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Low participant accrual
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The objective of the pilot study is to determine compliance, acceptability, and feasibility of using topical sodium hypochlorite to ameliorate or reduce radiation dermatitis, and to collect preliminary data and estimates for planning a larger efficacy study.
This 3-week single-arm pilot study will collect information on subject treatment compliance and feedback from subjects (and nurses/subject's treating oncologist) on the acceptability of the use of the treatment. We will also collect data on Common Terminology Criteria for Adverse Events and patient reported outcomes measured using the pain and pruritus PROMIS short-form tools and patient reported outcomes, measured using the Dermatology Life Quality Index (DLQI) tool.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment with Dilute Sodium Hypochlorite solution | Experimental | Subjects will be treated with the dilute bleach compresses daily (Monday through Friday) for the first 3 weeks of therapy. The bleach solution will be prepared and compresses applied for a 20 minute duration prior to radiation therapy. The compress can be applied within an hour of radiation therapy. Subjects will apply Aquaphor® ointment twice a day, once immediately after the radiation treatment and once in the evening. On days the experimental subjects do not receive radiation therapy, they will continue to moisturize their skin twice a day (AM and PM) with Aquaphor® ointment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dilute Sodium Hypochlorite solution | Other | Subjects will be treated with the dilute bleach compresses daily for the first 3 weeks of therapy. While these subjects are undergoing radiation therapy, they will be assessed weekly before the day's compress treatment by a physician investigator on the study team. Subjects will be evaluated and photographs will also be taken at study visits 1-3. The subjects will also complete a subject questionnaire addressing patient-reported outcomes at baseline and each weekly check-in during these two weeks. They will be also interviewed about ease of use and treatment tolerability. Subjects will complete interview questions at the end of the study to determine if they would continue the treatment and any obstacles or barriers. |
| Measure | Description | Time Frame |
|---|---|---|
| Compliance with compress application | Compliance will be measured as the proportion of subjects who complete 80% or more of the compresses. We will consider the study 'successful' if ≥ 80% of patients complete 80% or more of the compresses. | 3 weeks |
| Occurrence of adverse events from compress application | The number of adverse events that occur in relation to the compress application will be tabulated during the course of the study. | 3 weeks |
| Improvement in patient reported outcome measures | Patient reported outcome survey results will be scored prior to and after compress treatment. | 3 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amy Paller, MD | Department of Dermatology, Chair | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States |
De-identified study results will be shared with our collaborative investigator at Boston Children's Hospital and Dana Farber/Harvard, Dr. Jennifer Huang, who is conducting a parallel adult study. This study will also inform our planned parallel studies with Dr. Huang in pediatric cancer patients undergoing radiation. Both sites will have access to each other's de-identified dataset once the appropriate Data Use Agreements are in place.
at the end of data collection
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| ID | Term |
|---|---|
| D011855 | Radiodermatitis |
| ID | Term |
|---|---|
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D011832 | Radiation Injuries |
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| D014947 |
| Wounds and Injuries |