Dilute Bleach Compresses for Radiation Dermatitis

Study Overview
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Brief Summary
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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
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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. .

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

Conditions
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Radiation Dermatitis

Intervention / Treatment
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* Drug: Di-Dak-Sol
* Other: White Petrolatum


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Di-Dak-Sol + White Petrolatum<br>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<br>* Topical solution applied externally.<br>* Other names: Diluted NaOCl;Other: White Petrolatum<br>* Topical ointment applied externally<br>* Other names: Multi-hydrocarbon;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radiation Dermatitis