An interventional study of Dilute Sodium Hypochlorite solution in Radiation Dermatitis, sponsored by Northwestern University. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-17.
Sponsored by Northwestern University · Not applicable, Interventional, and Other
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.
139 studies on the registry are indexed under Radiodermatitis; 26 are open to participants now.
This study's enrollment of 6 is below the median of 55 across 114 interventional studies indexed under Radiodermatitis.
Browse Radiodermatitis studies →Northwestern University is the lead sponsor of 1,420 studies on the registry; 199 are open to participants now.
Of its 103 completed or terminated interventional studies of FDA-regulated products, 75 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
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.
Other: Dilute Sodium Hypochlorite solution
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.
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.
Time frame: 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.
Time frame: 3 weeks
Improvement in patient reported outcome measures
Patient reported outcome survey results will be scored prior to and after compress treatment.
Time frame: 3 weeks
Plan to share: Yes — 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.
Supporting information: Clinical study report
Time frame: at the end of data collection
No publications or documents are linked to this record.
Ran from Feb 2021 to primary completion in Apr 2022, 14 months.
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This study is terminated, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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