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Clinical Trial Summary

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.


Clinical Trial Description

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 Design


Related Conditions & MeSH terms

  • Fibrosis
  • Radiation Induced Fibrosis to the Head and Neck

NCT number NCT01771991
Study type Interventional
Source Sanford Health
Contact
Status Completed
Phase N/A
Start date August 2012
Completion date June 2013