Trials / Completed
CompletedNCT02203565
Dakin's Solution in Preventing Radiation Dermatitis in Patients With Breast Cancer Undergoing Radiation Therapy
Pilot Study to Investigate the Impact of Hypochlorite in the Prevention of Radiation Dermatitis
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- Stanford University · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
PRIMARY OBJECTIVES: I. To determine the percent change in women who experience grade 3 or 4 radiation dermatitis as defined by the Stanford Radiation Dermatitis Scoring System during radiation treatment for breast cancer compared to historical experience using standard skin care. SECONDARY OBJECTIVES: I. To assess the feasibility of daily application of the hypochlorite solution (Dakin's solution), and to assess levels of pain during radiotherapy treatment. OUTLINE: Patients apply Dakin's solution topically daily over 10 minutes within 60 minutes of radiation therapy for up to 6 weeks. After completion of study treatment, patients are followed up at 4-6 weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Dakin's solution | Applied topically |
| RADIATION | radiation therapy | Undergo radiation therapy |
| OTHER | questionnaire administration | Ancillary studies |
| OTHER | laboratory biomarker analysis | Optional correlative studies |
Timeline
- Start date
- 2014-07-01
- Primary completion
- 2016-07-07
- Completion
- 2016-07-07
- First posted
- 2014-07-30
- Last updated
- 2017-07-26
- Results posted
- 2017-07-26
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02203565. Inclusion in this directory is not an endorsement.