Radiation DermatitisNCT04715386
Feasibility in the Prophylaxis of Radiation Dermatitis Severity
An observational study of Radiation Dermatitis, run by Mayo Clinic at 1 site in United States.
Trial summary
To compare radiation dermatitis severity in irradiated skin protected by an agent verses uncovered skin based on photographs and track patient reported outcomes with use of the agent. 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?
- StrataXRT
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jun 2020to 30 Jan 2024
- Phase
- Observational
- 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
Study population: Adults with head and neck cancer
Who may be able to join
- Age ≥ 18years
- Undergoing external beam radiotherapy for head/neck cancer at Mayo Clinic Rochester campus.
- Note: patients undergoing concurrent chemotherapy are eligible.
- Able to provide informed written consent
- Willing to consent for photography of radiation field
- Receiving a dose ≥ 45 Gy and 20 fractions to both the area being treated and the area being used for comparison
Who cannot join
- Patients with active rash, pre-existing dermatitis, lupus, tattoos, scleroderma or other conditions within the treatment area that may make skin assessment for the study difficult per treating physician discretion.
- Patients with known allergic and other systemic skin diseases even if not directly affecting irradiated fields.
- Any medical condition that in the opinion of the investigator should exclude him/her from participating in the study.
- Enrolled in an investigational study where product was applied to the proposed study site within 30 days of the screening visit
- The skin area affected by radiation requires treatment with a concomitant medication or product (if applicable)
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Evaluation of Feasibility in the Prophylaxis of Radiation Dermatitis Severity in Cancer Patients
To compare radiation dermatitis severity in irradiated skin protected by an agent verses uncovered skin based on photographs and track patient reported outcomes with use of the agent.
- Conditions
- Radiation Dermatitis
- Being tested
- StrataXRT
- Medical subject headings
- Radiodermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StrataXRTDrug
Patients will be asked to start topical application of their allocated topical preparation on the area of skin that will be irradiated at the onset of radiation therapy, every day until skin symptoms subside (see patient information pamphlet). Apply twice per day and can be reapplied as skin symptoms arise or as needed. The amount of StrataXRT provided to each patient will be recorded throughout treatment.
| Study group | Role | What they receive |
|---|---|---|
| Group 1- StrataXRT | Not described Receives: Drug: StrataXRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare radiation dermatitis severity in irradiated skin protected by an agent versus uncovered skin (internal control) based on photographs.
Measured: First day of treatment and last day of radiation therapy (approximately 6 weeks, but will vary per patient) +/- 4 days
Secondary outcomes (1)
Patient reported outcomes
Patients will be asked to complete a survey at the end of study that will ask them to provide feedback on the agent used during their treatment.
Measured: Upon study completion, on average 6 weeks, but will vary per patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study start22 Jun 2020
- Primary completion30 Jan 2024
- Study completion30 Jan 2024
Why it stopped: slow accrual; investigator retired
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 Mayo ClinicThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ivy Petersen, MD, Principal investigator, Mayo Clinic Radiation Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04715386
- Sponsor's protocol ID
- 19-007541
- Other IDs
- NCI-2023-00638
- Status last verified
- Feb 2024
- First submitted
- 17 Jun 2020
- Last updated
- 9 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Feasibility in the Prophylaxis of Radiation Dermatitis Severity in Cancer Patients
- ClinicalTrials.gov ID
- NCT04715386
- Acronym / sponsor ID
- 19-007541
- Conditions
- Radiation Dermatitis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: slow accrual; investigator retired
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 22 Jun 2020 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 20 Jan 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.
To compare radiation dermatitis severity in irradiated skin protected by an agent verses uncovered skin based on photographs and track patient reported outcomes with use of the agent.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1- StrataXRT | – | Drug: StrataXRT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with head and neck cancer
Key inclusion criteria (6 listed)
- Age ≥ 18years
- Undergoing external beam radiotherapy for head/neck cancer at Mayo Clinic Rochester campus.
- Note: patients undergoing concurrent chemotherapy are eligible.
- Able to provide informed written consent
- Willing to consent for photography of radiation field
Key exclusion criteria (5 listed)
- Patients with active rash, pre-existing dermatitis, lupus, tattoos, scleroderma or other conditions within the treatment area that may make skin assessment for the study difficult per treating physician discretion.
- Patients with known allergic and other systemic skin diseases even if not directly affecting irradiated fields.
- Any medical condition that in the opinion of the investigator should exclude him/her from participating in the study.
- Enrolled in an investigational study where product was applied to the proposed study site within 30 days of the screening visit
- The skin area affected by radiation requires treatment with a concomitant medication or product (if applicable)
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 |
|---|---|---|
| StrataXRTPatients will be asked to start topical application of their allocated topical preparation on the area of skin that will be irradiated at the onset of radiation therapy, every day until skin symptoms subside (see patient information pamphlet). Apply twice per day and can be reapplied as skin symptoms arise or as needed. The amount of StrataXRT provided to each patient will be recorded throughout treatment. | Drug | Group 1- StrataXRT |
Primary outcome
To compare radiation dermatitis severity in irradiated skin protected by an agent versus uncovered skin (internal control) based on photographs.
Time frame: First day of treatment and last day of radiation therapy (approximately 6 weeks, but will vary per patient) +/- 4 days
1 secondary outcome
Patient reported outcomes
Time frame: Upon study completion, on average 6 weeks, but will vary per patient
Results and safety
The study was stopped early (reason given: slow accrual; investigator retired). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Ivy Petersen, MD principal investigator
Mayo Clinic Radiation Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Radiation Dermatitis, run by Mayo Clinic 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 6 inclusion and 5 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 9 Feb 2024. 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: slow accrual; investigator retired). 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?
To compare radiation dermatitis severity in irradiated skin protected by an agent versus uncovered skin (internal control) based on photographs. (time frame: First day of treatment and last day of radiation therapy (approximately 6 weeks, but will vary per patient) +/- 4 days). 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 9 Feb 2024.