Study of Topical Superoxide Dismutase to Treat Radiation Induced Fibrosis (Sodermix)
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|ClinicalTrials.gov Identifier: NCT01771991|
Recruitment Status : Completed
First Posted : January 21, 2013
Results First Posted : April 24, 2015
Last Update Posted : February 27, 2017
|Condition or disease||Intervention/treatment||Phase|
|Radiation Induced Fibrosis to the Head and Neck||Drug: Topical Sodermix Dismutase in the form of Sodermix (SOD) Drug: Placebo||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||74 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Topical Superoxide Dismutase For the Treatment of Radiation Induced Fibrosis in the Head and Neck Cancer Patient|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||June 2013|
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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01771991
|United States, South Dakota|
|Sioux Falls, South Dakota, United States, 57105|
|Principal Investigator:||William C Spanos, MD||Sanford Health/Sanford Clinic ENT|