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

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).

SECONDARY OBJECTIVES:

I. Time to development of grade 3 radiation dermatitis. II. Quality-of-life and pain levels
(as assessed by the Modified Brief Pain Inventory) in the control arm versus the experimental
arm.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I (EXPERIMENTAL): Patients apply modified Dakin's solution topically to skin that will be
irradiated for 10 minutes within 3 hours before each radiation treatment.

ARM II (CONTROL): Patients apply placebo solution topically to skin that will be irradiated
for 10 minutes within 3 hours before each radiation treatment.

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

Inclusion Criteria:

- Patients with head and neck cancer who plan to undergo radiation therapy to the head
and neck region

- Patients must be at least 18 years of age

- Patients must be able to understand and the willingness to sign a written informed
consent document.

Exclusion Criteria:

- Patients with prior radiation therapy to the head and neck region or prior
chemotherapy for head and neck cancer (induction chemotherapy NOT excluded)

- Patients whose physician-approved radiation treatment plan indicates a maximum
prescription dose of less than 45 Gy

- Patients with scleroderma or discoid lupus