
Primary	Radiodermatitis grading	National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.03	Day 38
Primary	Radiodermatitis grading	National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.03	Day 47
Primary	Radiodermatitis severity	Radiation-Induced Skin Reaction Assessment Scale (0- 36, with a higher score correlating with a more severe skin reaction)	Day 1
Primary	Radiodermatitis severity	Radiation-Induced Skin Reaction Assessment Scale (0- 36, with a higher score correlating with a more severe skin reaction)	Day 14
Primary	Radiodermatitis severity	Radiation-Induced Skin Reaction Assessment Scale (0- 36, with a higher score correlating with a more severe skin reaction)	Day 20
Primary	Radiodermatitis severity	Radiation-Induced Skin Reaction Assessment Scale (0- 36, with a higher score correlating with a more severe skin reaction)	Day 35
Primary	Radiodermatitis severity	Radiation-Induced Skin Reaction Assessment Scale (0- 36, with a higher score correlating with a more severe skin reaction)	Day 38
Primary	Radiodermatitis severity	Radiation-Induced Skin Reaction Assessment Scale (0- 36, with a higher score correlating with a more severe skin reaction)	Day 47
Secondary	Quality of life measurement	Patient's quality of life will be assessed by using Skindex-16	day 1
Secondary	Quality of life measurement	Patient's quality of life will be assessed by using Skindex-16	day 14
Secondary	Quality of life measurement	Patient's quality of life will be assessed by using Skindex-16	day 20
Secondary	Quality of life measurement	Patient's quality of life will be assessed by using Skindex-16	day 35
Secondary	Quality of life measurement	Patient's quality of life will be assessed by using Skindex-16	day 38
Secondary	Quality of life measurement	Patient's quality of life will be assessed by using Skindex-16	day 47
Secondary	General satisfaction	Patients' general satisfaction with the skin barrier will be evaluated by using a self-developed questionnaire	Day 35
Secondary	General satisfaction	Patients' general satisfaction with the skin barrier will be evaluated by using a self-developed questionnaire	day 38
Secondary	General satisfaction	Patients' general satisfaction with the skin barrier will be evaluated by using a self-developed questionnaire	day 47