NCT01771991

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Sanford Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Radiation Induced Fibrosis to the Head and Neck

Interventions

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

Timeline

• Start date: 2012-08-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2013-01-21
• Last updated: 2019-04-05
• Results posted: 2015-04-24

Locations

1 site across 1 country: United States