Back to results

Utilizing Topical Sodium Hypochlorite to Ameliorate Radiation Dermatitis

Primary Purpose

Radiation Dermatitis

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Dilute Sodium Hypochlorite solution

About this trial

This is an interventional other trial for Radiation Dermatitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Northwestern University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment with Dilute Sodium Hypochlorite solution

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

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.

Improvement in patient reported outcome measures

Patient reported outcome survey results will be scored prior to and after compress treatment.

Secondary Outcome Measures

Full Information

NCT ID

NCT04630821

First Posted

November 11, 2020

Last Updated

August 14, 2022

Sponsor

Northwestern University

1. Study Identification

Unique Protocol Identification Number

NCT04630821

Brief Title

Utilizing Topical Sodium Hypochlorite to Ameliorate Radiation Dermatitis

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Terminated

Why Stopped

Low participant accrual

Study Start Date

February 8, 2021 (Actual)

Primary Completion Date

April 25, 2022 (Actual)

Study Completion Date

April 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Northwestern University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Radiation Dermatitis

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment with Dilute Sodium Hypochlorite solution

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Dilute Sodium Hypochlorite solution

Intervention Description

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.

Primary Outcome Measure Information:

Title

Compliance with compress application

Description

Time Frame

3 weeks

Title

Occurrence of adverse events from compress application

Description

The number of adverse events that occur in relation to the compress application will be tabulated during the course of the study.

Time Frame

3 weeks

Title

Improvement in patient reported outcome measures

Description

Patient reported outcome survey results will be scored prior to and after compress treatment.

Time Frame

3 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Amy Paller, MD

Organizational Affiliation

Department of Dermatology, Chair

Official's Role

Principal Investigator

Facility Information:

Facility Name

Northwestern University

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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

Learn more about this trial

Utilizing Topical Sodium Hypochlorite to Ameliorate Radiation Dermatitis

We'll reach out to this number within 24 hrs