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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Stanford University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT02203565
First received: July 28, 2014
Last updated: NA
Last verified: July 2014
History: No changes posted
  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
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: Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percent of patients who are able to complete the recommended application on a daily basis [ Time Frame: Up to 6 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Descriptive analyses will be used.


Estimated Enrollment: 20
Study Start Date: July 2014
Estimated 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:

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

Ages Eligible for Study:   18 Years and older
Genders 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
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 ClinicalTrials.gov identifier: NCT02203565

Locations
United States, California
Stanford University Hospitals and Clinics Recruiting
Stanford, California, United States, 94305
Contact: Grant Ognibene    650-736-0921    grantog@stanford.edu   
Principal Investigator: Kathleen C. Horst         
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Kathleen Horst Stanford University Hospitals and Clinics
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT02203565     History of Changes
Other Study ID Numbers: BRS0039, NCI-2014-01551, 29833, BRS0039, P30CA124435
Study First Received: July 28, 2014
Last Updated: July 28, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 20, 2014