Dakin's Solution in Preventing Radiation Dermatitis in Patients With Breast Cancer Undergoing Radiation Therapy

Study Overview
=================
Brief 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.

Official Title
-----------------
Pilot Study to Investigate the Impact of Hypochlorite in the Prevention of Radiation Dermatitis

Conditions
-----------------
Breast Cancer, Skin Reactions Secondary to Radiation Therapy

Intervention / Treatment
-----------------
* Drug: Dakin's solution
* Radiation: radiation therapy
* Other: questionnaire administration
* Other: laboratory biomarker analysis


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supportive care (Dakin's solution, radiation therapy)<br>Patients apply Dakin's solution topically daily over 10 minutes within 60 minutes of radiation therapy for up to 6 weeks. | Drug: Dakin's solution<br>* Applied topically<br>* Other names: Dakin's fluid;Radiation: radiation therapy<br>* Undergo radiation therapy<br>* Other names: therapy, radiation;Other: questionnaire administration<br>* Ancillary studies<br>Other: laboratory biomarker analysis<br>* Optional correlative studies<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Stanford Radiation Dermatitis Scoring System: Grade Clinical finding 0 No skin change 1 Faint, barely detectable erythema 2 Follicular rash, hyperpigmentation, evolving erythema 3 Dry desquamation, brisk erythema 4 Moist desquamation 5 Bleeding, ulceration, and/or infection | Baseline to up to 6 weeks after completion of therapy |