RadiodermatitisNCT04067310
Study Using Spray Skin Protector Versus Conventional Treatment to Prevent Acute Radiodermatitis.
A study testing Spray skin protector and moisturizer Dnativ Revita derm in people with Radiodermatitis and Injury, Radiation, run by Instituto Nacional de Cancer, Brazil at 1 site in Brazil.
Trial summary
This is a randomized, open-label, single-institution trial designed to evaluate the effectiveness of a spray skin protector in preventing moist desquamation caused by radiotherapy treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiodermatitis, Injury, Radiation
- What is being tested?
- Spray skin protector and moisturizer Dnativ Revita derm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteBrazil
- Study dates
- 16 Dec 2020to 20 Jan 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria: patients with anal and rectal cancer with indication for radiotherapy and conventional fractionation of treatment in a linear accelerator; age > or = 18 years; no previous history of radiotherapy in the same field/site of treatment (reirradiation).
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Exclusion Criteria:patients with pre-existing irradiated dermatitis, which makes skin assessment difficult; previous report of allergic reaction to any of the products used in the research.
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Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Open-label Study Using Spray Skin Protector Versus Conventional Treatment to Prevent Acute Radiodermatitis in Patients With Anal and Rectal Canal Cancer.
This is a randomized, open-label, single-institution trial designed to evaluate the effectiveness of a spray skin protector in preventing moist desquamation caused by radiotherapy treatment.
This technology, spray skin protection, depending on the manufacturer, is primarily intended to prevent or reduce contact dermatitis. However, this study will be evaluated for use in preventing moist desquamation caused by ionizing radiation. The comparing agent will be a moisturizer, agreed upon at the local Institution of the study for use in the prevention of radiodermatitis. As secondary objectives: describe adverse events, diarrhea, pain and pruritus.
The study will be conducted at the radiotherapy outpatient clinic of the Cancer Hospital I (HCI) of National Cancer Institute (INCA) in Brazil.
Read the detailed description
The hypotheses are:
Null (Ho): The incidence of moist desquamation with the spray skin protector is greater than or equal to the incidence of moist desquamation in the control group.
Alternative (H1): The incidence of moist desquamation with the spray skin protector is lower than the incidence of moist desquamation in the control group.
The evaluation of the skin of the participants will be weekly, with blinding of this professional. For the evaluation of secondary objectives, adverse events will be applied in the assessment scales of diarrhea, pruritus and pain by the CTCAE version 5.0; and the burning or burning sensation will be recorded only.
- Conditions
- Radiodermatitis, Injury, Radiation
- Being tested
- Spray skin protector, moisturizer Dnativ Revita derm
- Keywords
- barrier film, spray skin protection, liquid-film, barrier product
- Medical subject headings
- Radiodermatitis, Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spray skin protectorOther
Also called barrier film to prevent radiodermatitis
Patients will use spray skin protector treatment from the randomization day until the last day of radiotherapy.
moisturizer Dnativ Revita dermOther
Also called conventional treatment to prevent radiodermatitis
Patients will use conventional preventive treatment from the randomization day until the last day of radiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Group Experimental | Experimental | Participants who will use the spray skin protector Receives: Other: Spray skin protector |
| Group control | Active comparator | Participants who will use moisturizer Dnativ Revita Derm. Receives: Other: moisturizer Dnativ Revita derm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Categorized by RTOG Grading Scale
RTOG ACUTE Radiation Morbidity - Tissue: Skin
- Grade 1: Follicular, faint or dull erythema / epilation / dry desquamation / decreased sweating;
- Grade 2: Tender or bright erythema, patchy moist desquamation / moderate edema;
- Grade 3: Confluent, moist desquamation other than skin folds, pitting edema;
- Grade 4: Ulceration, hemorrhage, necrosis.
Measured: From the first day of radiotherapy up to eight weeks
Secondary outcomes (1)
Adverse Events
Occurrence of adverse events after the beginning of radiotherapy
Measured: From the first day of radiotherapy up to eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2019
- Study start16 Dec 2020
- Primary completion30 Dec 2022
- Study completion20 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- After signing the Informed Consent Form, randomization will be carried out in two groups: Experimental, which will use the skin protector in spray and control, which will use the moisturizer Dnativ Revita Derm.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Cancer, Brazil
- Sponsor type
- Other government
- Collaborators
- Rio de Janeiro State Research Supporting Foundation (FAPERJ)
- Responsible party
- Principal investigator, Fabiana Verdan Simões, Instituto Nacional de Cancer, Brazil
- Investigators
- Fabiana V Simões, Principal investigator, Universidade Federal do Rio de Janeiro (UFRJ)Rafael C Silva, Principal investigator, Universidade Federal do Rio de Janeiro (UFRJ)Beatriz G R B Oliveira, Principal investigator, Universidade Federal Fluminense (UFF)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04067310
- Sponsor's protocol ID
- PROT
- Status last verified
- Oct 2024
- First submitted
- 20 Aug 2019
- Last updated
- 9 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Open-label Study Using Spray Skin Protector Versus Conventional Treatment to Prevent Acute Radiodermatitis in Patients With Anal and Rectal Canal Cancer.
- ClinicalTrials.gov ID
- NCT04067310
- Acronym / sponsor ID
- PROT
- Conditions
- Radiodermatitis, Injury, Radiation
- Keywords
- barrier film, spray skin protection, liquid-film, barrier product
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Instituto Nacional de Cancer, BrazilOther government
- Collaborators
- Rio de Janeiro State Research Supporting Foundation (FAPERJ)
- Study start
- 16 Dec 2020 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 20 Jan 2023 (actual)
- First posted
- 26 Aug 2019 (actual)
- Results
- Posted 9 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, open-label, single-institution trial designed to evaluate the effectiveness of a spray skin protector in preventing moist desquamation caused by radiotherapy treatment.
This technology, spray skin protection, depending on the manufacturer, is primarily intended to prevent or reduce contact dermatitis. However, this study will be evaluated for use in preventing moist desquamation caused by ionizing radiation. The comparing agent will be a moisturizer, agreed upon at the local Institution of the study for use in the prevention of radiodermatitis. As secondary objectives: describe adverse events, diarrhea, pain and pruritus.
The study will be conducted at the radiotherapy outpatient clinic of the Cancer Hospital I (HCI) of National Cancer Institute (INCA) in Brazil.
Detailed description
The hypotheses are:
Null (Ho): The incidence of moist desquamation with the spray skin protector is greater than or equal to the incidence of moist desquamation in the control group.
Alternative (H1): The incidence of moist desquamation with the spray skin protector is lower than the incidence of moist desquamation in the control group.
The evaluation of the skin of the participants will be weekly, with blinding of this professional. For the evaluation of secondary objectives, adverse events will be applied in the assessment scales of diarrhea, pruritus and pain by the CTCAE version 5.0; and the burning or burning sensation will be recorded only.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- After signing the Informed Consent Form, randomization will be carried out in two groups: Experimental, which will use the skin protector in spray and control, which will use the moisturizer Dnativ Revita Derm.
| Arm | Type | Receives |
|---|---|---|
| Group Experimental | Experimental | Other: Spray skin protectorParticipants who will use the spray skin protector |
| Group control | Active comparator | Other: moisturizer Dnativ Revita dermParticipants who will use moisturizer Dnativ Revita Derm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Spray skin protectorAlso: barrier film to prevent radiodermatitisPatients will use spray skin protector treatment from the randomization day until the last day of radiotherapy. | Other | Group Experimental |
| moisturizer Dnativ Revita dermAlso: conventional treatment to prevent radiodermatitisPatients will use conventional preventive treatment from the randomization day until the last day of radiotherapy. | Other | Group control |
Primary outcome
Number of Participants Categorized by RTOG Grading Scale
Time frame: From the first day of radiotherapy up to eight weeks
RTOG ACUTE Radiation Morbidity - Tissue: Skin * Grade 1: Follicular, faint or dull erythema / epilation / dry desquamation / decreased sweating; * Grade 2: Tender or bright erythema, patchy moist desquamation / moderate edema; * Grade 3: Confluent, moist desquamation other than skin folds, pitting edema; * Grade 4: Ulceration, hemorrhage, necrosis.
1 secondary outcome
Adverse Events
Time frame: From the first day of radiotherapy up to eight weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Radiodermatitis
RecruitingEarly Phase 1
Adapalene Gel for Acute Radiation-Induced Skin Injury
Radiation Dermatitis
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Bacterial Decolonization to Prevent Severe Radiation Dermatitis in Head and Neck Squamous Cell Carcinoma
HNSCC
Active, not recruiting
Photobiomodulation for the Prevention of Radiation Induced Oral Mucositis
Mucositis Oral, Head and Neck Cancer
RecruitingObservational study
Health Oriented Protocol for Epidermal Radiodermatitis
Head and Neck Cancer, Pelvic Cancer
RecruitingPhase 1
Using Silverlon® for Head and Neck Patients With Tracheostomies
Head and Neck Cancer, Radiation Dermatitis Acute
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.
Fabiana V Simões principal investigator
Universidade Federal do Rio de Janeiro (UFRJ)
Rafael C Silva principal investigator
Universidade Federal do Rio de Janeiro (UFRJ)
Beatriz G R B Oliveira principal investigator
Universidade Federal Fluminense (UFF)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spray skin protector and moisturizer Dnativ Revita derm in people with Radiodermatitis and Injury, Radiation, run by Instituto Nacional de Cancer, Brazil at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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?
Yes. Results are posted in the registry (first posted 9 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Categorized by RTOG Grading Scale (time frame: From the first day of radiotherapy up to eight weeks). 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 9 Dec 2024.