Modified Dakin's Solution in Reducing Radiation-Induced Dermatitis in Patients With Head and Neck Cancer Undergoing Radiation Therapy

NCT02369835 | Completed Phase 3 Results DMC FDA Drug

• 3 other identifiers: IRB-32439NCI-2015-00176ENT0042
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 2

Brief Summary

This randomized phase 3 trial studies how well modified Dakin's solution works in reducing radiation-induced dermatitis, a common skin reaction to radiation therapy, in patients with head and neck cancer undergoing radiation therapy. Modified Dakin's solution may reduce inflammation in the body, which may prevent or reduce dermatitis after radiation therapy. Radiation therapy in this study is regulatory medical care based on the patient's needs and the radiation oncologist's judgment. It is not possible nor necessary to explicitly define the dose or duration of treatment.

Conditions

Head and Neck Carcinoma; Radiation-Induced Dermatitis

Outcome Measures

Primary Outcomes (1)

• Radiation Dermatitis

  Participants were assessed for radiation dermatitis on the arms according to the Stanford Radiation Dermatitis Scoring System (SRDSS), at baseline and through their treatment course. The outcome is reported by treatment group as the number and proportion of participants that experience SRDSS Grade E or greater radiation dermatitis through 10 weeks after completion of radiation treatment, a number without dispersion. SRDSS, by grade: * A. No skin change * B. Faint, barely detectable erythema * C. Follicular rash, hyperpigmentation, evolving erythema * D. Dry desquamation, brisk erythema * E. Moist desquamation * F. Bleeding, ulceration, and/or infection SRDSS Grade E is roughly equivalent to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 Grade 3 radiation dermatitis, "Moist desquamation in areas other than skin folds and creases; bleeding induced by minor trauma or abrasion"

  From first radiation treatment up to 10 weeks after completion of radiation treatment. Because much of the study data was not provided by the prior investigator to the current Responsible Party, it is not possible to be more precise than stated.

Secondary Outcomes (2)

• Time to Grade E Radiation Dermatitis

  up to 12 weeks (estimated)

• Pain Associated With Radiation Dermatitis

  3 to 12 weeks after completion of radiation treatment

Study Arms (2)

Arm I (modified Dakin's solution)

EXPERIMENTAL

Participants apply modified Dakin's solution (0.005% to 0.010%) topically to the skin of the arm up to 3 hours in advance of each radiation treatment.

Drug: Dakin's solution

Arm II (placebo)

PLACEBO COMPARATOR

Participants apply placebo solution (saline) topically to the skin of the arm up to 3 hours in advance of each radiation treatment.

Other: Placebo

Interventions

Dakin's solution DRUG

Apply modified Dakin's solution (0.005 to 0.01%) topically

Also known as: Sodium hypochlorite in aqueous solution, Dakin's fluid, Liquid bleach

Arm I (modified Dakin's solution)

Placebo OTHER

Applied topically

Also known as: PLCB

Arm II (placebo)

Eligibility Criteria

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

You may qualify if:

• Head and neck cancer who plan to undergo radiation therapy to the head and neck region
• At least 18 years of age
• Able to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• Prior radiation therapy to the head and neck region or prior chemotherapy for head and neck cancer (induction chemotherapy NOT excluded)
• The physician-approved radiation treatment plan indicates a maximum prescription dose of less than 45 Gy
• Scleroderma or discoid lupus

Sponsors & Collaborators

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

Study Sites (2)

Stanford Cancer Center South Bay

San Jose, California, 95124, United States

Location

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Radiodermatitis

Interventions

Sodium Hypochlorite

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Radiation Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Hypochlorous Acid; Chlorine Compounds; Inorganic Chemicals; Oxides; Oxygen Compounds; Sodium Compounds

Results Point of Contact

• Title: Beth Beadle
• Organization: Stanford University

bbeadle@stanford.edu

650-723-6194

Study Officials

• Beth Beadle

  Stanford University Hospitals and Clinics

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Radiation Oncology

Study Record Dates

• First Submitted: February 17, 2015
• First Posted: February 24, 2015
• Study Start: May 1, 2015
• Primary Completion: July 18, 2018
• Study Completion: July 18, 2018
• Last Updated: January 30, 2024
• Results First Posted: September 17, 2019

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)