RadiodermatitisCASP-ORLNCT04593914
A Novel Skin Barrier Protectant for Acute Radiodermatitis
A study testing Cavilon Advanced Skin Protectant in people with Radiodermatitis and Radiation Toxicity, run by Jessa Hospital at 2 sites in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Radiodermatitis, Radiation Toxicity, Radiation Dermatitis
- What is being tested?
- Cavilon Advanced Skin Protectant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesBelgium
- Study dates
- 1 Sep 2020to 1 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
Ziekenhuis Oost-Limburg
Genk, Limburg, 3600
Jessa Ziekenhuis
Hasselt, Limburg, 3500
About this study
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
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
- Being tested
- Cavilon Advanced Skin Protectant
- Medical subject headings
- Radiodermatitis, Radiation Injuries, Skin Diseases, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cavilon Advanced Skin ProtectantDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Cavilon Advanced Skin Protectant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiodermatitis grading
National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.03
Measured: Day 1
Radiodermatitis grading
National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.03
Measured: Day 14
Radiodermatitis grading
National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.03
Measured: Day 20
Radiodermatitis grading
National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.03
Measured: Day 35
Radiodermatitis grading
National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.03
Measured: Day 38
Radiodermatitis grading
National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.03
Measured: Day 47
Radiodermatitis severity
Radiation-Induced Skin Reaction Assessment Scale (0- 36, with a higher score correlating with a more severe skin reaction)
Measured: Day 1
Radiodermatitis severity
Radiation-Induced Skin Reaction Assessment Scale (0- 36, with a higher score correlating with a more severe skin reaction)
Measured: Day 14
Radiodermatitis severity
Radiation-Induced Skin Reaction Assessment Scale (0- 36, with a higher score correlating with a more severe skin reaction)
Measured: Day 20
Radiodermatitis severity
Radiation-Induced Skin Reaction Assessment Scale (0- 36, with a higher score correlating with a more severe skin reaction)
Measured: Day 35
Radiodermatitis severity
Radiation-Induced Skin Reaction Assessment Scale (0- 36, with a higher score correlating with a more severe skin reaction)
Measured: Day 38
Radiodermatitis severity
Radiation-Induced Skin Reaction Assessment Scale (0- 36, with a higher score correlating with a more severe skin reaction)
Measured: Day 47
Secondary outcomes (9)
Quality of life measurement
Patient's quality of life will be assessed by using Skindex-16
Measured: day 1
Quality of life measurement
Patient's quality of life will be assessed by using Skindex-16
Measured: day 14
Quality of life measurement
Patient's quality of life will be assessed by using Skindex-16
Measured: day 20
Quality of life measurement
Patient's quality of life will be assessed by using Skindex-16
Measured: day 35
Quality of life measurement
Patient's quality of life will be assessed by using Skindex-16
Measured: day 38
Quality of life measurement
Patient's quality of life will be assessed by using Skindex-16
Measured: day 47
General satisfaction
Patients' general satisfaction with the skin barrier will be evaluated by using a self-developed questionnaire
Measured: Day 35
General satisfaction
Patients' general satisfaction with the skin barrier will be evaluated by using a self-developed questionnaire
Measured: day 38
General satisfaction
Patients' general satisfaction with the skin barrier will be evaluated by using a self-developed questionnaire
Measured: day 47
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start1 Sep 2020
- Primary completion1 Sep 2021 (estimated)
- Study completion1 Oct 2021 (estimated)
Why it stopped: Covid-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RadiodermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jessa Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Annelies Maes, MD, Principal investigator, Limburgs Oncologisch Centrum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04593914
- Sponsor's protocol ID
- 20.17-ONCO20.04
- Acronym
- CASP-ORL
- Status last verified
- Oct 2021
- First submitted
- 8 Oct 2020
- Last updated
- 3 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04593914
- Acronym / sponsor ID
- CASP-ORL / 20.17-ONCO20.04
- Conditions
- Radiodermatitis, Radiation Toxicity, Radiation Dermatitis, Skin Diseases, Head and Neck Cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Covid-19
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Jessa HospitalUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 1 Oct 2021 (estimated)
- First posted
- 20 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cavilon Advanced Skin Protectant | Experimental | Device: Cavilon Advanced Skin ProtectantCavilon 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cavilon Advanced Skin Protectant3M™ 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. | Device | Cavilon Advanced Skin Protectant |
Primary outcome
Radiodermatitis grading
Time frame: Day 1
National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.03
Radiodermatitis grading
Time frame: Day 14
National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.03
Radiodermatitis grading
Time frame: Day 20
National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.03
Radiodermatitis grading
Time frame: Day 35
National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.03
Radiodermatitis grading
Time frame: Day 38
National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.03
Radiodermatitis grading
Time frame: Day 47
National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.03
Radiodermatitis severity
Time frame: Day 1
Radiation-Induced Skin Reaction Assessment Scale (0- 36, with a higher score correlating with a more severe skin reaction)
Radiodermatitis severity
Time frame: Day 14
Radiation-Induced Skin Reaction Assessment Scale (0- 36, with a higher score correlating with a more severe skin reaction)
Radiodermatitis severity
Time frame: Day 20
Radiation-Induced Skin Reaction Assessment Scale (0- 36, with a higher score correlating with a more severe skin reaction)
Radiodermatitis severity
Time frame: Day 35
Radiation-Induced Skin Reaction Assessment Scale (0- 36, with a higher score correlating with a more severe skin reaction)
Radiodermatitis severity
Time frame: Day 38
Radiation-Induced Skin Reaction Assessment Scale (0- 36, with a higher score correlating with a more severe skin reaction)
Radiodermatitis severity
Time frame: Day 47
Radiation-Induced Skin Reaction Assessment Scale (0- 36, with a higher score correlating with a more severe skin reaction)
9 secondary outcomes
Quality of life measurement
Time frame: day 1
Quality of life measurement
Time frame: day 14
Quality of life measurement
Time frame: day 20
Quality of life measurement
Time frame: day 35
Quality of life measurement
Time frame: day 38
Quality of life measurement
Time frame: day 47
General satisfaction
Time frame: Day 35
General satisfaction
Time frame: day 38
General satisfaction
Time frame: day 47
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annelies Maes, MD principal investigator
Limburgs Oncologisch Centrum
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cavilon Advanced Skin Protectant in people with Radiodermatitis and Radiation Toxicity, run by Jessa Hospital at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiodermatitis grading (time frame: Day 1). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2021.