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Topical Superoxide Dismutase For the Treatment of Radiation Induced Fibrosis in the Head and Neck Cancer Patient


N/A
18 Years
N/A
Open (Enrolling by invite only)
Both
Radiation Induced Fibrosis to the Head and Neck

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Trial Information

Topical Superoxide Dismutase For the Treatment of Radiation Induced Fibrosis in the Head and Neck Cancer Patient


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Improvement in neck fibrosis

Outcome Description:

Improvement in fibrosis as defined as a one point improvement on the fibrosis scale.

Outcome Time Frame:

3 months

Safety Issue:

No

Principal Investigator

William H Avery, DO

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sanford Health/Sanford Clinic ENT

Authority:

United States: Food and Drug Administration

Study ID:

SOD 2012

NCT ID:

NCT01771991

Start Date:

August 2012

Completion Date:

Related Keywords:

  • Radiation Induced Fibrosis to the Head and Neck
  • fibrosis
  • radiation
  • neck
  • cancer
  • Sodermix
  • Fibrosis
  • Head and Neck Neoplasms

Name

Location

Sanford HealthSioux Falls, South Dakota  57104