Topical Superoxide Dismutase For the Treatment of Radiation Induced Fibrosis in the Head and Neck Cancer Patient
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Improvement in neck fibrosis
Improvement in fibrosis as defined as a one point improvement on the fibrosis scale.
William H Avery, DO
Sanford Health/Sanford Clinic ENT
United States: Food and Drug Administration
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