Trial Outcomes & Findings for Study Using Spray Skin Protector Versus Conventional Treatment to Prevent Acute Radiodermatitis. (NCT NCT04067310)
NCT ID: NCT04067310
Last Updated: 2024-12-09
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
72 participants
Primary outcome timeframe
From the first day of radiotherapy up to eight weeks
Results posted on
2024-12-09
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
36
|
36
|
|
Overall Study
COMPLETED
|
31
|
29
|
|
Overall Study
NOT COMPLETED
|
5
|
7
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Physician Decision
|
2
|
6
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
Baseline Characteristics
Study Using Spray Skin Protector Versus Conventional Treatment to Prevent Acute Radiodermatitis.
Baseline characteristics by cohort
| Measure |
Group Experimental
n=34 Participants
Intention to treat
|
Group Control
n=29 Participants
Intention to treat
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
21-66
|
19 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Age, Customized
67-90
|
15 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
9 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Brown
|
22 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Indigenous
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
34 participants
n=5 Participants
|
29 participants
n=7 Participants
|
63 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From the first day of radiotherapy up to eight weeksPopulation: 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.
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.
Outcome measures
| Measure |
Group Experimental
n=34 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%)
|
Group Control
n=29 Participants
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%)
|
|---|---|---|
|
Number of Participants Categorized by RTOG Grading Scale
RTOG Grade 3
|
10 Participants
|
11 Participants
|
|
Number of Participants Categorized by RTOG Grading Scale
RTOG Grade 4
|
1 Participants
|
1 Participants
|
|
Number of Participants Categorized by RTOG Grading Scale
RTOG Grade 1
|
12 Participants
|
6 Participants
|
|
Number of Participants Categorized by RTOG Grading Scale
RTOG Grade 2
|
11 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: From the first day of radiotherapy up to eight weeksOccurrence of adverse events after the beginning of radiotherapy
Outcome measures
| Measure |
Group Experimental
n=34 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%)
|
Group Control
n=29 Participants
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%)
|
|---|---|---|
|
Adverse Events
Urinary incontinence
|
16 Participants
|
11 Participants
|
|
Adverse Events
Fistula
|
1 Participants
|
1 Participants
|
|
Adverse Events
Constipation
|
1 Participants
|
5 Participants
|
|
Adverse Events
Herpes simplex
|
1 Participants
|
1 Participants
|
|
Adverse Events
Adult Acute Respiratory Syndrome
|
0 Participants
|
1 Participants
|
|
Adverse Events
Nausea
|
2 Participants
|
2 Participants
|
|
Adverse Events
Urinary tract pain
|
1 Participants
|
2 Participants
|
|
Adverse Events
Body fluid losses before radiotherapy
|
29 Participants
|
23 Participants
|
|
Adverse Events
Body fluid losses during radiotherapy
|
33 Participants
|
28 Participants
|
|
Adverse Events
Relief
|
14 Participants
|
12 Participants
|
|
Adverse Events
Discomfot
|
5 Participants
|
2 Participants
|
|
Adverse Events
Stinging
|
5 Participants
|
5 Participants
|
|
Adverse Events
Diarrhea
|
7 Participants
|
12 Participants
|
|
Adverse Events
Fecal incontinence
|
12 Participants
|
10 Participants
|
Adverse Events
Group Experimental
Serious events: 0 serious events
Other events: 33 other events
Deaths: 0 deaths
Group Control
Serious events: 1 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group Experimental
n=34 participants at risk
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%)
|
Group Control
n=29 participants at risk
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%)
|
|---|---|---|
|
Infections and infestations
Lung infection
|
0.00%
0/34 • From the first day of radiotherapy up to eight weeks
|
3.4%
1/29 • Number of events 1 • From the first day of radiotherapy up to eight weeks
|
Other adverse events
| Measure |
Group Experimental
n=34 participants at risk
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%)
|
Group Control
n=29 participants at risk
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%)
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Discomfort
|
14.7%
5/34 • Number of events 5 • From the first day of radiotherapy up to eight weeks
|
13.8%
4/29 • Number of events 4 • From the first day of radiotherapy up to eight weeks
|
|
Skin and subcutaneous tissue disorders
Stinging
|
14.7%
5/34 • Number of events 5 • From the first day of radiotherapy up to eight weeks
|
17.2%
5/29 • Number of events 5 • From the first day of radiotherapy up to eight weeks
|
|
Skin and subcutaneous tissue disorders
Body fluid losses before radiotherapy
|
85.3%
29/34 • Number of events 29 • From the first day of radiotherapy up to eight weeks
|
79.3%
23/29 • Number of events 23 • From the first day of radiotherapy up to eight weeks
|
|
Skin and subcutaneous tissue disorders
Anal fistula
|
2.9%
1/34 • Number of events 1 • From the first day of radiotherapy up to eight weeks
|
3.4%
1/29 • Number of events 1 • From the first day of radiotherapy up to eight weeks
|
|
Skin and subcutaneous tissue disorders
Body fluid losses during radiotherapy
|
97.1%
33/34 • Number of events 33 • From the first day of radiotherapy up to eight weeks
|
96.6%
28/29 • Number of events 28 • From the first day of radiotherapy up to eight weeks
|
|
Gastrointestinal disorders
Diarrhea
|
20.6%
7/34 • Number of events 7 • From the first day of radiotherapy up to eight weeks
|
41.4%
12/29 • Number of events 12 • From the first day of radiotherapy up to eight weeks
|
|
Gastrointestinal disorders
Fecal incontinence
|
35.3%
12/34 • Number of events 12 • From the first day of radiotherapy up to eight weeks
|
34.5%
10/29 • Number of events 10 • From the first day of radiotherapy up to eight weeks
|
|
Renal and urinary disorders
Urinary incontinence
|
47.1%
16/34 • Number of events 16 • From the first day of radiotherapy up to eight weeks
|
37.9%
11/29 • Number of events 11 • From the first day of radiotherapy up to eight weeks
|
|
Gastrointestinal disorders
Constipation
|
2.9%
1/34 • Number of events 1 • From the first day of radiotherapy up to eight weeks
|
17.2%
5/29 • Number of events 5 • From the first day of radiotherapy up to eight weeks
|
|
Infections and infestations
Herpes simplex reactivation
|
2.9%
1/34 • Number of events 1 • From the first day of radiotherapy up to eight weeks
|
3.4%
1/29 • Number of events 1 • From the first day of radiotherapy up to eight weeks
|
|
Gastrointestinal disorders
Nausea
|
5.9%
2/34 • Number of events 2 • From the first day of radiotherapy up to eight weeks
|
6.9%
2/29 • Number of events 2 • From the first day of radiotherapy up to eight weeks
|
|
Renal and urinary disorders
Urinary tract pain
|
2.9%
1/34 • Number of events 1 • From the first day of radiotherapy up to eight weeks
|
6.9%
2/29 • Number of events 2 • From the first day of radiotherapy up to eight weeks
|
Additional Information
Director of Clinical Trials
Instituto Nacional do Câncer
Phone: +552132076549
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place