A Novel Skin Barrier Protectant for Acute Radiodermatitis

NCT04593914 | Withdrawn

• 1 other identifier: 20.17-ONCO20.04
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Radiodermatitis; Radiation Toxicity; Radiation Dermatitis; Skin Diseases; Head and Neck Cancer

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (9)

• Quality of life measurement

  day 1

• Quality of life measurement

  day 14

• Quality of life measurement

  day 20

• Quality of life measurement

  day 35

• Quality of life measurement

  day 38

Other Outcomes (7)

• Clinical photograph

  day 1

• Clinical photograph

  day 14

• Clinical photograph

  day 20

Study Arms (1)

Cavilon Advanced Skin Protectant

EXPERIMENTAL

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

Interventions

Cavilon Advanced Skin Protectant DEVICE

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.

Cavilon Advanced Skin Protectant

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jessa Hospital: lead

Study Sites (2)

Ziekenhuis Oost-Limburg

Genk, Limburg, 3600, Belgium

Location

Jessa Ziekenhuis

Hasselt, Limburg, 3500, Belgium

Location

MeSH Terms

Conditions

Radiodermatitis; Radiation Injuries; Skin Diseases; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Dermatitis; Skin and Connective Tissue Diseases; Wounds and Injuries; Neoplasms by Site; Neoplasms

Study Officials

• Annelies Maes, MD

  Limburgs Oncologisch Centrum

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2020
• First Posted: October 20, 2020
• Study Start: September 1, 2020
• Primary Completion: September 1, 2021
• Study Completion: October 1, 2021
• Last Updated: November 3, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2)