Utilizing Topical Sodium Hypochlorite to Ameliorate Radiation Dermatitis

Radiation Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04630821
• Other study ID #: AP09042019
• Status: Terminated
• Phase: N/A
• Start date: February 8, 2021
• Est. completion date: April 25, 2022

Study information

• Verified date: August 2022
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: April 25, 2022
• Est. primary completion date: April 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dermatitis
• Radiation Dermatitis
• Radiodermatitis

Intervention

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.

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Improvement in patient reported outcome measures	Patient reported outcome survey results will be scored prior to and after compress treatment.	3 weeks