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

Primary Purpose

Breast Cancer, Skin Reactions Secondary to Radiation Therapy

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Dakin's solution
radiation therapy
questionnaire administration
laboratory biomarker analysis
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford University, School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Supportive care (Dakin's solution, radiation therapy)

Arm Description

Patients apply Dakin's solution topically daily over 10 minutes within 60 minutes of radiation therapy for up to 6 weeks.

Outcomes

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
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

Secondary Outcome Measures

Full Information

First Posted
July 28, 2014
Last Updated
June 26, 2017
Sponsor
Stanford University
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02203565
Brief Title
Dakin's Solution in Preventing Radiation Dermatitis in Patients With Breast Cancer Undergoing Radiation Therapy
Official Title
Pilot Study to Investigate the Impact of Hypochlorite in the Prevention of Radiation Dermatitis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
July 7, 2016 (Actual)
Study Completion Date
July 7, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Skin Reactions Secondary to Radiation Therapy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Supportive care (Dakin's solution, radiation therapy)
Arm Type
Experimental
Arm Description
Patients apply Dakin's solution topically daily over 10 minutes within 60 minutes of radiation therapy for up to 6 weeks.
Intervention Type
Drug
Intervention Name(s)
Dakin's solution
Other Intervention Name(s)
aqueous solution of sodium hypochlorite, Dakin's fluid
Intervention Description
Applied topically
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Other Intervention Name(s)
irradiation, radiotherapy, therapy, radiation
Intervention Description
Undergo radiation therapy
Intervention Type
Other
Intervention Name(s)
questionnaire administration
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Optional correlative studies
Primary Outcome Measure Information:
Title
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
Description
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
Time Frame
Baseline to up to 6 weeks after completion of therapy

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen Horst
Organizational Affiliation
Stanford University Hospitals and Clinics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University, School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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