COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02203565
Recruitment Status : Completed
First Posted : July 30, 2014
Results First Posted : July 26, 2017
Last Update Posted : July 26, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Kathleen Horst, Stanford University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Skin Reactions Secondary to Radiation Therapy Drug: Dakin's solution Radiation: radiation therapy Other: questionnaire administration Other: laboratory biomarker analysis Phase 2

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Pilot Study to Investigate the Impact of Hypochlorite in the Prevention of Radiation Dermatitis
Study Start Date : July 2014
Actual Primary Completion Date : July 7, 2016
Actual Study Completion Date : July 7, 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.
 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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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



Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02203565


Locations
Layout table for location information
United States, California
Stanford University, School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Kathleen Horst Stanford University Hospitals and Clinics
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Kathleen Horst, Assistant Professor of Radiation Oncology, Stanford University
ClinicalTrials.gov Identifier: NCT02203565    
Other Study ID Numbers: BRS0039
NCI-2014-01551 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
IRB-29833
BRS0039 ( Other Identifier: OnCore )
P30CA124435 ( U.S. NIH Grant/Contract )
First Posted: July 30, 2014    Key Record Dates
Results First Posted: July 26, 2017
Last Update Posted: July 26, 2017
Last Verified: June 2017

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Dermatitis
Radiodermatitis
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
 Radiation Injuries
Wounds and Injuries
Sodium Hypochlorite
Eusol
Pharmaceutical Solutions
Disinfectants
Anti-Infective Agents