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 : April 5, 2019
|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 Health Related Quality of Life questionnaire.
Functional Assessment of Cancer Therapy for Head and Neck Cancer (FACT H&N) questionnaire was used to evaluate the quality of life in patient receiving treatment of head and neck cancer. Sub-categories of Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, Functional Well-Being, and Head & Neck Additional Concerns are included. Each category used a 5-point Likert scale ranged from 0 to 4 with 0= Not at all (no affect on daily activities) to 4=Very much (significant affect on daily activities).
Sub-categories were not analyzed individually. All were summed together for total score. Analysis was done comparing baseline scores and end of treatment scores.
Maximum scale total = 156 (answer of 4 to all items) Minimum scale total = 0 (answer of 0 to all items)
- Determine the Pain From Radiation Related Fibrosis in Head and Neck Cancer Patients [ Time Frame: From baseline to 3 months. ]
Subjects use the numeric verbal pain rating scale (0-10 scale specified for neck region with "0" being no pain and "10" extreme pain).
0 - Pain free
- - Very minor annoyance-occasional minor twinges
- - Minor annoyance-occasional, does not interfere with activities
- - Annoying enough to be distracting
- - Can be ignored if you are really involved in your work, but still distracting,
- - Can't be ignored for more than 30 minutes. Interrupts some activities.
- - Can't be ignored for any length of time, but you can still go to work and participate in social activities.
- - Make it difficult to concentrate, interferes with sleep, you can still function with effort, prevents doing daily activities
- - Physical activity severely limited. You can read and converse with effort. Hard to do anything
- - Unable to do anything, Can't bear the pain
- - Bad as it could be, nothing else matters
Differences between baseline scores and 3 month score
- Cervical Spine Range of Motion [ Time Frame: 3 months ]
Determine the effect of the treatment on Range of Motion over time. Cervical spine rotation was measured by a physical therapist using a goniometer.
A goniometer is an instrument that either measures an angle or allows an object to be rotated to a precise angular position. Results are documented in degrees.
Baseline measurements were compared with post-treatment measurements. A larger post-treatment measure when compared to the baseline measurement would indicate an increase of the cervical spine range of motion.
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|