Dilute Bleach Compresses for Radiation Dermatitis

Early Phase 1

Withdrawn

• Conditions: Radiation Dermatitis
• Interventions: Drug: Di-Dak-Sol; Other: White Petrolatum

• Registration Number: NCT04851522
• Lead Sponsor: Dana-Farber Cancer Institute

Brief Summary

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

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 Timeline

• Study First Submitted: 2021-04-16
• Study First Submitted QC: 2021-04-16
• Study First Posted: 2021-04-20
• Study Start: 2021-06-09
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-31
• Last Update Posted: 2022-02-15
• Primary Completion: 2022-04-01
• Study Completion: 2023-04-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Di-Dak-Sol + White Petrolatum	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 .
Di-Dak-Sol + White Petrolatum	Di-Dak-Sol	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 .

Primary Outcome Measures

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

Secondary Outcome Measures

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