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

Stanford University

Status and phase: Completed; Phase 3

Conditions: Head and Neck Carcinoma; Radiation-Induced Dermatitis

Treatments: Other: Placebo; Drug: Dakin's solution

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02369835

IRB-32439 (Other Identifier)

ENT0042 (Other Identifier)

NCI-2015-00176 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

PRIMARY OBJECTIVES:

I. To determine the proportion of patients who develop grade 3 radiation dermatitis (as defined by the Stanford Radiation Dermatitis Scoring System) as an adverse effect of radiation therapy or chemoradiation therapy for a head and neck cancer when initiating the use of prophylactic hypochlorite (HOCl) (modified Dakin's solution) at the start of therapy (experimental arm) compared to placebo (control arm).

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I (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.

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

At the time that Stanford Radiation Dermatitis Scoring System (SRDSS) Grade E radiation dermatitis develops, the participant will transition to standard management for radiation dermatitis. SRDSS, by grade, is as follows.

• 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."

After completion of study, patients are followed up at 6 to 10 weeks.

Enrollment: 132 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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132 participants in 2 patient groups, including a placebo group

Arm I (modified Dakin's solution)

Experimental group

Description:

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.

Treatment:

Drug: Dakin's solution

Arm II (placebo)

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo