Radiation Induced Fibrosis to the Head and Neck
Conditions
Keywords
fibrosis, radiation, neck, cancer, Sodermix
Brief 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.
Interventions
DRUGTopical 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.
DRUGPlacebo
Placebo or cetaphil cream will be applied twice daily, of half dollar size for 12 weeks to fibrosed area.
Sponsors
Sanford Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* must have evidence of neck fibrosis * previous radiation treatment to the neck for cancer * age greater than or equal to 18 years * life expectancy of greater than 12 weeks * ability to understand the purpose of the study and the willingness to sign a written informed consent document.
Exclusion criteria
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to SOD or Cetaphil cram. * any psychological, familial, sociological or geographical conditions that do not permit medical follow-up and compliance with the study protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in Neck Fibrosis | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Determine the Quality of Life Impact From Radiation Related Fibrosis in Head and Neck Cancer Patients | 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 | 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 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 |
| Cervical Spine Range of Motion | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Topical Sodermix Dismutase Patients with measurable radiation induced fibrosis of the neck. Patients will be randomized to Topical Sodermix Dismutase in the form of Sodermix(SOD)
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. | 38 |
| Placebo Group Cetaphil cream
Placebo: Placebo or cetaphil cream will be applied twice daily, of half dollar size for 12 weeks to fibrosed area. | 36 |
| Total | 74 |
Baseline characteristics
| Characteristic | Placebo Group | Topical Sodermix Dismutase | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 10 Participants | 10 Participants | 20 Participants |
| Age, Categorical Between 18 and 65 years | 26 Participants | 28 Participants | 54 Participants |
| Age, Continuous | 61.64 years STANDARD_DEVIATION 9.73 | 60.98 years STANDARD_DEVIATION 9.64 | 61.3 years STANDARD_DEVIATION 9.62 |
| Region of Enrollment United States | 36 participants | 38 participants | 74 participants |
| Sex: Female, Male Female | 7 Participants | 8 Participants | 15 Participants |
| Sex: Female, Male Male | 29 Participants | 30 Participants | 59 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 38 | 0 / 36 |
| serious Total, serious adverse events | 0 / 38 | 0 / 36 |
Outcome results
Primary
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
Population: All subjects randomized between August 2012 and May 2013.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Topical Sodermix Dismutase | Improvement in Neck Fibrosis | 13 participants |
| Placebo Group | Improvement in Neck Fibrosis | 13 participants |
Secondary
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
Population: Patients with pre-treatment and post-treatment measures.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical Sodermix Dismutase | Cervical Spine Range of Motion | -7.14 degrees | Standard Deviation 14.27 |
| Placebo Group | Cervical Spine Range of Motion | -9.77 degrees | Standard Deviation 20.63 |
Comparison: Looking at the difference in range of motion change over time. The null hypothesis is there was no difference between the two treatment groups.p-value: 0.5795% CI: [-6.65, 11.91]t-test, 2 sided
Secondary
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.
Population: All patients who had a pre-treatment and post-treatment pain score.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical Sodermix Dismutase | Determine the Pain From Radiation Related Fibrosis in Head and Neck Cancer Patients | 0.31 score on a scale | Standard Deviation 1.01 |
| Placebo Group | Determine the Pain From Radiation Related Fibrosis in Head and Neck Cancer Patients | 0.13 score on a scale | Standard Deviation 1.81 |
Comparison: Looking at the difference in pain change over time. The null hypothesis is there was no difference between the two treatment groups.p-value: 0.6595% CI: [-0.6, 0.95]t-test, 2 sided
Secondary
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
Population: The analysis population are those who filled out the Quality of Life questionnaire at baseline and 3 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical Sodermix Dismutase | Determine the Quality of Life Impact From Radiation Related Fibrosis in Head and Neck Cancer Patients | 2.30 score on a scale | Standard Deviation 6.6 |
| Placebo Group | Determine the Quality of Life Impact From Radiation Related Fibrosis in Head and Neck Cancer Patients | 0.44 score on a scale | Standard Deviation 9.17 |
p-value: 0.57Wilcoxon Rank-Sum