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

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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University, School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: questionnaire administration; Ancillary studies; Radiation: radiation therapy; Undergo radiation therapy; Other Names: irradiation; radiotherapy; therapy, radiation; Other: laboratory biomarker analysis; Optional correlative studies; Drug: Dakin's solution; Applied topically; Other Names: Dakin's fluid; aqueous solution of sodium hypochlorite

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

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Kathleen Horst, Stanford University Hospitals and Clinics

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): July 7, 2016
• Study Completion (Actual): July 7, 2016

Study Registration Dates

• First Submitted: July 28, 2014
• First Submitted That Met QC Criteria: July 28, 2014
• First Posted (Estimate): July 30, 2014

Study Record Updates

• Last Update Posted (Actual): July 26, 2017
• Last Update Submitted That Met QC Criteria: June 26, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Wounds and Injuries; Breast Diseases; Radiation Injuries; Breast Neoplasms; Dermatitis; Radiodermatitis; Anti-Infective Agents; Disinfectants; Pharmaceutical Solutions; Sodium Hypochlorite; Eusol
• Other Study ID Numbers: BRS0039 (Other Identifier: OnCore); P30CA124435 (U.S. NIH Grant/Contract); NCI-2014-01551 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); IRB-29833

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No