N/A
N=74
Study of Topical Superoxide Dismutase to Treat Radiation Induced Fibrosis
Radiation Induced Fibrosis to the Head and Neck
Bottom Line
View on ClinicalTrials.gov: NCT01771991 ↗Enrolled (actual)
74
Serious AEs
0.0%
Results posted
Apr 2015
Primary outcome: Primary: Improvement in Neck Fibrosis — 13; 13 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Topical Sodermix Dismutase in the form of Sodermix (SOD) (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sanford Health
- Primary completion
- Jun 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Improvement in Neck Fibrosis |
13; 13 | — |
| SECONDARY Determine the Quality of Life Impact From Radiation Related Fibrosis in Head and Neck Cancer Patients |
2.30; 0.44 | 0.57 |
| SECONDARY Determine the Pain From Radiation Related Fibrosis in Head and Neck Cancer Patients |
0.31; 0.13 | 0.65 |
| SECONDARY Cervical Spine Range of Motion |
-7.14; -9.77 | 0.57 |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01771991). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.