Utilizing Topical Sodium Hypochlorite to Ameliorate Radiation Dermatitis

Not Applicable

Terminated

• Conditions: Radiation Dermatitis
• Interventions: Other: Dilute Sodium Hypochlorite solution

• Registration Number: NCT04630821
• Lead Sponsor: Northwestern University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-11-11
• Study First Submitted QC: 2020-11-11
• Study First Posted: 2020-11-16
• Study Start: 2021-02-08
• Primary Completion: 2022-04-25
• Study Completion: 2022-04-25
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-14
• Last Update Posted: 2022-08-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment with Dilute Sodium Hypochlorite solution	Dilute Sodium Hypochlorite solution	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.

Primary Outcome Measures

Name	Time	Method
Improvement in patient reported outcome measures	3 weeks	Patient reported outcome survey results will be scored prior to and after compress treatment.
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.

Trial Locations

Locations (1)

Northwestern University; 🇺🇸 Chicago, Illinois, United States