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

Stanford University

Status and phase: Completed; Phase 2

Conditions: Breast Cancer; Skin Reactions Secondary to Radiation Therapy

Treatments: Other: questionnaire administration; Drug: Dakin's solution; Radiation: radiation therapy; Other: laboratory biomarker analysis

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02203565

P30CA124435 (U.S. NIH Grant/Contract)

BRS0039 (Other Identifier)

IRB-29833

NCI-2014-01551 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Supportive care (Dakin's solution, radiation therapy)

Experimental group

Description:

Patients apply Dakin's solution topically daily over 10 minutes within 60 minutes of radiation therapy for up to 6 weeks.

Treatment:

Radiation: radiation therapy

Other: questionnaire administration

Drug: Dakin's solution

Other: laboratory biomarker analysis