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| Name | Class |
|---|---|
| Rio de Janeiro State Research Supporting Foundation (FAPERJ) | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group Experimental | Experimental | Participants who will use the spray skin protector |
|
| Group control | Active Comparator | Participants who will use moisturizer Dnativ Revita Derm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spray skin protector | Other | Patients will use spray skin protector treatment from the randomization day until the last day of radiotherapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Categorized by RTOG Grading Scale | RTOG ACUTE Radiation Morbidity - Tissue: Skin
| From the first day of radiotherapy up to eight weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Occurrence of adverse events after the beginning of radiotherapy | From the first day of radiotherapy up to eight weeks |
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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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| Name | Affiliation | Role |
|---|---|---|
| Fabiana V Simões | Universidade Federal do Rio de Janeiro (UFRJ) | Principal Investigator |
| Rafael C Silva | Universidade Federal do Rio de Janeiro (UFRJ) | Principal Investigator |
| Beatriz G R B Oliveira | Universidade Federal Fluminense (UFF) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| INCA Research Center | Rio de Janeiro | Rio de Janeiro | 20231092 | Brazil |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group Experimental | Participants who used the skin protector spray Skin protector spray: Patients used skin protector spray treatment from the randomization day until the last day of radiotherapy. |
| FG001 | Group Control | Participants who will use moisturizer Dnativ Revita Derm. Moisturizer Dnativ Revita derm: Patients used conventional preventive treatment from the randomization day until the last day of radiotherapy. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group Experimental | Intention to treat |
| BG001 | Group Control | Intention to treat |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Categorized by RTOG Grading Scale | RTOG ACUTE Radiation Morbidity - Tissue: Skin
| Patients with anal canal or rectum cancer with indication for RT and conventional treatment fractionation in Linear Accelerator (< 250cGy/day); 18+ years old; no previous history of radiotherapy in the same treatment field/site (reirradiation); with no preexisting dermatitis at the irradiated site that would make it difficult to assess the skin; and no previous report of allergic reaction to any products used in the research. | Posted | Count of Participants | Participants | From the first day of radiotherapy up to eight weeks |
|
From the first day of radiotherapy up to eight weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group Experimental | Maximum RTOG grade - Intention to Treat: Grade 1 - 12 (35.3%) Grade 2 - 11 (32.4%) Grade 3 - 10 (29.4%) Grade 4 - 1 (2.9%) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lung infection | Infections and infestations | CTCAE (5.0) | Systematic Assessment | Severe Acute Respiratory Syndrome caused by SRAS-CoV-2 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Discomfort | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
The small sample size was a methodological limitation. When the COVID-19 pandemic emerged, the institution reduced the number of vacancies in the regulation system for the radiotherapy outpatient clinic of the HCI-INCA. Other factor that hindered attracting participants was the opening of new vacancies for radiotherapy in other institutions that had been closed until then.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Instituto Nacional do Câncer | +552132076549 | cecilia.silva@inca.gov.br |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 19, 2019 | Oct 30, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011855 | Radiodermatitis |
| D011832 | Radiation Injuries |
| ID | Term |
|---|---|
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D014947 | Wounds and Injuries |
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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.
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Blinding will be in skin evaluation and statistical analysis.
| moisturizer Dnativ Revita derm | Other | Patients will use conventional preventive treatment from the randomization day until the last day of radiotherapy. |
|
|
| Withdrawal by Subject |
|
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Maximum RTOG grade - Intention to Treat: Grade 1 - 12 (35.3%) Grade 2 - 11 (32.4%) Grade 3 - 10 (29.4%) Grade 4 - 1 (2.9%) |
| OG001 | Group Control | Maximum RTOG grade - Intention to Treat: Grade 1 - 6 (20.7%) Grade 2 - 11 (37.9%) Grade 3 - 11 (37.9%) Grade 4 - 1 (3.4%) |
|
|
| Secondary | Adverse Events | Occurrence of adverse events after the beginning of radiotherapy | Posted | Count of Participants | Participants | From the first day of radiotherapy up to eight weeks |
|
|
|
| 0 |
| 34 |
| 0 |
| 34 |
| 33 |
| 34 |
| EG001 | Group Control | Maximum RTOG grade - Intention to Treat: Grade 1 - 6 (20.7%) Grade 2 - 11 (37.9%) Grade 3 - 11 (37.9%) Grade 4 - 1 (3.4%) | 0 | 29 | 1 | 29 | 28 | 29 |
|
| Stinging | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
|
| Body fluid losses before radiotherapy | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
|
| Anal fistula | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
|
| Body fluid losses during radiotherapy | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Fecal incontinence | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | CTCAE (5.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Herpes simplex reactivation | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Urinary tract pain | Renal and urinary disorders | CTCAE (5.0) | Systematic Assessment |
|
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| Relief |
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| Discomfot |
|
| Stinging |
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| Diarrhea |
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| Fecal incontinence |
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| Urinary incontinence |
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| Fistula |
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| Constipation |
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| Herpes simplex |
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| Adult Acute Respiratory Syndrome |
|
| Nausea |
|
| Urinary tract pain |
|