Radiation Dermatitis
Conditions
Brief summary
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.
Interventions
OTHERDilute 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.
Sponsors
Northwestern University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age or older * Been diagnosed with head and neck cancer requiring radiation therapy or skin cancer requiring radiation treatment to the neck * Are scheduled for a radiation therapy planning session (CT simulation) * Have a scheduled radiation therapy start date within 1 to 2 weeks from the CT simulation * Are able to comply with the study protocol
Exclusion criteria
* Patients who are pregnant, which may lead to discontinuation of radiation therapy * Patients currently on immunotherapy * Active or past history of inflammatory lesions in the radiation field that could interfere with assessment * Patients who are undergoing re-irradiation to the head and neck * Patients must not have any other condition or situation beyond those listed above which, in the investigator's opinion, puts the patient at significant risk, could confound the study results, or may interfere significantly with the patient's participation in the study. * Patients who are unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function are not eligible. * Participation in other clinical trials that would alter the radiation dose typically utilized for definitive chemo and radiation therapy treatment of head and neck cancer. * Use of other topical treatments on the skin in the treatment field. No other products are allowed except Aquaphor® ointment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compliance with compress application | 3 weeks | 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. |
| Occurrence of adverse events from compress application | 3 weeks | The number of adverse events that occur in relation to the compress application will be tabulated during the course of the study. |
| Improvement in patient reported outcome measures | 3 weeks | Patient reported outcome survey results will be scored prior to and after compress treatment. |
Countries
United States
Outcome results
None listed