Phase 3
N=132
Modified Dakin's Solution in Reducing Radiation-Induced Dermatitis in Patients With Head and Neck Cancer Undergoing Radiation Therapy
Head and Neck Carcinoma · Radiation-Induced Dermatitis
Bottom Line
View on ClinicalTrials.gov: NCT02369835 ↗Enrolled (actual)
132
Serious AEs
53.0%
Results posted
Sep 2019
Primary outcome: Primary: Radiation Dermatitis — 34; 36 Participants — p=.8872
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Dakin's solution (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Jul 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Radiation Dermatitis |
34; 36 | .8872 |
| SECONDARY Time to Grade E Radiation Dermatitis |
— | — |
| SECONDARY Pain Associated With Radiation Dermatitis |
— | — |
Summary
This randomized phase 3 trial studies how well modified Dakin's solution works in reducing radiation-induced dermatitis, a common skin reaction to radiation therapy, in patients with head and neck cancer undergoing radiation therapy. Modified Dakin's solution may reduce inflammation in the body, which may prevent or reduce dermatitis after radiation therapy.
Radiation therapy in this study is regulatory medical care based on the patient's needs and the radiation oncologist's judgment. It is not possible nor necessary to explicitly define the dose or duration of treatment.
Eligibility Criteria
Inclusion Criteria
- Head and neck cancer who plan to undergo radiation therapy to the head and neck region
- At least 18 years of age
- Able to understand and the willingness to sign a written informed consent document.
Exclusion Criteria
- Prior radiation therapy to the head and neck region or prior chemotherapy for head and neck cancer (induction chemotherapy NOT excluded)
- The physician-approved radiation treatment plan indicates a maximum prescription dose of less than 45 Gy
- Scleroderma or discoid lupus
Data sourced from ClinicalTrials.gov (NCT02369835). 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.