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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04851522
Other study ID # 21-078
Secondary ID
Status Withdrawn
Phase Early Phase 1
First received
Last updated
Start date June 9, 2021
Est. completion date April 1, 2023

Study information

Verified date January 2022
Source Dana-Farber Cancer Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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. .


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date April 1, 2023
Est. primary completion date April 1, 2022
Accepts healthy volunteers No
Gender All
Age group 12 Years to 25 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Di-Dak-Sol
Topical solution applied externally.
Other:
White Petrolatum
Topical ointment applied externally

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Dana-Farber Cancer Institute

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Number of Participants with Radiation dermatitis Incidence and severity of radiation dermatitis according to CTCAE v5.0 grade analyzed using descriptive statistics. 1 year
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