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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Withdrawn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
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Radiation Dermatitis focused on measuring Radiation Dermatitis

Eligibility Criteria

12 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    April 16, 2021
    Last Updated
    January 31, 2022
    Sponsor
    Dana-Farber Cancer Institute
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    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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