Study of Topical Superoxide Dismutase to Treat Radiation Induced Fibrosis

Study Overview
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Brief Summary
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The purpose of this study is to determine if topical superoxide dismutase is an effective treatment of radiation related neck fibrosis, and to determine the quality of life impact from radiation related fibrosis in the head and neck cancer patients at Sanford Health.

Detailed Description
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The primary goal of this study is to evaluate the effect of topical Superoxide Dismutase (SOD) on the radiation induced fibrosis in head and neck cancer patients. A prospective, blinded, two group control design will be used with pretest and post test quality of life as well as objective fibrosis assessment. Patients will be randomized to alternatively receive topical SOD or placebo as instructed on twice daily use for 3 months. Pre and post treatment quality of life surveys and objective assessment will determine if the topical SOD improves neck fibrosis/function and global quality of life. This study will increase clinical trial awareness and participation while potentially improving the long term functional outcomes of head and neck cancer patients.

Official Title
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Topical Superoxide Dismutase For the Treatment of Radiation Induced Fibrosis in the Head and Neck Cancer Patient

Conditions
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Radiation Induced Fibrosis to the Head and Neck

Intervention / Treatment
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* Drug: Topical Sodermix Dismutase in the form of Sodermix (SOD)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: must have evidence of neck fibrosis previous radiation treatment to the neck for cancer age greater than or equal to 18 years life expectancy of greater than 12 weeks ability to understand the purpose of the study and the willingness to sign a written informed consent document. Exclusion Criteria: History of allergic reactions attributed to compounds of similar chemical or biologic composition to SOD or Cetaphil cram. any psychological, familial, sociological or geographical conditions that do not permit medical follow-up and compliance with the study protocol.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Topical Sodermix Dismutase<br>Patients with measurable radiation induced fibrosis of the neck. Patients will be randomized to applying Topical Sodermix Dismutase in the form of Sodermix(SOD) to the area of neck skin fibrosis twice a day for 12 weeks. | Drug: Topical Sodermix Dismutase in the form of Sodermix (SOD)<br>* Topical Sodermix Dismutase in the form of Sodermix (SOD) will be applied twice daily, of half dollar application for 12 weeks to fibrosed area.<br>* Other names: SOD;|
| Placebo Comparator: Placebo group<br>Cetaphil cream | Drug: Placebo<br>* Placebo or cetaphil cream will be applied twice daily, of half dollar size for 12 weeks to fibrosed area.<br>* Other names: Cetaphil cream;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in Neck Fibrosis | Number of participants with improvement in fibrosis as defined as a one point improvement on the fibrosis scale using the grading scale outlined in CTCAE 4.03, page 46. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the Quality of Life Impact From Radiation Related Fibrosis in Head and Neck Cancer Patients | Metrics are measured via analysis of Health Related Quality of Life questionnaire. Functional Assessment of Cancer Therapy for Head and Neck Cancer (FACT H&N) questionnaire was used to evaluate the quality of life in patient receiving treatment of head and neck cancer. Sub-categories of Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, Functional Well-Being, and Head & Neck Additional Concerns are included. Each category used a 5-point Likert scale ranged from 0 to 4 with 0= Not at all (no affect on daily activities) to 4=Very much (significant affect on daily activities). Sub-categories were not analyzed individually. All were summed together for total score. Analysis was done comparing baseline scores and end of treatment scores. Maximum scale total = 156 (answer of 4 to all items) Minimum scale total = 0 (answer of 0 to all items) | 3 months | 
| Determine the Pain From Radiation Related Fibrosis in Head and Neck Cancer Patients | Subjects use the numeric verbal pain rating scale (0-10 scale specified for neck region with 0 being no pain and 10 extreme pain). 0 - Pain free - Very minor annoyance-occasional minor twinges - Minor annoyance-occasional, does not interfere with activities - Annoying enough to be distracting - Can be ignored if you are really involved in your work, but still distracting, - Can't be ignored for more than 30 minutes. Interrupts some activities. - Can't be ignored for any length of time, but you can still go to work and participate in social activities. - Make it difficult to concentrate, interferes with sleep, you can still function with effort, prevents doing daily activities - Physical activity severely limited. You can read and converse with effort. Hard to do anything - Unable to do anything, Can't bear the pain - Bad as it could be, nothing else matters Differences between baseline scores and 3 month score | From baseline to 3 months. | 
| Cervical Spine Range of Motion | Determine the effect of the treatment on Range of Motion over time. Cervical spine rotation was measured by a physical therapist using a goniometer. A goniometer is an instrument that either measures an angle or allows an object to be rotated to a precise angular position. Results are documented in degrees. Baseline measurements were compared with post-treatment measurements. A larger post-treatment measure when compared to the baseline measurement would indicate an increase of the cervical spine range of motion. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fibrosis, radiation, neck, cancer, Sodermix