Symptoms and General Pathology

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Fibrosis

Head and Neck Neoplasms

Radiation Fibrosis Syndrome

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All Drugs and Chemicals

Superoxide Dismutase

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.

Topical Sodermix Dismutase in the form of Sodermix (SOD) will be applied twice daily, of half dollar application for 12 weeks to fibrosed area.

Topical Sodermix Dismutase in the form of Sodermix (SOD)

Placebo or cetaphil cream will be applied twice daily, of half dollar size for 12 weeks to fibrosed area.

Placebo

William C Spanos, MD

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.

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.

Study of Topical Superoxide Dismutase to Treat Radiation Induced Fibrosis

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

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

1. - Very minor annoyance-occasional minor twinges
2. - Minor annoyance-occasional, does not interfere with activities
3. - Annoying enough to be distracting
4. - Can be ignored if you are really involved in your work, but still distracting,
5. - Can't be ignored for more than 30 minutes. Interrupts some activities.
6. - Can't be ignored for any length of time, but you can still go to work and participate in social activities.
7. - Make it difficult to concentrate, interferes with sleep, you can still function with effort, prevents doing daily activities
8. - Physical activity severely limited. You can read and converse with effort. Hard to do anything
9. - Unable to do anything, Can't bear the pain
10. - 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.

Sanford Health

During each study visit and telephone interview, scheduled weekly, subjects will be asked open-ended questions to elicit any medically related changes in their well-being.

Patients with measurable radiation induced fibrosis of the neck. Patients will be randomized to Topical Sodermix Dismutase in the form of Sodermix(SOD)

Topical Sodermix Dismutase in the form of Sodermix (SOD): Topical Sodermix Dismutase in the form of Sodermix (SOD) will be applied twice daily, of half dollar application for 12 weeks to fibrosed area.

Topical Sodermix Dismutase

Cetaphil cream

Placebo: Placebo or cetaphil cream will be applied twice daily, of half dollar size for 12 weeks to fibrosed area.

Placebo Group

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Dr Chad Spanos MD

All subjects randomized between August 2012 and May 2013.

Improvement in Neck Fibrosis

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.

Topical Sodermix Dismutase in the form of Sodermix (SOD): Topical Sodermix Dismutase in the form of Sodermix (SOD) will be applied twice daily, of half dollar application for 12 weeks to fibrosed area.

The analysis population are those who filled out the Quality of Life questionnaire at baseline and 3 months.

Determine the Quality of Life Impact From Radiation Related Fibrosis in Head and Neck Cancer Patients

Looking at the difference in pain change over time. The null hypothesis is there was no difference between the two treatment groups.

All patients who had a pre-treatment and post-treatment pain score.

Determine the Pain From Radiation Related Fibrosis in Head and Neck Cancer Patients

Looking at the difference in range of motion change over time. The null hypothesis is there was no difference between the two treatment groups.

Patients with pre-treatment and post-treatment measures.

Spots Global Cancer Trial Database for radiation induced fibrosis to the head and neck