Study of Topical Superoxide Dismutase to Treat Radiation Induced 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.

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)

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

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.