Phase 2
N=20
Dakin's Solution in Preventing Radiation Dermatitis in Patients With Breast Cancer Undergoing Radiation Therapy
Breast Cancer · Skin Reactions Secondary to Radiation Therapy
Bottom Line
View on ClinicalTrials.gov: NCT02203565 ↗Enrolled (actual)
20
Serious AEs
15.0%
Results posted
Jul 2017
Primary outcome: Primary: Percent of Women Who Develop Grade 3 or 4 Radiation Dermatitis (as Defined by the Stanford Radiation Dermatitis Scoring System) During a Course of Radiation Therapy — 6 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Dakin's solution (Drug); radiation therapy (Radiation); questionnaire administration (Other); laboratory biomarker analysis (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Stanford University
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Women Who Develop Grade 3 or 4 Radiation Dermatitis (as Defined by the Stanford Radiation Dermatitis Scoring System) During a Course of Radiation Therapy |
6 | — |
Summary
This pilot clinical trial studies Dakin's solution in preventing radiation dermatitis in patients with breast cancer undergoing radiation therapy. Radiation dermatitis is a skin condition in which the affected skin becomes painful, red, itchy, and blistered. Dakin's solution may help reduce dermatitis caused by radiation therapy.
Eligibility Criteria
Inclusion Criteria
- Women with breast cancer who plan to undergo radiation therapy to the breast or chest wall
- Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria
- Women with scleroderma or discoid lupus
- Women with inflammatory breast cancer as evidenced by clinical assessment
- Women with breast cancer involving the skin
- Women who have undergone prior radiotherapy to the chest wall and/or breast
Data sourced from ClinicalTrials.gov (NCT02203565). 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.