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

Phase 2CompletedNCT02203565

Stanford University20 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Breast Cancer Skin Reactions Secondary to Radiation Therapy

Interventions

Dakin's solutionDRUG

Applied topically

radiation therapyRADIATION

Undergo radiation therapy

questionnaire administrationOTHER

Ancillary studies

laboratory biomarker analysis

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Stanford University, School of Medicine

Stanford, California, United States

Outcomes

Primary Outcomes

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

Time frame: Baseline to up to 6 weeks after completion of therapy

Data from ClinicalTrials.gov

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