Study of Topical Superoxide Dismutase to Treat Radiation Induced Fibrosis (Sodermix)
|Radiation Induced Fibrosis to the Head and Neck||Drug: Topical Sodermix Dismutase in the form of Sodermix (SOD) Drug: Placebo|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
|Official Title:||Topical Superoxide Dismutase For the Treatment of Radiation Induced Fibrosis in the Head and Neck Cancer Patient|
- Improvement in Neck Fibrosis [ Time Frame: 3 months ]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.
- Determine the Quality of Life Impact From Radiation Related Fibrosis in Head and Neck Cancer Patients [ Time Frame: 3 months ]Metrics are measured via analysis of pain and range of motion and Health Related Quality of Life questionnaire.
|Study Start Date:||August 2012|
|Study Completion Date:||June 2013|
|Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
Experimental: Topical Sodermix 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.
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.
Placebo Comparator: Placebo group
Placebo or cetaphil cream will be applied twice daily, of half dollar size for 12 weeks to fibrosed area.
Other Name: Cetaphil cream
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01771991
|United States, South Dakota|
|Sioux Falls, South Dakota, United States, 57105|
|Principal Investigator:||William C Spanos, MD||Sanford Health/Sanford Clinic ENT|