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

Study Overview
=================
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.

Detailed 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.

Official Title
-----------------
A Randomized Study of Topical Dilute Hypochlorite (Modified Dakin's Solution) Treatment for the Prevention of Radiation Dermatitis in Head and Neck Cancer

Conditions
-----------------
Head and Neck Carcinoma, Radiation-Induced Dermatitis

Intervention / Treatment
-----------------
* Drug: Dakin's solution
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (modified Dakin's solution)<br>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<br>* Apply modified Dakin's solution (0.005 to 0.01%) topically<br>* Other names: Liquid bleach;|
| Placebo Comparator: Arm II (placebo)<br>Participants apply placebo solution (saline) topically to the skin of the arm up to 3 hours in advance of each radiation treatment. | Other: Placebo<br>* Applied topically<br>* Other names: PLCB;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Grade E 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 time that SRDSS Grade E radiation dermatitis developed was noted. The outcome is reported by treatment group as the mean time to development of SRDSS Grade E radiation dermatitis, with standard deviation. 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. Additional information describing this outcome is not available. | up to 12 weeks (estimated) | 
| Pain Associated With Radiation Dermatitis | Quality of life was assessed as pain associated with radiation dermatitis. Assessments were baseline and through treatment follow-up 3 to 12 weeks after completion of radiation treatment. The assessment was to be conducted with a Modified Brief Pain Inventory (MBPI), a 13-question survey with responses ranging from 0 to 10, and an overall score of 0 to 130. A higher score indicates more pain and less quality of life. The outcome was to be reported by treatment group as the mean score with standard deviation. Additional information describing this outcome is not available. | 3 to 12 weeks after completion of radiation treatment |