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

Breast Cancer Clinical Trial

Official title:

Pilot Study to Investigate the Impact of Hypochlorite in the Prevention of Radiation Dermatitis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02203565
• Other study ID #: BRS0039
• Secondary ID: NCI-2014-0155129
• Status: Active, not recruiting
• Phase: N/A
• First received: July 28, 2014
• Last updated: September 21, 2016
• Start date: July 2014

Study information

• Verified date: September 2016
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Dermatitis
• Radiodermatitis
• Skin Reactions Secondary to Radiation Therapy

Intervention

Drug:
• Dakin's solution
Applied topically

Radiation:
• radiation therapy
Undergo radiation therapy

Other:
• questionnaire administration
Ancillary studies
• laboratory biomarker analysis
Optional correlative studies

Locations

Country	Name	City	State
United States	Stanford University, School of Medicine	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		Baseline to up to 6 weeks after completion of therapy	No
Secondary	Percent of patients who are able to complete the recommended application on a daily basis	Descriptive analyses will be used.	Up to 6 weeks	No
Secondary	Percent of patients who experience pain or discomfort during and after radiotherapy assessed by the Brief Pain Inventory	Descriptive analyses will be used.	Up to 6 weeks after completion of therapy	No