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

June 26, 2017 updated by: Kathleen Horst, Stanford University

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Kathleen Horst, Stanford University Hospitals and Clinics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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