Dilute Bleach Compresses for Radiation Dermatitis
Primary Purpose
Radiation Dermatitis
Status
Withdrawn
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Di-Dak-Sol
White Petrolatum
Sponsored by
About this trial
This is an interventional supportive care trial for Radiation Dermatitis focused on measuring Radiation Dermatitis
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Di-Dak-Sol + White Petrolatum
Arm Description
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 .
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Number of Participants with Radiation dermatitis
Incidence and severity of radiation dermatitis according to CTCAE v5.0 grade analyzed using descriptive statistics.
Full Information
NCT ID
NCT04851522
First Posted
April 16, 2021
Last Updated
January 31, 2022
Sponsor
Dana-Farber Cancer Institute
1. Study Identification
Unique Protocol Identification Number
NCT04851522
Brief Title
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
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of patient accrual in the past year.
Study Start Date
June 9, 2021 (Anticipated)
Primary Completion Date
April 1, 2022 (Anticipated)
Study Completion Date
April 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiation Dermatitis
Keywords
Radiation Dermatitis
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Di-Dak-Sol + White Petrolatum
Arm Type
Experimental
Arm Description
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 .
Intervention Type
Drug
Intervention Name(s)
Di-Dak-Sol
Other Intervention Name(s)
Sodium Hypochlorite, Diluted NaOCl
Intervention Description
Topical solution applied externally.
Intervention Type
Other
Intervention Name(s)
White Petrolatum
Other Intervention Name(s)
Petroleum jelly, Soft paraffin, Multi-hydrocarbon
Intervention Description
Topical ointment applied externally
Primary Outcome Measure Information:
Title
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE Version 5.0
Description
The number and proportion of adverse events, graded as defined by CTCAE version 5.0 will be tabulated by type and grade.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Number of Participants with Radiation dermatitis
Description
Incidence and severity of radiation dermatitis according to CTCAE v5.0 grade analyzed using descriptive statistics.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Huang, MD
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
Data can be shared no earlier than 1 year following the date of publication
IPD Sharing 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
Learn more about this trial
Dilute Bleach Compresses for Radiation Dermatitis
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