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

This study is ongoing, but not recruiting participants.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Stanford University Identifier:
First received: July 28, 2014
Last updated: September 21, 2016
Last verified: September 2016
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.

Condition Intervention
Breast Cancer Skin Reactions Secondary to Radiation Therapy Drug: Dakin's solution Radiation: radiation therapy Other: questionnaire administration Other: laboratory biomarker analysis

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Pilot Study to Investigate the Impact of Hypochlorite in the Prevention of Radiation Dermatitis

Resource links provided by NLM:

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Percent change in number 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 ]

Secondary Outcome Measures:
  • Percent of patients who are able to complete the recommended application on a daily basis [ Time Frame: Up to 6 weeks ]
    Descriptive analyses will be used.

  • Percent of patients who experience pain or discomfort during and after radiotherapy assessed by the Brief Pain Inventory [ Time Frame: Up to 6 weeks after completion of therapy ]
    Descriptive analyses will be used.

Enrollment: 20
Study Start Date: July 2014
Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Dakin's solution
Applied topically
Other Names:
  • aqueous solution of sodium hypochlorite
  • Dakin's fluid
Radiation: radiation therapy
Undergo radiation therapy
Other Names:
  • irradiation
  • radiotherapy
  • therapy, radiation
Other: questionnaire administration
Ancillary studies
Other: laboratory biomarker analysis
Optional correlative studies

Detailed Description:


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.


I. To assess the feasibility of daily application of the hypochlorite solution (Dakin's solution), and to assess levels of pain during radiotherapy treatment.


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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02203565

United States, California
Stanford University, School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
National Cancer Institute (NCI)
Principal Investigator: Kathleen Horst Stanford University Hospitals and Clinics
  More Information

Responsible Party: Stanford University Identifier: NCT02203565     History of Changes
Other Study ID Numbers: BRS0039
NCI-2014-01551 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
BRS0039 ( Other Identifier: Stanford University Hospitals and Clinics )
P30CA124435 ( US NIH Grant/Contract Award Number )
Study First Received: July 28, 2014
Last Updated: September 21, 2016

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Radiation Injuries
Wounds and Injuries
Pharmaceutical Solutions
Sodium Hypochlorite
Anti-Infective Agents processed this record on June 28, 2017