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

Primary Purpose

Radiodermatitis, Radiation Toxicity, Radiation Dermatitis

Status
Withdrawn
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Cavilon Advanced Skin Protectant
Sponsored by
Jessa Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Radiodermatitis

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ziekenhuis Oost-Limburg
  • Jessa Ziekenhuis

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cavilon Advanced Skin Protectant

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 8, 2020
Last Updated
October 27, 2021
Sponsor
Jessa Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04593914
Brief Title
A Novel Skin Barrier Protectant for Acute Radiodermatitis
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Covid-19
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
September 1, 2021 (Anticipated)
Study Completion Date
October 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jessa Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiodermatitis, Radiation Toxicity, Radiation Dermatitis, Skin Diseases, Head and Neck Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cavilon Advanced Skin Protectant
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Cavilon Advanced Skin Protectant
Intervention Description
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.
Primary Outcome Measure Information:
Title
Radiodermatitis grading
Description
National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.03
Time Frame
Day 1
Title
Radiodermatitis grading
Description
National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.03
Time Frame
Day 14
Title
Radiodermatitis grading
Description
National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.03
Time Frame
Day 20
Title
Radiodermatitis grading
Description
National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.03
Time Frame
Day 35
Title
Radiodermatitis grading
Description
National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.03
Time Frame
Day 38
Title
Radiodermatitis grading
Description
National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.03
Time Frame
Day 47
Title
Radiodermatitis severity
Description
Radiation-Induced Skin Reaction Assessment Scale (0- 36, with a higher score correlating with a more severe skin reaction)
Time Frame
Day 1
Title
Radiodermatitis severity
Description
Radiation-Induced Skin Reaction Assessment Scale (0- 36, with a higher score correlating with a more severe skin reaction)
Time Frame
Day 14
Title
Radiodermatitis severity
Description
Radiation-Induced Skin Reaction Assessment Scale (0- 36, with a higher score correlating with a more severe skin reaction)
Time Frame
Day 20
Title
Radiodermatitis severity
Description
Radiation-Induced Skin Reaction Assessment Scale (0- 36, with a higher score correlating with a more severe skin reaction)
Time Frame
Day 35
Title
Radiodermatitis severity
Description
Radiation-Induced Skin Reaction Assessment Scale (0- 36, with a higher score correlating with a more severe skin reaction)
Time Frame
Day 38
Title
Radiodermatitis severity
Description
Radiation-Induced Skin Reaction Assessment Scale (0- 36, with a higher score correlating with a more severe skin reaction)
Time Frame
Day 47
Secondary Outcome Measure Information:
Title
Quality of life measurement
Description
Patient's quality of life will be assessed by using Skindex-16
Time Frame
day 1
Title
Quality of life measurement
Description
Patient's quality of life will be assessed by using Skindex-16
Time Frame
day 14
Title
Quality of life measurement
Description
Patient's quality of life will be assessed by using Skindex-16
Time Frame
day 20
Title
Quality of life measurement
Description
Patient's quality of life will be assessed by using Skindex-16
Time Frame
day 35
Title
Quality of life measurement
Description
Patient's quality of life will be assessed by using Skindex-16
Time Frame
day 38
Title
Quality of life measurement
Description
Patient's quality of life will be assessed by using Skindex-16
Time Frame
day 47
Title
General satisfaction
Description
Patients' general satisfaction with the skin barrier will be evaluated by using a self-developed questionnaire
Time Frame
Day 35
Title
General satisfaction
Description
Patients' general satisfaction with the skin barrier will be evaluated by using a self-developed questionnaire
Time Frame
day 38
Title
General satisfaction
Description
Patients' general satisfaction with the skin barrier will be evaluated by using a self-developed questionnaire
Time Frame
day 47
Other Pre-specified Outcome Measures:
Title
Clinical photograph
Description
A clinical photograph of the treatment area will be taken
Time Frame
day 1
Title
Clinical photograph
Description
A clinical photograph of the treatment area will be taken
Time Frame
day 14
Title
Clinical photograph
Description
A clinical photograph of the treatment area will be taken
Time Frame
day 20
Title
Clinical photograph
Description
A clinical photograph of the treatment area will be taken
Time Frame
day 35
Title
Clinical photograph
Description
A clinical photograph of the treatment area will be taken
Time Frame
day 38
Title
Clinical photograph
Description
A clinical photograph of the treatment area will be taken
Time Frame
day 47
Title
Personal and medical information
Description
Patient's personal and medical information will be gathered via a patient questionnaire and the patient's medical file
Time Frame
day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annelies Maes, MD
Organizational Affiliation
Limburgs Oncologisch Centrum
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ziekenhuis Oost-Limburg
City
Genk
State/Province
Limburg
ZIP/Postal Code
3600
Country
Belgium
Facility Name
Jessa Ziekenhuis
City
Hasselt
State/Province
Limburg
ZIP/Postal Code
3500
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

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A Novel Skin Barrier Protectant for Acute Radiodermatitis

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