Study of Topical Superoxide Dismutase to Treat Radiation Induced Fibrosis (Sodermix)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanford Health
ClinicalTrials.gov Identifier:
NCT01771991
First received: January 11, 2013
Last updated: July 26, 2013
Last verified: July 2013
  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

Resource links provided by NLM:


Further study details as provided by Sanford Health:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 78
Study Start Date: August 2012
Primary Completion Date: July 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:
  • Sodermix
  • SOD
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
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01771991

Locations
United States, South Dakota
Sanford Health
Sioux Falls, South Dakota, United States, 57105
Sponsors and Collaborators
Sanford Health
Investigators
Principal Investigator: William C Spanos, MD 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: July 26, 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 April 17, 2014