Topical Keratin in Treating Radiation Dermatitis in Patients With Breast Cancer (NCT03374995) | Clinical Trial Compass
CompletedNot Applicable
Topical Keratin in Treating Radiation Dermatitis in Patients With Breast Cancer
United States25 participantsStarted 2018-03-26
Plain-language summary
This randomized pilot clinical trial studies how well topical keratin works in treating radiation dermatitis in patients with breast cancer. Radiation dermatitis is a skin condition that is a common side effect of radiation therapy. The affected skin becomes painful, red, itchy, and blistered. Topical keratin may help to improve skin appearance and hydration in patients with breast cancer.
Who can participate
Age range
18 Years – 70 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosis of breast cancer, received chemotherapy, and scheduled to receive 4 to 6 weeks of radiation therapy (radiation protocol of 42 Gy+)
* Area to be irradiated representing 1-10% of total body surface area (TBSA)
* Able and willing to sign protocol consent form
* Able and willing to document symptoms and treatment details as often as needed, not to exceed daily notes
* Able and willing to have photographs of the affected area taken regularly
Exclusion Criteria:
* Women who are pregnant, lactating/nursing or plan to become pregnant
* Previous radiation therapy to the area to be treated with radiation therapy
* Receiving palliative radiation therapy
* Unhealed or infected surgical sites in the irradiation area
* Patients undergoing cytotoxic chemotherapy or concurrent Herceptin as part of overall treatment plan (tamoxifen/aromatase inhibitor allowed)
* Use of oral corticosteroids or topical corticosteroids in the irradiation area
* Use of Erbitux
* Autoimmune disease
* Skin disease in target irradiation area
* Smoker
* Known allergy to the standard of care or ingredients in KeraStat Cream
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Early Adverse Skin Reactions (EASRs)
Timeframe: Up to 4 weeks post-RT
2
Change in Quality of Life
Timeframe: Baseline to up to 7 weeks
3
Physician Observed Improvement in Skin Appearance
Timeframe: Baseline to up to 7 weeks
4
Number of Participants Reported Change in Skin Appearance Using the Dermatology Quality of Life Index Scale