Radiation DermatitisNCT04630821
Utilizing Topical Sodium Hypochlorite to Ameliorate Radiation Dermatitis
A study testing Dilute Sodium Hypochlorite solution in people with Radiation Dermatitis, run by Northwestern University at 1 site in United States.
Trial summary
The objective of the pilot study is to determine compliance, acceptability, and feasibility of using topical sodium hypochlorite to ameliorate or reduce radiation dermatitis, and to collect preliminary data and estimates for planning a larger efficacy study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiation Dermatitis
- What is being tested?
- Dilute Sodium Hypochlorite solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2021to 25 Apr 2022
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Been diagnosed with head and neck cancer requiring radiation therapy or skin cancer requiring radiation treatment to the neck
- Are scheduled for a radiation therapy planning session (CT simulation)
- Have a scheduled radiation therapy start date within 1 to 2 weeks from the CT simulation
- Are able to comply with the study protocol
Who cannot join
- Patients who are pregnant, which may lead to discontinuation of radiation therapy
- Patients currently on immunotherapy
- Active or past history of inflammatory lesions in the radiation field that could interfere with assessment
- Patients who are undergoing re-irradiation to the head and neck
- Patients must not have any other condition or situation beyond those listed above which, in the investigator's opinion, puts the patient at significant risk, could confound the study results, or may interfere significantly with the patient's participation in the study.
- Patients who are unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function are not eligible.
- Participation in other clinical trials that would alter the radiation dose typically utilized for definitive chemo and radiation therapy treatment of head and neck cancer.
- Use of other topical treatments on the skin in the treatment field. No other products are allowed except Aquaphor® ointment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study of Utilizing Topical Sodium Hypochlorite to Ameliorate or Reduce Radiation Dermatitis
The objective of the pilot study is to determine compliance, acceptability, and feasibility of using topical sodium hypochlorite to ameliorate or reduce radiation dermatitis, and to collect preliminary data and estimates for planning a larger efficacy study.
This 3-week single-arm pilot study will collect information on subject treatment compliance and feedback from subjects (and nurses/subject's treating oncologist) on the acceptability of the use of the treatment. We will also collect data on Common Terminology Criteria for Adverse Events and patient reported outcomes measured using the pain and pruritus PROMIS short-form tools and patient reported outcomes, measured using the Dermatology Life Quality Index (DLQI) tool.
- Conditions
- Radiation Dermatitis
- Being tested
- Dilute Sodium Hypochlorite solution
- Medical subject headings
- Radiodermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dilute Sodium Hypochlorite solutionOther
Subjects will be treated with the dilute bleach compresses daily for the first 3 weeks of therapy.
While these subjects are undergoing radiation therapy, they will be assessed weekly before the day's compress treatment by a physician investigator on the study team. Subjects will be evaluated and photographs will also be taken at study visits 1-3. The subjects will also complete a subject questionnaire addressing patient-reported outcomes at baseline and each weekly check-in during these two weeks. They will be also interviewed about ease of use and treatment tolerability. Subjects will complete interview questions at the end of the study to determine if they would continue the treatment and any obstacles or barriers.
| Study group | Role | What they receive |
|---|---|---|
| Treatment with Dilute Sodium Hypochlorite solution | Experimental | Subjects will be treated with the dilute bleach compresses daily (Monday through Friday) for the first 3 weeks of therapy. The bleach solution will be prepared and compresses applied for a 20 minute duration prior to radiation therapy. The compress can be applied within an hour of radiation therapy. Subjects will apply Aquaphor® ointment twice a day, once immediately after the radiation treatment and once in the evening. On days the experimental subjects do not receive radiation therapy, they will continue to moisturize their skin twice a day (AM and PM) with Aquaphor® ointment. Receives: Other: Dilute Sodium Hypochlorite solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance with compress application
Compliance will be measured as the proportion of subjects who complete 80% or more of the compresses. We will consider the study 'successful' if ≥ 80% of patients complete 80% or more of the compresses.
Measured: 3 weeks
Occurrence of adverse events from compress application
The number of adverse events that occur in relation to the compress application will be tabulated during the course of the study.
Measured: 3 weeks
Improvement in patient reported outcome measures
Patient reported outcome survey results will be scored prior to and after compress treatment.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start8 Feb 2021
- Primary completion25 Apr 2022
- Study completion25 Apr 2022
Why it stopped: Low participant accrual
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 Northwestern UniversityThe 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
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amy Paller, Northwestern University
- Investigators
- Amy Paller, MD, Principal investigator, Department of Dermatology, Chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04630821
- Sponsor's protocol ID
- AP09042019
- Status last verified
- Aug 2022
- First submitted
- 11 Nov 2020
- Last updated
- 17 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified study results will be shared with our collaborative investigator at Boston Children's Hospital and Dana Farber/Harvard, Dr. Jennifer Huang, who is conducting a parallel adult study. This study will also inform our planned parallel studies with Dr. Huang in pediatric cancer patients undergoing radiation. Both sites will have access to each other's de-identified dataset once the appropriate Data Use Agreements are in place.
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Utilizing Topical Sodium Hypochlorite to Ameliorate or Reduce Radiation Dermatitis
- ClinicalTrials.gov ID
- NCT04630821
- Acronym / sponsor ID
- AP09042019
- Conditions
- Radiation Dermatitis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low participant accrual
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 8 Feb 2021 (actual)
- Primary completion
- 25 Apr 2022 (actual)
- Study completion
- 25 Apr 2022 (actual)
- First posted
- 16 Nov 2020 (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.
The objective of the pilot study is to determine compliance, acceptability, and feasibility of using topical sodium hypochlorite to ameliorate or reduce radiation dermatitis, and to collect preliminary data and estimates for planning a larger efficacy study.
This 3-week single-arm pilot study will collect information on subject treatment compliance and feedback from subjects (and nurses/subject's treating oncologist) on the acceptability of the use of the treatment. We will also collect data on Common Terminology Criteria for Adverse Events and patient reported outcomes measured using the pain and pruritus PROMIS short-form tools and patient reported outcomes, measured using the Dermatology Life Quality Index (DLQI) tool.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment with Dilute Sodium Hypochlorite solution | Experimental | Other: Dilute Sodium Hypochlorite solutionSubjects will be treated with the dilute bleach compresses daily (Monday through Friday) for the first 3 weeks of therapy. The bleach solution will be prepared and compresses applied for a 20 minute duration prior to radiation therapy. The compress can be applied within an hour of radiation therapy. Subjects will apply Aquaphor® ointment twice a day, once immediately after the radiation treatment and once in the evening. On days the experimental subjects do not receive radiation therapy, they will continue to moisturize their skin twice a day (AM and PM) with Aquaphor® ointment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years of age or older
- Been diagnosed with head and neck cancer requiring radiation therapy or skin cancer requiring radiation treatment to the neck
- Are scheduled for a radiation therapy planning session (CT simulation)
- Have a scheduled radiation therapy start date within 1 to 2 weeks from the CT simulation
- Are able to comply with the study protocol
Key exclusion criteria (8 listed)
- Patients who are pregnant, which may lead to discontinuation of radiation therapy
- Patients currently on immunotherapy
- Active or past history of inflammatory lesions in the radiation field that could interfere with assessment
- Patients who are undergoing re-irradiation to the head and neck
- Patients must not have any other condition or situation beyond those listed above which, in the investigator's opinion, puts the patient at significant risk, could confound the study results, or may interfere significantly with the patient's participation in the study.
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 |
|---|---|---|
| Dilute Sodium Hypochlorite solutionSubjects will be treated with the dilute bleach compresses daily for the first 3 weeks of therapy. While these subjects are undergoing radiation therapy, they will be assessed weekly before the day's compress treatment by a physician investigator on the study team. Subjects will be evaluated and photographs will also be taken at study visits 1-3. The subjects will also complete a subject questionnaire addressing patient-reported outcomes at baseline and each weekly check-in during these two weeks. They will be also interviewed about ease of use and treatment tolerability. Subjects will complete interview questions at the end of the study to determine if they would continue the treatment and any obstacles or barriers. | Other | Treatment with Dilute Sodium Hypochlorite solution |
Primary outcome
Compliance with compress application
Time frame: 3 weeks
Compliance will be measured as the proportion of subjects who complete 80% or more of the compresses. We will consider the study 'successful' if ≥ 80% of patients complete 80% or more of the compresses.
Occurrence of adverse events from compress application
Time frame: 3 weeks
The number of adverse events that occur in relation to the compress application will be tabulated during the course of the study.
Improvement in patient reported outcome measures
Time frame: 3 weeks
Patient reported outcome survey results will be scored prior to and after compress treatment.
Results and safety
The study was stopped early (reason given: Low participant accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2022.
- Individual participant dataSharing planned: Yes. De-identified study results will be shared with our collaborative investigator at Boston Children's Hospital and Dana Farber/Harvard, Dr. Jennifer Huang, who is conducting a parallel adult study. This study will also inform our planned parallel studies with Dr. Huang in pediatric cancer patients undergoing radiation. Both sites will have access to each other's de-identified dataset once the appropriate Data Use Agreements are in place.
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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.
Amy Paller, MD principal investigator
Department of Dermatology, Chair
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dilute Sodium Hypochlorite solution in people with Radiation Dermatitis, run by Northwestern University at 1 site in United States.
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 5 inclusion and 8 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: stopped early, as of the sponsor's last update on 17 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study was stopped early (reason given: Low participant accrual). Results are not available in the source record.
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?
Compliance with compress application (time frame: 3 weeks). The study lists 3 primary outcomes in all. 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 17 Aug 2022.