Utilizing Topical Sodium Hypochlorite to Ameliorate Radiation Dermatitis

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

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.

Study Overview

• Status: Terminated
• Conditions: Radiation Dermatitis
• Intervention / Treatment: Other: Dilute Sodium Hypochlorite solution

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Treatment with 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Improvement in patient reported outcome measures	Patient reported outcome survey results will be scored prior to and after compress treatment.	3 weeks

Collaborators and Investigators

• Sponsor: Northwestern University
• Investigators: Principal Investigator: Amy Paller, MD, Department of Dermatology, Chair

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 8, 2021
• Primary Completion (ACTUAL): April 25, 2022
• Study Completion (ACTUAL): April 25, 2022

Study Registration Dates

• First Submitted: November 11, 2020
• First Submitted That Met QC Criteria: November 11, 2020
• First Posted (ACTUAL): November 16, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 17, 2022
• Last Update Submitted That Met QC Criteria: August 14, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Wounds and Injuries; Radiation Injuries; Dermatitis; Radiodermatitis; Anti-Infective Agents; Disinfectants; Sodium Hypochlorite; Eusol
• Other Study ID Numbers: AP09042019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: at the end of data collection
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No