Clinical trial · Interventional
Study of Topical Superoxide Dismutase to Treat Radiation Induced Fibrosis
Topical Superoxide Dismutase For the Treatment of Radiation Induced Fibrosis in the Head and Neck Cancer Patient
NCT01771991CI-TRIAL-00037980SodermixcompletedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Radiation Induced Fibrosis to the Head and Neck | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Drug | — | UNRESOLVED |
| Topical Sodermix Dismutase in the form of Sodermix (SOD) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Topical Sodermix Dismutase
- description
- 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.
- interventionNames
- Drug: Topical Sodermix Dismutase in the form of Sodermix (SOD)
- type
- PLACEBO_COMPARATOR
- label
- Placebo group
- description
- Cetaphil cream
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Improvement in Neck Fibrosis
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.