NCT04851522

Dilute Bleach Compresses for Radiation Dermatitis

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

• Status: Withdrawn
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 12 Years – 25 Years
• Healthy volunteers: Not accepted

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. .

Conditions

• Radiation Dermatitis

Interventions

Type	Name	Description
DRUG	Di-Dak-Sol	Topical solution applied externally.
OTHER	White Petrolatum	Topical ointment applied externally

Timeline

• Start date: 2021-06-09
• Primary completion: 2022-04-01
• Completion: 2023-04-01
• First posted: 2021-04-20
• Last updated: 2022-02-15

Regulatory

• FDA-regulated drug study