Trial Outcomes & Findings for Bacterial Decolonization to Prevent Radiation Dermatitis (NCT NCT03883828)
NCT ID: NCT03883828
Last Updated: 2023-11-13
Results Overview
The number of high-grade radiation dermatitis events (grade 2-5) were assessed at the end of treatment. Instances of Grade 2-5 radiation dermatitis was assessed using photographs taken during the final radiation therapy visit. A blinded dermatologist viewed the images and assessed for toxicity grading using CTCAE Version 5.0 criteria.
COMPLETED
PHASE2/PHASE3
80 participants
Last treatment session (study week depends on patient's length of treatment), approximately 5 to 8 weeks
2023-11-13
Participant Flow
Enrollment took place at Montefiore Medical Center between June 2019 and August 2021. The first participant was enrolled into the study on June 3, 2019
80 patients were randomly assigned in a 1:1 manner to either the bacterial decolonization (treatment) arm or standard of care (control) arm. Three patients (1 assigned to the bacterial decolonization arm and 2 assigned to the control arm) were excluded from analysis because they did not start radiation therapy after enrollment. As such, the final population included 77 patients with breast cancer or head and neck cancer (39 assigned in the treatment arm and and 38 in the standard of care arm).
Participant milestones
| Measure |
Treatment Arm
Patients in the intervention arm receive a decolonization regimen, consisting of intranasal mupirocin ointment to be applied twice daily to the nares and chlorhexidine wash to be used once daily to the body.
|
Control
Patients in the control arm will be treated according to standard of care without any radiation dermatitis prophylaxis.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
COMPLETED
|
39
|
38
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Treatment Arm
Patients in the intervention arm receive a decolonization regimen, consisting of intranasal mupirocin ointment to be applied twice daily to the nares and chlorhexidine wash to be used once daily to the body.
|
Control
Patients in the control arm will be treated according to standard of care without any radiation dermatitis prophylaxis.
|
|---|---|---|
|
Overall Study
Did not start radiotherapy
|
1
|
2
|
Baseline Characteristics
Bacterial Decolonization to Prevent Radiation Dermatitis
Baseline characteristics by cohort
| Measure |
Treatment Arm
n=39 Participants
The purpose of this study is to determine whether bacterial decolonization of the nares and skin prior to treatment with radiotherapy (RT) for patients with cancers of the head and neck or breast, can prevent high-grade radiation dermatitis (RD) and improve quality of life. This study is being conducted because prior studies from this research group have found bacterial colonization in the nose prior to initiation of RT to be associated with an increased risk of high-grade RD. Patients in the treatment arm will receive pretreatment with mupirocin ointment to the nares and chlorhexidine wash to the body while patients in the control arm will receive standard of care treatment. Bacterial cultures will be taken from the nares and skin, and participants will also complete a quality of life questionnaire before and after RT.
Chlorhexidine gluconate solution: Patients in the intervention arm will receive a decolonization regimen, consisting of intranasal mupirocin ointment to be applied twice daily to the nares and chlorhexidine wash to be used once daily to the body.
Mupirocin Ointment: Patients in the intervention arm will receive a decolonization regimen, consisting of intranasal mupirocin ointment to be applied twice daily to the nares and chlorhexidine wash to be used once daily to the body.
|
Control
n=38 Participants
Patients in the control arm will be treated according to standard of care without any radiation dermatitis prophylaxis.
|
Total
n=77 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.36 years
STANDARD_DEVIATION 10.54 • n=5 Participants
|
60.42 years
STANDARD_DEVIATION 13.26 • n=7 Participants
|
59.88 years
STANDARD_DEVIATION 11.89 • n=5 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
16 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
BMI
|
28.55 kg/m^2
STANDARD_DEVIATION 6.07 • n=5 Participants
|
30.10 kg/m^2
STANDARD_DEVIATION 5.20 • n=7 Participants
|
29.45 kg/m^2
STANDARD_DEVIATION 5.73 • n=5 Participants
|
|
Cancer Type
Breast
|
38 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Cancer Type
Head and Neck
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Total Radiation Dose
|
52.4 Gy
n=5 Participants
|
52.4 Gy
n=7 Participants
|
52.4 Gy
n=5 Participants
|
|
Total Number of Fractions Delivered
|
20 fractions
n=5 Participants
|
20 fractions
n=7 Participants
|
20 fractions
n=5 Participants
|
|
Concurrent Chemotherapy
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Prior Chemotherapy
|
21 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Baseline Nasal Staph. aureus Colonization
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Silver Sulfadiazine Use
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Last treatment session (study week depends on patient's length of treatment), approximately 5 to 8 weeksPopulation: Intent to treat population
The number of high-grade radiation dermatitis events (grade 2-5) were assessed at the end of treatment. Instances of Grade 2-5 radiation dermatitis was assessed using photographs taken during the final radiation therapy visit. A blinded dermatologist viewed the images and assessed for toxicity grading using CTCAE Version 5.0 criteria.
Outcome measures
| Measure |
Treatment Arm
n=39 Participants
Patients in the intervention arm receive a decolonization regimen, consisting of intranasal mupirocin ointment to be applied twice daily to the nares and chlorhexidine wash to be used once daily to the body.
|
Control
n=38 Participants
Patients in the control arm will be treated according to standard of care without any radiation dermatitis prophylaxis.
|
|---|---|---|
|
Number of Participants With Incidence of High Grade Radiation Dermatitis
|
0 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: From the first week (week 1) to the last week of treatment (study week depends on patient's length of treatment), approximately 5 to 8 weeksPopulation: Intent to treat analysis. Data was not collected from one participant in the treatment arm and one participant in the control arm resulting in 38 and 37 participants analyzed in the treatment and control arms, respectively.
Change in quality of life from the beginning to the end of radiation therapy was used to assess if patients receiving decolonization experienced less impact on quality of life compared to standard of care radiation therapy treatment based on the Skindex-16 survey. The Skindex-16 is a validated 16-item self-administered survey instrument that measures the effects of skin disease on patients' quality of life. Scores were determined based on changes from baseline in the three scale subcategories: Symptoms (four items, range 0-24), Emotions (seven items, range 0-42), and Functioning (five items, range 0-30) where 0 = never bothered and 6 = always bothered. Net positive changes in respective subscale scoring were correlated with an improvement in that particular Quality of life assessment (i.e., Symptoms, Emotions, Functioning), while net negative changes in scoring corresponded to a decrease in that particular Quality of life assessment.
Outcome measures
| Measure |
Treatment Arm
n=38 Participants
Patients in the intervention arm receive a decolonization regimen, consisting of intranasal mupirocin ointment to be applied twice daily to the nares and chlorhexidine wash to be used once daily to the body.
|
Control
n=37 Participants
Patients in the control arm will be treated according to standard of care without any radiation dermatitis prophylaxis.
|
|---|---|---|
|
Median Change in Quality of Life Scoring Rated by the Skindex-16 Dermatological Survey
Symptoms
|
3 change in score on a scale
Interval -1.0 to 8.0
|
4 change in score on a scale
Interval 1.0 to 8.0
|
|
Median Change in Quality of Life Scoring Rated by the Skindex-16 Dermatological Survey
Emotions
|
5 change in score on a scale
Interval 0.0 to 10.0
|
0 change in score on a scale
Interval -1.0 to 6.0
|
|
Median Change in Quality of Life Scoring Rated by the Skindex-16 Dermatological Survey
Functioning
|
0 change in score on a scale
Interval 0.0 to 2.0
|
0 change in score on a scale
Interval 0.0 to 2.0
|
Adverse Events
Treatment Arm
Control
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment Arm
n=39 participants at risk
Patients in the intervention arm receive a decolonization regimen, consisting of intranasal mupirocin ointment to be applied twice daily to the nares and chlorhexidine wash to be used once daily to the body.
|
Control
n=38 participants at risk
Patients in the control arm will be treated according to standard of care without any radiation dermatitis prophylaxis.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Itch
|
2.6%
1/39 • Number of events 1 • The adverse event monitoring period spanned the duration of the intervention (5 days before radiotherapy start and until the last day of radiotherapy) for each patient. This varies per patient between 5 to 8 weeks.
|
0.00%
0/38 • The adverse event monitoring period spanned the duration of the intervention (5 days before radiotherapy start and until the last day of radiotherapy) for each patient. This varies per patient between 5 to 8 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place