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

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

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.

Study Overview

• Status: Completed
• Conditions: Radiation Induced Fibrosis to the Head and Neck
• Intervention / Treatment: Drug: Topical Sodermix Dismutase in the form of Sodermix (SOD); Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57105
      • Sanford Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Topical Sodermix Dismutase; 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.	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 Names: Cetaphil cream

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in Neck Fibrosis	Number of participants with improvement in fibrosis as defined as a one point improvement on the fibrosis scale using the grading scale outlined in CTCAE 4.03, page 46.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine the Quality of Life Impact From Radiation Related Fibrosis in Head and Neck Cancer Patients	Metrics are measured via analysis of Health Related Quality of Life questionnaire. Functional Assessment of Cancer Therapy for Head and Neck Cancer (FACT H&N) questionnaire was used to evaluate the quality of life in patient receiving treatment of head and neck cancer. Sub-categories of Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, Functional Well-Being, and Head & Neck Additional Concerns are included. Each category used a 5-point Likert scale ranged from 0 to 4 with 0= Not at all (no affect on daily activities) to 4=Very much (significant affect on daily activities). Sub-categories were not analyzed individually. All were summed together for total score. Analysis was done comparing baseline scores and end of treatment scores. Maximum scale total = 156 (answer of 4 to all items) Minimum scale total = 0 (answer of 0 to all items)	3 months
Determine the Pain From Radiation Related Fibrosis in Head and Neck Cancer Patients	Subjects use the numeric verbal pain rating scale (0-10 scale specified for neck region with "0" being no pain and "10" extreme pain). 0 - Pain free; - Very minor annoyance-occasional minor twinges; - Minor annoyance-occasional, does not interfere with activities; - Annoying enough to be distracting; - Can be ignored if you are really involved in your work, but still distracting,; - Can't be ignored for more than 30 minutes. Interrupts some activities.; - Can't be ignored for any length of time, but you can still go to work and participate in social activities.; - Make it difficult to concentrate, interferes with sleep, you can still function with effort, prevents doing daily activities; - Physical activity severely limited. You can read and converse with effort. Hard to do anything; - Unable to do anything, Can't bear the pain; - Bad as it could be, nothing else matters Differences between baseline scores and 3 month score	From baseline to 3 months.
Cervical Spine Range of Motion	Determine the effect of the treatment on Range of Motion over time. Cervical spine rotation was measured by a physical therapist using a goniometer. A goniometer is an instrument that either measures an angle or allows an object to be rotated to a precise angular position. Results are documented in degrees. Baseline measurements were compared with post-treatment measurements. A larger post-treatment measure when compared to the baseline measurement would indicate an increase of the cervical spine range of motion.	3 months

Collaborators and Investigators

• Sponsor: Sanford Health
• Investigators: Principal Investigator: William C Spanos, MD, Sanford Health/Sanford Clinic ENT

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: January 11, 2013
• First Submitted That Met QC Criteria: January 16, 2013
• First Posted (Estimate): January 21, 2013

Study Record Updates

• Last Update Posted (Actual): April 5, 2019
• Last Update Submitted That Met QC Criteria: April 2, 2019
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: cancer; radiation; fibrosis; neck; Sodermix
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Wounds and Injuries; Lung Diseases, Interstitial; Lung Injury; Radiation Injuries; Fibrosis; Radiation Pneumonitis
• Other Study ID Numbers: SOD 2012

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No