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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topical Sodermix Dismutase | Experimental | 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. |
|
| Placebo group | Placebo Comparator | Cetaphil cream |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topical Sodermix Dismutase in the form of Sodermix (SOD) | Drug | Topical Sodermix Dismutase in the form of Sodermix (SOD) will be applied twice daily, of half dollar application for 12 weeks to fibrosed area. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William C Spanos, MD | Sanford Health/Sanford Clinic ENT | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanford Health | Sioux Falls | South Dakota | 57105 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Placebo Group | Cetaphil cream Placebo: Placebo or cetaphil cream will be applied twice daily, of half dollar size for 12 weeks to fibrosed area. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All subjects randomized between August 2012 and May 2013. | Posted | Number | participants | 3 months |
|
3 months
During each study visit and telephone interview, scheduled weekly, subjects will be asked open-ended questions to elicit any medically related changes in their well-being.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Chad Spanos MD | Sanford Health | 605-328-8200 |
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| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| Placebo | Drug | Placebo or cetaphil cream will be applied twice daily, of half dollar size for 12 weeks to fibrosed area. |
|
|
| 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
Differences between baseline scores and 3 month score | 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. | 3 months |
| BG001 | Placebo Group | Cetaphil cream Placebo: Placebo or cetaphil cream will be applied twice daily, of half dollar size for 12 weeks to fibrosed area. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
Cetaphil cream Placebo: Placebo or cetaphil cream will be applied twice daily, of half dollar size for 12 weeks to fibrosed area. |
|
|
| 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) | The analysis population are those who filled out the Quality of Life questionnaire at baseline and 3 months. | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
|
|
|
| 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
Differences between baseline scores and 3 month score | All patients who had a pre-treatment and post-treatment pain score. | Posted | Mean | Standard Deviation | score on a scale | From baseline to 3 months. |
|
|
|
|
| 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. | Patients with pre-treatment and post-treatment measures. | Posted | Mean | Standard Deviation | degrees | 3 months |
|
|
|
|
| 0 |
| 38 |
| 0 |
| 38 |
| EG001 | Placebo Group | Cetaphil cream Placebo: Placebo or cetaphil cream will be applied twice daily, of half dollar size for 12 weeks to fibrosed area. | 0 | 36 | 0 | 36 |
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