Injury, Radiation, Radiodermatitis
Conditions
Keywords
barrier film, spray skin protection, liquid-film, barrier product
Brief 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. 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.
Interventions
OTHERmoisturizer Dnativ Revita derm
Patients will use conventional preventive treatment from the randomization day until the last day of radiotherapy.
OTHERSpray skin protector
Patients will use spray skin protector treatment from the randomization day until the last day of radiotherapy.
Sponsors
Rio de Janeiro State Research Supporting Foundation (FAPERJ)
Instituto Nacional de Cancer, Brazil
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
Blinding will be in skin evaluation and statistical analysis.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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). \-
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. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Categorized by RTOG Grading Scale | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | From the first day of radiotherapy up to eight weeks | Occurrence of adverse events after the beginning of radiotherapy |
Countries
Brazil
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group Experimental Intention to treat | 34 |
| Group Control Intention to treat | 29 |
| Total | 63 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Physician Decision | 2 | 6 |
| Overall Study | Withdrawal by Subject | 3 | 0 |
Baseline characteristics
| Characteristic | Group Experimental | Group Control | Total |
|---|---|---|---|
| Age, Customized 21-66 | 19 Participants | 17 Participants | 36 Participants |
| Age, Customized 67-90 | 15 Participants | 12 Participants | 27 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black | 3 Participants | 6 Participants | 9 Participants |
| Race/Ethnicity, Customized Brown | 22 Participants | 8 Participants | 30 Participants |
| Race/Ethnicity, Customized Indigenous | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 9 Participants | 14 Participants | 23 Participants |
| Region of Enrollment Brazil | 34 participants | 29 participants | 63 participants |
| Sex: Female, Male Female | 19 Participants | 20 Participants | 39 Participants |
| Sex: Female, Male Male | 15 Participants | 9 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 34 | 0 / 29 |
| other Total, other adverse events | 33 / 34 | 28 / 29 |
| serious Total, serious adverse events | 0 / 34 | 1 / 29 |
Outcome results
Primary
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.
Time frame: From the first day of radiotherapy up to eight weeks
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group Experimental | Number of Participants Categorized by RTOG Grading Scale | RTOG Grade 1 | 12 Participants |
| Group Experimental | Number of Participants Categorized by RTOG Grading Scale | RTOG Grade 2 | 11 Participants |
| Group Experimental | Number of Participants Categorized by RTOG Grading Scale | RTOG Grade 3 | 10 Participants |
| Group Experimental | Number of Participants Categorized by RTOG Grading Scale | RTOG Grade 4 | 1 Participants |
| Group Control | Number of Participants Categorized by RTOG Grading Scale | RTOG Grade 4 | 1 Participants |
| Group Control | Number of Participants Categorized by RTOG Grading Scale | RTOG Grade 1 | 6 Participants |
| Group Control | Number of Participants Categorized by RTOG Grading Scale | RTOG Grade 3 | 11 Participants |
| Group Control | Number of Participants Categorized by RTOG Grading Scale | RTOG Grade 2 | 11 Participants |
Secondary
Adverse Events
Occurrence of adverse events after the beginning of radiotherapy
Time frame: From the first day of radiotherapy up to eight weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group Experimental | Adverse Events | Discomfot | 5 Participants |
| Group Experimental | Adverse Events | Urinary incontinence | 16 Participants |
| Group Experimental | Adverse Events | Body fluid losses before radiotherapy | 29 Participants |
| Group Experimental | Adverse Events | Fistula | 1 Participants |
| Group Experimental | Adverse Events | Stinging | 5 Participants |
| Group Experimental | Adverse Events | Constipation | 1 Participants |
| Group Experimental | Adverse Events | Relief | 14 Participants |
| Group Experimental | Adverse Events | Herpes simplex | 1 Participants |
| Group Experimental | Adverse Events | Diarrhea | 7 Participants |
| Group Experimental | Adverse Events | Body fluid losses during radiotherapy | 33 Participants |
| Group Experimental | Adverse Events | Nausea | 2 Participants |
| Group Experimental | Adverse Events | Fecal incontinence | 12 Participants |
| Group Experimental | Adverse Events | Urinary tract pain | 1 Participants |
| Group Experimental | Adverse Events | Adult Acute Respiratory Syndrome | 0 Participants |
| Group Control | Adverse Events | Urinary tract pain | 2 Participants |
| Group Control | Adverse Events | Body fluid losses before radiotherapy | 23 Participants |
| Group Control | Adverse Events | Body fluid losses during radiotherapy | 28 Participants |
| Group Control | Adverse Events | Relief | 12 Participants |
| Group Control | Adverse Events | Discomfot | 2 Participants |
| Group Control | Adverse Events | Stinging | 5 Participants |
| Group Control | Adverse Events | Diarrhea | 12 Participants |
| Group Control | Adverse Events | Fecal incontinence | 10 Participants |
| Group Control | Adverse Events | Urinary incontinence | 11 Participants |
| Group Control | Adverse Events | Fistula | 1 Participants |
| Group Control | Adverse Events | Constipation | 5 Participants |
| Group Control | Adverse Events | Herpes simplex | 1 Participants |
| Group Control | Adverse Events | Adult Acute Respiratory Syndrome | 1 Participants |
| Group Control | Adverse Events | Nausea | 2 Participants |