N/A
N=25
Topical Keratin in Treating Radiation Dermatitis in Patients With Breast Cancer
Breast Carcinoma · Radiation-Induced Dermatitis
Bottom Line
View on ClinicalTrials.gov: NCT03374995 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcome: Primary: Incidence of Early Adverse Skin Reactions (EASRs) — 13; 10; 4; 6 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Best Practice (Other); Quality-of-Life Assessment (Other); Topical Keratin (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Nov 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Early Adverse Skin Reactions (EASRs) |
13; 10; 4; 6; 1; 0 | — |
| PRIMARY Change in Quality of Life |
0.31; 2.73; 0.77; 1.64; 2.23; 1.91 | — |
| PRIMARY Physician Observed Improvement in Skin Appearance |
0.00; 0.00; 0.15; 0.09; 0.62; 0.55 | — |
| PRIMARY Number of Participants Reported Change in Skin Appearance Using the Dermatology Quality of Life Index Scale |
2; 4; 6; 6; 8; 8 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03374995). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.