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

Phase 2

Completed

• Conditions: Breast Cancer; Skin Reactions Secondary to Radiation Therapy
• Interventions: Drug: Dakin's solution; Radiation: radiation therapy; Other: questionnaire administration; Other: laboratory biomarker analysis

• Registration Number: NCT02203565
• Lead Sponsor: Stanford University

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.

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-28
• Study First Submitted QC: 2014-07-28
• Study First Posted: 2014-07-30
• Primary Completion: 2016-07-07
• Study Completion: 2016-07-07
• Results First Submitted: 2017-05-22
• Status Verified: 2017-06
• Results First Submitted QC: 2017-06-26
• Last Update Submitted: 2017-06-26
• Results First Posted: 2017-07-26
• Last Update Posted: 2017-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Supportive care (Dakin's solution, radiation therapy)	questionnaire administration	Patients apply Dakin's solution topically daily over 10 minutes within 60 minutes of radiation therapy for up to 6 weeks.
Supportive care (Dakin's solution, radiation therapy)	Dakin's solution	Patients apply Dakin's solution topically daily over 10 minutes within 60 minutes of radiation therapy for up to 6 weeks.
Supportive care (Dakin's solution, radiation therapy)	laboratory biomarker analysis	Patients apply Dakin's solution topically daily over 10 minutes within 60 minutes of radiation therapy for up to 6 weeks.
Supportive care (Dakin's solution, radiation therapy)	radiation therapy	Patients apply Dakin's solution topically daily over 10 minutes within 60 minutes of radiation therapy for up to 6 weeks.

Primary Outcome Measures

Name	Time	Method
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	Baseline to up to 6 weeks after completion of 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

Trial Locations

Locations (1)

Stanford University, School of Medicine; 🇺🇸 Stanford, California, United States