A Phase 2/3 interventional study of Chlorhexidine gluconate solution and Mupirocin Ointment in Radiation Dermatitis, sponsored by Montefiore Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-13.
Sponsored by Montefiore Medical Center · Phase 2/3, Interventional, and Prevention
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.
139 studies on the registry are indexed under Radiodermatitis; 26 are open to participants now.
This study's enrollment of 80 is above the median of 55 across 114 interventional studies indexed under Radiodermatitis.
Browse Radiodermatitis studies →Montefiore Medical Center is the lead sponsor of 414 studies on the registry; 69 are open to participants now.
Of its 86 completed or terminated interventional studies of FDA-regulated products, 76 (88%) have results posted.
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Exclusion Criteria:
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.
Drug: Chlorhexidine gluconate solution · Drug: Mupirocin Ointment
Patients in the control arm will be treated according to standard of care without any radiation dermatitis prophylaxis.
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.
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.
Number of Participants With Incidence of High Grade Radiation Dermatitis
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.
Time frame: Last treatment session (study week depends on patient's length of treatment), approximately 5 to 8 weeks
Median Change in Quality of Life Scoring Rated by the Skindex-16 Dermatological Survey
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.
Time frame: 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 weeks
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
| Milestone | Treatment Arm | Control |
|---|---|---|
| Started | 40 | 40 |
| Completed | 39 | 38 |
| Not completed | 1 | 2 |
| Withdrew: Did not start radiotherapy | 1 | 2 |
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.
| Participants | Treatment Arm | Control |
|---|---|---|
| Number of Participants With Incidence of High Grade Radiation Dermatitis | 0 | 9 |
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.
| change in score on a scale | Treatment Arm | Control |
|---|---|---|
| Symptoms | 3 (-1 to 8) | 4 (1 to 8) |
| Emotions | 5 (0 to 10) | 0 (-1 to 6) |
| Functioning | 0 (0 to 2) | 0 (0 to 2) |
Collected over 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.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment Arm | 0/39 (0%) | 0/39 (0%) | 1/39 (2.6%) |
| Control | 0/38 (0%) | 0/38 (0%) | 0/38 (0%) |
| Event | Treatment Arm | Control |
|---|---|---|
| ItchSkin and subcutaneous tissue disorders | 1/39 | 0/38 |
Baseline information and data was only collected for 77 participants (39 in the treatment arm and 38 in the control arm)
| Age, Continuous(years) | Treatment Arm | Control | Total |
|---|---|---|---|
| Mean | 59.36 ± 10.54 | 60.42 ± 13.26 | 59.88 ± 11.89 |
| Sex: Female, Male(Participants) | Treatment Arm | Control | Total |
|---|---|---|---|
| Female | 37 | 38 | 75 |
| Male | 2 | 0 | 2 |
| Race/Ethnicity, Customized(Participants) | Treatment Arm | Control | Total |
|---|---|---|---|
| Black | 16 | 10 | 26 |
| Hispanic | 12 | 13 | 25 |
| White | 0 | 4 | 4 |
| Asian | 1 | 0 | 1 |
| Unknown | 10 | 11 | 21 |
| BMI(kg/m^2) | Treatment Arm | Control | Total |
|---|---|---|---|
| Mean | 28.55 ± 6.07 | 30.10 ± 5.20 | 29.45 ± 5.73 |
| Cancer Type(Participants) | Treatment Arm | Control | Total |
|---|---|---|---|
| Breast | 38 | 37 | 75 |
| Head and Neck | 1 | 1 | 2 |
| Total Radiation Dose(Gy) | Treatment Arm | Control | Total |
|---|---|---|---|
| Median | 52.4 (42.4 to 52.4) | 52.4 (42.4 to 52.4) | 52.4 (42.4 to 52.4) |
| Total Number of Fractions Delivered(fractions) | Treatment Arm | Control | Total |
|---|---|---|---|
| Median | 20 (16 to 20) | 20 (16 to 20) | 20 (16 to 20) |
| Concurrent Chemotherapy(Participants) | Treatment Arm | Control | Total |
|---|---|---|---|
| Count of participants | 2 | 3 | 5 |
3 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
Ran from Jun 2019 to primary completion in Dec 2021, 29 months.
Results were first posted in Nov 2023, 1 year 11 months after primary completion.
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Studies of the drugs tested here: Chlorhexidine gluconate · Mupirocin