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

NCT02203565 | Completed Phase 2 Results DMC FDA Drug

• 4 other identifiers: BRS0039NCI-2014-01551IRB-29833P30CA124435
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Skin Reactions Secondary to Radiation Therapy

Outcome Measures

Primary Outcomes (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

  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

  Baseline to up to 6 weeks after completion of therapy

Study Arms (1)

Supportive care (Dakin's solution, radiation therapy)

EXPERIMENTAL

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; Radiation: radiation therapy; Other: questionnaire administration; Other: laboratory biomarker analysis

Interventions

Dakin's solution DRUG

Applied topically

Also known as: aqueous solution of sodium hypochlorite, Dakin's fluid

Supportive care (Dakin's solution, radiation therapy)

radiation therapy RADIATION

Undergo radiation therapy

Also known as: irradiation, radiotherapy, therapy, radiation

Supportive care (Dakin's solution, radiation therapy)

questionnaire administration OTHER

Ancillary studies

Supportive care (Dakin's solution, radiation therapy)

laboratory biomarker analysis OTHER

Optional correlative studies

Supportive care (Dakin's solution, radiation therapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Stanford University, School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Sodium Hypochlorite; Radiotherapy; Radiation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Hypochlorous Acid; Chlorine Compounds; Inorganic Chemicals; Oxides; Oxygen Compounds; Sodium Compounds; Therapeutics; Physical Phenomena

Results Point of Contact

• Title: Dr. Kathleen Horst
• Organization: Stanford University School of Medicine

kateh@stanford.edu

6507256009

Study Officials

• Kathleen Horst

  Stanford University Hospitals and Clinics

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Radiation Oncology

Study Record Dates

• First Submitted: July 28, 2014
• First Posted: July 30, 2014
• Study Start: July 1, 2014
• Primary Completion: July 7, 2016
• Study Completion: July 7, 2016
• Last Updated: July 26, 2017
• Results First Posted: July 26, 2017

Record last verified: 2017-06

Locations

US (1)