Dilute Bleach Compresses for Radiation Dermatitis

The Impact of Dilute Bleach Compresses on the Incidence and Severity of Radiation Dermatitis

This study is looking at the safety of applying dilute bleach compresses to patients receiving radiation therapy and the impact of these dilute bleach compresses on the frequency and severity of skin changes that occur during radiation therapy.

The names of the study interventions involved in this study are:

• Di-Dak-Sol: dilute bleach compresses
• White petrolatum ointment

Study Overview

• Status: Withdrawn
• Conditions: Radiation Dermatitis
• Intervention / Treatment: Drug: Di-Dak-Sol; Other: White Petrolatum

Detailed Description

This is a planned open-label prospective clinical trial to determine the safety of applying dilute bleach compresses to pediatric patients being treated for rhabdomyosarcoma and other soft tissue and bone sarcomas with radiation therapy (RT).

This study is interested in finding out whether dilute bleach compresses are safe to apply and evaluating their impact on the frequency and severity of skin changes that occur in children who are receiving radiation therapy for cancer treatment.

This information may help treat other patients receiving radiation therapy for cancer treatment in the future.

The research study procedures include screening for eligibility and study treatment including weekly evaluations and follow up visits

Participants will receive study treatment throughout their radiation therapy and for one week after. They will be followed for one month after the completion of radiation.

It is expected that about 12 people will take part in this research study.

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• Study Type: Interventional
• Phase: Early Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosed with a rhabdomyosarcoma or other sarcoma requiring RT
• 12 to 25 years of age
• Scheduled for a RT planning session (CT simulation)
• Have a scheduled RT start date within 1 to 2 weeks from the CT simulation
• Will be receiving doses of radiotherapy greater than at least 36 Gy
• Subjects may participate in other studies, including therapeutic trials.
• Ability to comply with at-home dilute Di-Dak-Sol compresses for final week of dilute Di-Dak-Sol compresses following radiation treatment.
• Ability to understand and/or the willingness of their parent or legally authorized representative to sign a written informed consent document.

Exclusion Criteria:

• Patients who are pregnant, which may result in discontinuation of RT
• Presence of inflammatory skin lesions in the radiation field that could interfere with assessment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Di-Dak-Sol + White Petrolatum; Participants will receive Di-Dak-Sol (dilute bleach compresses) prior to receiving radiation. This will continue throughout their radiation therapy and for one week after. Participants will also be asked to apply white petrolatum ointment 2x daily throughout treatment: once after radiation and once in the evening. Participants will be provided with a log and asked to document information (dates/times of application) about the study treatment .

Drug: Di-Dak-Sol; Topical solution applied externally.; Other Names: Sodium Hypochlorite; Diluted NaOCl; Other: White Petrolatum; Topical ointment applied externally; Other Names: Petroleum jelly; Soft paraffin; Multi-hydrocarbon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE Version 5.0	The number and proportion of adverse events, graded as defined by CTCAE version 5.0 will be tabulated by type and grade.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Radiation dermatitis	Incidence and severity of radiation dermatitis according to CTCAE v5.0 grade analyzed using descriptive statistics.	1 year

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute

Study record dates

Study Major Dates

• Study Start (Anticipated): June 9, 2021
• Primary Completion (Anticipated): April 1, 2022
• Study Completion (Anticipated): April 1, 2023

Study Registration Dates

• First Submitted: April 16, 2021
• First Submitted That Met QC Criteria: April 16, 2021
• First Posted (Actual): April 20, 2021

Study Record Updates

• Last Update Posted (Actual): February 15, 2022
• Last Update Submitted That Met QC Criteria: January 31, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Radiation Dermatitis
• Additional Relevant MeSH Terms: Skin Diseases; Wounds and Injuries; Radiation Injuries; Dermatitis; Radiodermatitis; Anti-Infective Agents; Dermatologic Agents; Emollients; Disinfectants; Petrolatum; Sodium Hypochlorite; Eusol
• Other Study ID Numbers: 21-078

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the Technology & Innovation Development Office at www.childrensinnovations.org or email TIDO@childrens.harvard.edu Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No