Dilute Bleach Compresses for Radiation Dermatitis

Radiation Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04851522
• Other study ID #: 21-078
• Status: Withdrawn
• Phase: Early Phase 1
• Start date: June 9, 2021
• Est. completion date: April 1, 2023

Study information

• Verified date: January 2022
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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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Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 1, 2023
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Dermatitis
• Radiation Dermatitis
• Radiodermatitis

Intervention

Drug:
• Di-Dak-Sol
Topical solution applied externally.

Other:
• White Petrolatum
Topical ointment applied externally

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Participants with Radiation dermatitis	Incidence and severity of radiation dermatitis according to CTCAE v5.0 grade analyzed using descriptive statistics.	1 year