Study Comparing Thin Dressings to Prevent Skin Inflammation in Breast Cancer Patients
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 16-004623
Sponsor Protocol Number: 16-004623
About this study
We are doing this research study to compare radiation dermatitis severity in exposed skin protected by a thin film dressing versus skin that is not protected during radiation treatment. We will also be comparing two types of film; a perforated thin film dressing versus the standard thin film.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria
- Age ≥ 18 years.
- Histological confirmation of breast or chest wall malignancy
- Initial or recurrent disease eligible
- Undergoing external beam radiotherapy at the Mayo Clinic Rochester campus
- Ability to complete questionnaire(s) by themselves or with assistance
- Provide informed written consent.
- Willing to consent for photography of radiation field.
- Patients undergoing concurrent chemotherapy are eligible.
- Available to return to Mayo Clinic in within 6 weeks post treatment for assessment
Exclusion Criteria
- Documented history of adhesive or tape allergy
- Unable to provide written consent
- Whole breast radiation dose of <45 Gy
- 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
- Male patients are not included in this study
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Ivy Petersen, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available