An interventional study of Topical Sodermix Dismutase in the form of Sodermix (SOD) and Placebo in Radiation Induced Fibrosis to the Head and Neck, sponsored by Sanford Health. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-05.
Sponsored by Sanford Health · Not applicable, Interventional, and Treatment
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.
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.
36 studies on the registry are indexed under Radiation Pneumonitis; 15 are open to participants now.
This study's enrollment of 74 is close to the median of 70 across 21 interventional studies indexed under Radiation Pneumonitis.
Browse Radiation Pneumonitis studies →Sanford Health is the lead sponsor of 39 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
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)
Cetaphil cream
Drug: Placebo
Topical Sodermix Dismutase in the form of Sodermix (SOD) will be applied twice daily, of half dollar application for 12 weeks to fibrosed area.
Also known as: Sodermix, SOD
Placebo or cetaphil cream will be applied twice daily, of half dollar size for 12 weeks to fibrosed area.
Also known as: Cetaphil cream
Improvement in Neck Fibrosis
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.
Time frame: 3 months
Determine the Quality of Life Impact From Radiation Related Fibrosis in Head and Neck Cancer Patients
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)
Time frame: 3 months
Determine the Pain From Radiation Related Fibrosis in Head and Neck Cancer Patients
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 1. - Very minor annoyance-occasional minor twinges 2. - Minor annoyance-occasional, does not interfere with activities 3. - Annoying enough to be distracting 4. - Can be ignored if you are really involved in your work, but still distracting, 5. - Can't be ignored for more than 30 minutes. Interrupts some activities. 6. - Can't be ignored for any length of time, but you can still go to work and participate in social activities. 7. - Make it difficult to concentrate, interferes with sleep, you can still function with effort, prevents doing daily activities 8. - Physical activity severely limited. You can read and converse with effort. Hard to do anything 9. - Unable to do anything, Can't bear the pain 10. - Bad as it could be, nothing else matters Differences between baseline scores and 3 month score
Time frame: From baseline to 3 months.
Cervical Spine Range of Motion
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.
Time frame: 3 months
| Milestone | Topical Sodermix Dismutase | Placebo Group |
|---|---|---|
| Started | 38 | 36 |
| Started treatment | 37 | 34 |
| Completed | 30 | 30 |
| Not completed | 8 | 6 |
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.
| participants | Topical Sodermix Dismutase | Placebo Group |
|---|---|---|
| Improvement in Neck Fibrosis | 13 | 13 |
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)
| score on a scale | Topical Sodermix Dismutase | Placebo Group |
|---|---|---|
| Determine the Quality of Life Impact From Radiation Related Fibrosis in Head and Neck Cancer Patients | 2.30 ± 6.60 | 0.44 ± 9.17 |
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 1. - Very minor annoyance-occasional minor twinges 2. - Minor annoyance-occasional, does not interfere with activities 3. - Annoying enough to be distracting 4. - Can be ignored if you are really involved in your work, but still distracting, 5. - Can't be ignored for more than 30 minutes. Interrupts some activities. 6. - Can't be ignored for any length of time, but you can still go to work and participate in social activities. 7. - Make it difficult to concentrate, interferes with sleep, you can still function with effort, prevents doing daily activities 8. - Physical activity severely limited. You can read and converse with effort. Hard to do anything 9. - Unable to do anything, Can't bear the pain 10. - Bad as it could be, nothing else matters Differences between baseline scores and 3 month score
| score on a scale | Topical Sodermix Dismutase | Placebo Group |
|---|---|---|
| Determine the Pain From Radiation Related Fibrosis in Head and Neck Cancer Patients | 0.31 ± 1.01 | 0.13 ± 1.81 |
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.
| degrees | Topical Sodermix Dismutase | Placebo Group |
|---|---|---|
| Cervical Spine Range of Motion | -7.14 ± 14.27 | -9.77 ± 20.63 |
Collected over 3 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Topical Sodermix Dismutase | — | 0/38 (0%) | 0/38 (0%) |
| Placebo Group | — | 0/36 (0%) | 0/36 (0%) |
| Age, Categorical(Participants) | Topical Sodermix Dismutase | Placebo Group | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 28 | 26 | 54 |
| >=65 years | 10 | 10 | 20 |
| Age, Continuous(years) | Topical Sodermix Dismutase | Placebo Group | Total |
|---|---|---|---|
| Mean | 60.98 ± 9.64 | 61.64 ± 9.73 | 61.3 ± 9.62 |
| Sex: Female, Male(Participants) | Topical Sodermix Dismutase | Placebo Group | Total |
|---|---|---|---|
| Female | 8 | 7 | 15 |
| Male | 30 | 29 | 59 |
| Region of Enrollment(participants) | Topical Sodermix Dismutase | Placebo Group | Total |
|---|---|---|---|
| United States | 38 | 36 | 74 |
This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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