Study of Topical Superoxide Dismutase to Treat Radiation Induced Fibrosis (Sodermix)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Radiation Induced Fibrosis to the Head and Neck |
Drug: Topical Sodermix Dismutase in the form of Sodermix (SOD) Drug: Placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Topical Superoxide Dismutase For the Treatment of Radiation Induced Fibrosis in the Head and Neck Cancer Patient |
- Improvement in neck fibrosis [ Time Frame: 3 months ] [ Designated as safety issue: No ]Improvement in fibrosis as defined as a one point improvement on the fibrosis scale.
- Determine the quality of life impact from radiation related fibrosis in head and neck cancer patients [ Time Frame: 3 months ] [ Designated as safety issue: No ]Metrics are measured via analysis of pain and range of motion and Health Related Quality of Life questionnaire.
| Estimated Enrollment: | 80 |
| Study Start Date: | August 2012 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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)
|
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.
Other Names:
|
|
Placebo Comparator: Placebo group
Cetaphil cream
|
Drug: Placebo
Placebo or cetaphil cream will be applied twice daily, of half dollar size for 12 weeks to fibrosed area.
Other Name: Cetaphil cream
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts 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.
Contacts and Locations| United States, South Dakota | |
| Sanford Health | |
| Sioux Falls, South Dakota, United States, 57105 | |
| Principal Investigator: | William H Avery, DO | Sanford Health/Sanford Clinic ENT |
More Information
No publications provided
| Responsible Party: | Sanford Health |
| ClinicalTrials.gov Identifier: | NCT01771991 History of Changes |
| Other Study ID Numbers: | SOD 2012 |
| Study First Received: | January 11, 2013 |
| Last Updated: | January 16, 2013 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by Sanford Health:
|
fibrosis radiation neck cancer Sodermix |
Additional relevant MeSH terms:
|
Fibrosis Head and Neck Neoplasms Pathologic Processes Neoplasms by Site Neoplasms Superoxide Dismutase Emollients Free Radical Scavengers |
Antioxidants Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protective Agents Physiological Effects of Drugs Dermatologic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013