drugset / Trial / NCT02369835
Modified Dakin's Solution in Reducing Radiation-Induced Dermatitis in Patients With Head and Neck Cancer Undergoing Radiation Therapy
RandomizedParallel-groupTriple-blindSupportive care
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.
Timeline
- Start
- 2015-05
- Primary completion
- 2018-07-18
- Completion
- 2018-07-18
Outcome
Missed primary endpoint
registry analysis (other test); Arm I (Modified Dakin's Solution) vs Arm II (Placebo); p = .8872; Chi-squared NCT02369835 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sodium Hypochlorite | Unknown | 0.005 % | Topical |
| Subject | Sodium Hypochlorite | Unknown | 0.01 % | Topical |