NCT04630821

Utilizing Topical Sodium Hypochlorite to Ameliorate Radiation Dermatitis

Pilot Study of Utilizing Topical Sodium Hypochlorite to Ameliorate or Reduce Radiation Dermatitis

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Radiation Dermatitis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-02-08
• Primary completion: 2022-04-25
• Completion: 2022-04-25
• First posted: 2020-11-16
• Last updated: 2022-08-17

Locations

1 site across 1 country: United States