Study Stopped
Lack of patient accrual in the past year.
Dilute Bleach Compresses for Radiation Dermatitis
The Impact of Dilute Bleach Compresses on the Incidence and Severity of Radiation Dermatitis
1 other identifier
interventional
N/A
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jun 2021
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 16, 2021
CompletedFirst Posted
Study publicly available on registry
April 20, 2021
CompletedStudy Start
First participant enrolled
June 9, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2023
CompletedFebruary 15, 2022
January 1, 2022
10 months
April 16, 2021
January 31, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Number of Participants with Radiation dermatitis
1 year
Study Arms (1)
Di-Dak-Sol + White Petrolatum
EXPERIMENTALParticipants 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 .
Interventions
Topical solution applied externally.
Topical ointment applied externally
Eligibility Criteria
You may qualify if:
- Diagnosed with a rhabdomyosarcoma or other sarcoma requiring RT
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jennifer Huang, MD
Boston Children's Hospital
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 16, 2021
First Posted
April 20, 2021
Study Start
June 9, 2021
Primary Completion
April 1, 2022
Study Completion
April 1, 2023
Last Updated
February 15, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication
- Access Criteria
- Contact the Technology \& Innovation Development Office at www.childrensinnovations.org or email TIDO@childrens.harvard.edu Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.