Breast CancerNCT03519438
Evaluating Mepitel in Post-mastectomy Patients and the Role of the Skin Microbiome in Radiation Dermatitis
An observational study of Breast Cancer, run by Mayo Clinic at 1 site in United States.
Trial summary
The aim of this study is to examine alterations in the skin microbiome that occur during radiation therapy. The study design will examine changes secondary to ionizing radiation, and correlate these changes with the development and severity of radiation dermatitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Mepitel
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2018to 25 Nov 2019
- 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
- Adult, Older adult
Study population: post-mastectomy breast cancer patients
Who may be able to join
- Age ≥ 18 years.
- Histological confirmation of breast or chest wall malignancy
- Primary or recurrent disease eligible
- Post-mastectomy with or without reconstruction
- Undergoing unilateral external beam radiotherapy at the Mayo Clinic - Rochester, MN or Mayo Clinic - Eau Claire, WI
- Ability to complete questionnaire(s) by themselves or with assistance
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- Provide informed written consent
- Willing to consent for photography of radiation field
- Available to return to Mayo Clinic in within 6 weeks post-treatment for assessment
- Able to initiate thin film usage within first 3 days of the initiation of treatment
Who cannot join
- Documented history of adhesive or tape allergy
- Unable to provide written consent
- Patients with prior radiotherapy to any portion of the planned treatment site
- Brachytherapy patients
- Patients with active rash, pre-existing dermatitis, lupus, or scleroderma
- Gross dermal involvement at initiation of radiotherapy
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- Recent use of systemic or topical antibiotics or antifungal medications within 14 days of swab collection
- Recent use of any of the following within 14 days of swab collection:
- Systemic or topical steroids
- Use of systemic immunosuppressant drugs
- Use of ultraviolet light therapy
- Clinical evidence of infection that in the judgement of the principle investigator would interfere with proper assessment of the skin microbiome
- Prior organ or bone marrow transplant
- Current lactation
- Undergoing bilateral radiation
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Evaluating the Efficacy of Mepitel in Post-mastectomy Breast Cancer Patients, and Examining the Role of the Skin Microbiome in Radiation Dermatitis
The aim of this study is to examine alterations in the skin microbiome that occur during radiation therapy. The study design will examine changes secondary to ionizing radiation, and correlate these changes with the development and severity of radiation dermatitis. The goal is to improve understanding of the mechanism of radiation dermatitis.
- Conditions
- Breast Cancer
- Being tested
- Mepitel
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MepitelOther
Mepitel film will be placed on 3/4 of treatment field to protect from radiation dermatitis
| Study group | Role | What they receive |
|---|---|---|
| Lateral 3/4 of treatment field | placement of Mepitel on the lateral ¾ of the treatment field Receives: Other: Mepitel | |
| Medial 3/4 of treatment field | placement of Mepitel on the medial ¾ of the treatment field Receives: Other: Mepitel |
What is being measured
The primary outcome is the main question the study is designed to answer.
severity of radiation dermatitis in irradiated skin protected by Mepitel Film dressing versus uncovered skin receiving standard skin treatment
Measured: 12 weeks
changes in the skin microbiome that occur secondary to ionizing radiation including quantitative analysis of S. aureus
Measured: 12 weeks
changes in the skin microbiome of patients who use Mepitel including quantitative analysis of S. aureus
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2018
- Study start11 Apr 2018
- Primary completion25 Nov 2019
- Study completion25 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kimberly S. Corbin, Mayo Clinic
- Investigators
- Kimberly Corbin, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03519438
- Sponsor's protocol ID
- 17-001546
- Other IDs
- ROR1701
- Status last verified
- May 2022
- First submitted
- 26 Apr 2018
- Last updated
- 20 May 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy of Mepitel in Post-mastectomy Breast Cancer Patients, and Examining the Role of the Skin Microbiome in Radiation Dermatitis
- ClinicalTrials.gov ID
- NCT03519438
- Acronym / sponsor ID
- 17-001546
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 11 Apr 2018 (actual)
- Primary completion
- 25 Nov 2019 (actual)
- Study completion
- 25 Nov 2019 (actual)
- First posted
- 9 May 2018 (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 aim of this study is to examine alterations in the skin microbiome that occur during radiation therapy. The study design will examine changes secondary to ionizing radiation, and correlate these changes with the development and severity of radiation dermatitis. The goal is to improve understanding of the mechanism of radiation dermatitis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lateral 3/4 of treatment field | – | Other: Mepitelplacement of Mepitel on the lateral ¾ of the treatment field |
| Medial 3/4 of treatment field | – | Other: Mepitelplacement of Mepitel on the medial ¾ of the treatment field |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- post-mastectomy breast cancer patients
Key inclusion criteria (10 listed)
- Age ≥ 18 years.
- Histological confirmation of breast or chest wall malignancy
- Primary or recurrent disease eligible
- Post-mastectomy with or without reconstruction
- Undergoing unilateral external beam radiotherapy at the Mayo Clinic - Rochester, MN or Mayo Clinic - Eau Claire, WI
Key exclusion criteria (15 listed)
- Documented history of adhesive or tape allergy
- Unable to provide written consent
- Patients with prior radiotherapy to any portion of the planned treatment site
- Brachytherapy patients
- Patients with active rash, pre-existing dermatitis, lupus, or scleroderma
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 |
|---|---|---|
| MepitelMepitel film will be placed on 3/4 of treatment field to protect from radiation dermatitis | Other | Lateral 3/4 of treatment field, Medial 3/4 of treatment field |
Primary outcome
severity of radiation dermatitis in irradiated skin protected by Mepitel Film dressing versus uncovered skin receiving standard skin treatment
Time frame: 12 weeks
changes in the skin microbiome that occur secondary to ionizing radiation including quantitative analysis of S. aureus
Time frame: 12 weeks
changes in the skin microbiome of patients who use Mepitel including quantitative analysis of S. aureus
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2022.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
Kimberly Corbin, MD principal investigator
Mayo Clinic
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 Breast Cancer, 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 10 inclusion and 15 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: finished, as of the sponsor's last update on 20 May 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
severity of radiation dermatitis in irradiated skin protected by Mepitel Film dressing versus uncovered skin receiving standard skin treatment (time frame: 12 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 20 May 2022.