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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2016-07-07

Brief Summary

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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.

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Detailed Description

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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

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Breast Cancer Skin Reactions Secondary to Radiation Therapy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Supportive care (Dakin's solution, radiation therapy)

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

Group Type EXPERIMENTAL

Dakin's solution

Intervention Type DRUG

Applied topically

radiation therapy

Intervention Type RADIATION

Undergo radiation therapy

questionnaire administration

Intervention Type OTHER

Ancillary studies

laboratory biomarker analysis

Intervention Type OTHER

Optional correlative studies

Interventions

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Dakin's solution

Applied topically

Intervention Type DRUG

radiation therapy

Undergo radiation therapy

Intervention Type RADIATION

questionnaire administration

Ancillary studies

Intervention Type OTHER

laboratory biomarker analysis

Optional correlative studies

Intervention Type OTHER

Other Intervention Names

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aqueous solution of sodium hypochlorite Dakin's fluid irradiation radiotherapy therapy, radiation

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No