Radiation Dermatitis
Conditions
Brief summary
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.
Interventions
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.
Sponsors
Montefiore Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 * Diagnosis of a solid tumor of the breast or head and neck with plans for fractionated radiation therapy (≥ 15 fractions) with curative intent
Exclusion criteria
* Prior RT to the region of interest * Existing dermatologic condition affecting the treatment area (eg: atopic dermatitis, psoriasis, and non-healing wounds) * Known allergy to chlorhexidine or mupirocin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Incidence of High Grade Radiation Dermatitis | Last treatment session (study week depends on patient's length of treatment), approximately 5 to 8 weeks | 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. |
| Median Change in Quality of Life Scoring Rated by the Skindex-16 Dermatological Survey | 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 | 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. |
Countries
United States
Participant flow
Recruitment details
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
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| Treatment Arm 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. | 39 |
| Control Patients in the control arm will be treated according to standard of care without any radiation dermatitis prophylaxis. | 38 |
| Total | 77 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Did not start radiotherapy | 1 | 2 |
Baseline characteristics
| Characteristic | Total | Control | Treatment Arm |
|---|---|---|---|
| Age, Continuous | 59.88 years STANDARD_DEVIATION 11.89 | 60.42 years STANDARD_DEVIATION 13.26 | 59.36 years STANDARD_DEVIATION 10.54 |
| Baseline Nasal Staph. aureus Colonization | 11 Participants | 6 Participants | 5 Participants |
| BMI | 29.45 kg/m^2 STANDARD_DEVIATION 5.73 | 30.10 kg/m^2 STANDARD_DEVIATION 5.2 | 28.55 kg/m^2 STANDARD_DEVIATION 6.07 |
| Cancer Type Breast | 75 Participants | 37 Participants | 38 Participants |
| Cancer Type Head and Neck | 2 Participants | 1 Participants | 1 Participants |
| Concurrent Chemotherapy | 5 Participants | 3 Participants | 2 Participants |
| Prior Chemotherapy | 41 Participants | 20 Participants | 21 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Black | 26 Participants | 10 Participants | 16 Participants |
| Race/Ethnicity, Customized Hispanic | 25 Participants | 13 Participants | 12 Participants |
| Race/Ethnicity, Customized Unknown | 21 Participants | 11 Participants | 10 Participants |
| Race/Ethnicity, Customized White | 4 Participants | 4 Participants | 0 Participants |
| Sex: Female, Male Female | 75 Participants | 38 Participants | 37 Participants |
| Sex: Female, Male Male | 2 Participants | 0 Participants | 2 Participants |
| Silver Sulfadiazine Use | 9 Participants | 5 Participants | 4 Participants |
| Total Number of Fractions Delivered | 20 fractions | 20 fractions | 20 fractions |
| Total Radiation Dose | 52.4 Gy | 52.4 Gy | 52.4 Gy |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 39 | 0 / 38 |
| other Total, other adverse events | 1 / 39 | 0 / 38 |
| serious Total, serious adverse events | 0 / 39 | 0 / 38 |
Outcome results
Primary
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
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Treatment Arm | Median Change in Quality of Life Scoring Rated by the Skindex-16 Dermatological Survey | Symptoms | 3 change in score on a scale |
| Treatment Arm | Median Change in Quality of Life Scoring Rated by the Skindex-16 Dermatological Survey | Emotions | 5 change in score on a scale |
| Treatment Arm | Median Change in Quality of Life Scoring Rated by the Skindex-16 Dermatological Survey | Functioning | 0 change in score on a scale |
| Control | Median Change in Quality of Life Scoring Rated by the Skindex-16 Dermatological Survey | Symptoms | 4 change in score on a scale |
| Control | Median Change in Quality of Life Scoring Rated by the Skindex-16 Dermatological Survey | Emotions | 0 change in score on a scale |
| Control | Median Change in Quality of Life Scoring Rated by the Skindex-16 Dermatological Survey | Functioning | 0 change in score on a scale |
p-value: 0.2Wilcoxon (Mann-Whitney)
p-value: 0.05Wilcoxon (Mann-Whitney)
p-value: 0.73Wilcoxon (Mann-Whitney)
Primary
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
Population: Intent to treat population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment Arm | Number of Participants With Incidence of High Grade Radiation Dermatitis | 0 Participants |
| Control | Number of Participants With Incidence of High Grade Radiation Dermatitis | 9 Participants |
p-value: 0.00495% CI: [-0.75, -0.15]Fisher Exact