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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02203565
First Posted: July 30, 2014
Last Update Posted: July 26, 2017
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.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Kathleen Horst, Stanford University
  Purpose
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 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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Kathleen Horst, Stanford University:

Primary Outcome Measures:
  • 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



Enrollment: 20
Study Start Date: July 2014
Study Completion Date: July 7, 2016
Primary Completion Date: July 7, 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:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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
United States, California
Stanford University, School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
National Cancer Institute (NCI)
Investigators
Principal Investigator: Kathleen Horst Stanford University Hospitals and Clinics
  More Information

Responsible Party: Kathleen Horst, Assistant Professor of Radiation Oncology, Stanford University
ClinicalTrials.gov Identifier: NCT02203565     History of Changes
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 Submitted: July 28, 2014
First Posted: July 30, 2014
Results First Submitted: May 22, 2017
Results First Posted: July 26, 2017
Last Update Posted: July 26, 2017
Last Verified: June 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Breast Neoplasms
Dermatitis
Radiodermatitis
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Radiation Injuries
Wounds and Injuries
Pharmaceutical Solutions
Sodium Hypochlorite
Eusol
Disinfectants
Anti-Infective Agents