Clinical trial NCT04851522: Dilute Bleach Compresses for Radiation Dermatitis
Official title: The Impact of Dilute Bleach Compresses on the Incidence and Severity of Radiation Dermatitis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: Radiation Dermatitis
Keywords: Radiation Dermatitis
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
First posted: 2021-04-20
Enrollment: 0
Sex: ALL
Minimum age (years): 12
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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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Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE Version 5.0
timeFrame: 1 year
Secondary outcomes:
measure: Number of Participants with Radiation dermatitis
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Boston Children's Hospital
name: Jennifer Huang, MD
role: PRINCIPAL_INVESTIGATOR
References: