Radiation DermatitisEarly Phase 1NCT04851522
Dilute Bleach Compresses for Radiation Dermatitis
A Early Phase 1 study testing Di-Dak-Sol and White Petrolatum in people with Radiation Dermatitis, run by Dana-Farber Cancer Institute.
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. Read more about this study
- Who is it for?
- Ages 12 to 25 years
- Conditions the study is for
- Radiation Dermatitis
- What is being tested?
- Di-Dak-Sol and White Petrolatum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 9 Jun 2021to 1 Apr 2023
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
About this study
Official title: The Impact of Dilute Bleach Compresses on the Incidence and Severity of Radiation Dermatitis
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
Read the 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.
.
- Conditions
- Radiation Dermatitis
- Being tested
- Di-Dak-Sol, White Petrolatum
- Keywords
- Radiation Dermatitis
- Medical subject headings
- Radiodermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Di-Dak-SolDrug
Also called Sodium Hypochlorite, Diluted NaOCl
Topical solution applied externally.
White PetrolatumOther
Also called Petroleum jelly, Soft paraffin, Multi-hydrocarbon
Topical ointment applied externally
| Study group | Role | What they receive |
|---|---|---|
| Di-Dak-Sol + White Petrolatum | Experimental | 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 . Receives: Drug: Di-Dak-Sol; Other: White Petrolatum |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (1)
Number of Participants with Radiation dermatitis
Incidence and severity of radiation dermatitis according to CTCAE v5.0 grade analyzed using descriptive statistics.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2021
- Study start9 Jun 2021 (estimated)
- Primary completion1 Apr 2022 (estimated)
- Study completion1 Apr 2023 (estimated)
Why it stopped: Lack of patient accrual in the past year.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation DermatitisStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Huang, MD, Dana-Farber Cancer Institute
- Investigators
- Jennifer Huang, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04851522
- Sponsor's protocol ID
- 21-078
- Status last verified
- Jan 2022
- First submitted
- 16 Apr 2021
- Last updated
- 15 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Dilute Bleach Compresses on the Incidence and Severity of Radiation Dermatitis
- ClinicalTrials.gov ID
- NCT04851522
- Acronym / sponsor ID
- 21-078
- Conditions
- Radiation Dermatitis
- Keywords
- Radiation Dermatitis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of patient accrual in the past year.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- 9 Jun 2021 (estimated)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 1 Apr 2023 (estimated)
- First posted
- 20 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Di-Dak-Sol + White Petrolatum | Experimental | Drug: Di-Dak-Sol, Other: White PetrolatumParticipants 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 . |
Who may qualify
- Ages
- 12 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Di-Dak-SolAlso: Sodium Hypochlorite, Diluted NaOClTopical solution applied externally. | Drug | Di-Dak-Sol + White Petrolatum |
| White PetrolatumAlso: Petroleum jelly, Soft paraffin, Multi-hydrocarbonTopical ointment applied externally | Other | Di-Dak-Sol + White Petrolatum |
Primary outcome
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE Version 5.0
Time frame: 1 year
The number and proportion of adverse events, graded as defined by CTCAE version 5.0 will be tabulated by type and grade.
1 secondary outcome
Number of Participants with Radiation dermatitis
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2022.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Huang, MD principal investigator
Boston Children's Hospital
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Di-Dak-Sol and White Petrolatum in people with Radiation Dermatitis, run by Dana-Farber Cancer Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE Version 5.0 (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2022.