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

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ClinicalTrials.gov Identifier: NCT01771991
Recruitment Status : Completed
First Posted : January 21, 2013
Results First Posted : April 24, 2015
Last Update Posted : April 5, 2019
Sponsor:
Information provided by (Responsible Party):
Sanford Health

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Radiation Induced Fibrosis to the Head and Neck
Interventions Drug: Topical Sodermix Dismutase in the form of Sodermix (SOD)
Drug: Placebo
Enrollment 74
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Topical Sodermix Dismutase Placebo Group
Hide Arm/Group Description

Patients with measurable radiation induced fibrosis of the neck. Patients will be randomized to Topical Sodermix Dismutase in the form of Sodermix(SOD)

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.

Cetaphil cream

Placebo: Placebo or cetaphil cream will be applied twice daily, of half dollar size for 12 weeks to fibrosed area.

Period Title: Overall Study
Started 38 36
Started Treatment 37 34
Completed 30 30
Not Completed 8 6
Arm/Group Title Topical Sodermix Dismutase Placebo Group Total
Hide Arm/Group Description

Patients with measurable radiation induced fibrosis of the neck. Patients will be randomized to Topical Sodermix Dismutase in the form of Sodermix(SOD)

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.

Cetaphil cream

Placebo: Placebo or cetaphil cream will be applied twice daily, of half dollar size for 12 weeks to fibrosed area.

Total of all reporting groups
Overall Number of Baseline Participants 38 36 74
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 36 participants 74 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
28
  73.7%
26
  72.2%
54
  73.0%
>=65 years
10
  26.3%
10
  27.8%
20
  27.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 38 participants 36 participants 74 participants
60.98  (9.64) 61.64  (9.73) 61.3  (9.62)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 36 participants 74 participants
Female
8
  21.1%
7
  19.4%
15
  20.3%
Male
30
  78.9%
29
  80.6%
59
  79.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 38 participants 36 participants 74 participants
38 36 74
1.Primary Outcome
Title Improvement in Neck Fibrosis
Hide Description 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.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects randomized between August 2012 and May 2013.
Arm/Group Title Topical Sodermix Dismutase Placebo Group
Hide Arm/Group Description:

Patients with measurable radiation induced fibrosis of the neck. Patients will be randomized to Topical Sodermix Dismutase in the form of Sodermix(SOD)

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.

Cetaphil cream

Placebo: Placebo or cetaphil cream will be applied twice daily, of half dollar size for 12 weeks to fibrosed area.

Overall Number of Participants Analyzed 38 36
Measure Type: Number
Unit of Measure: participants
13 13
2.Secondary Outcome
Title Determine the Quality of Life Impact From Radiation Related Fibrosis in Head and Neck Cancer Patients
Hide Description

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)

Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population are those who filled out the Quality of Life questionnaire at baseline and 3 months.
Arm/Group Title Topical Sodermix Dismutase Placebo Group
Hide Arm/Group 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.

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.

Cetaphil cream

Placebo: Placebo or cetaphil cream will be applied twice daily, of half dollar size for 12 weeks to fibrosed area.

Overall Number of Participants Analyzed 22 20
Mean (Standard Deviation)
Unit of Measure: score on a scale
2.30  (6.60) 0.44  (9.17)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Topical Sodermix Dismutase, Placebo Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.57
Comments [Not Specified]
Method Wilcoxon Rank-Sum
Comments [Not Specified]
Method of Estimation Estimation Parameter sum of scores
Estimated Value 453
Parameter Dispersion
Type: Standard Deviation
Value: 39.6
Estimation Comments Standard Deviation under the Null hypothesis for each group.
3.Secondary Outcome
Title Determine the Pain From Radiation Related Fibrosis in Head and Neck Cancer Patients
Hide Description

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

  1. - Very minor annoyance-occasional minor twinges
  2. - Minor annoyance-occasional, does not interfere with activities
  3. - Annoying enough to be distracting
  4. - Can be ignored if you are really involved in your work, but still distracting,
  5. - Can’t be ignored for more than 30 minutes. Interrupts some activities.
  6. - Can’t be ignored for any length of time, but you can still go to work and participate in social activities.
  7. - Make it difficult to concentrate, interferes with sleep, you can still function with effort, prevents doing daily activities
  8. - Physical activity severely limited. You can read and converse with effort. Hard to do anything
  9. - Unable to do anything, Can’t bear the pain
  10. - Bad as it could be, nothing else matters

Differences between baseline scores and 3 month score

Time Frame From baseline to 3 months.
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who had a pre-treatment and post-treatment pain score.
Arm/Group Title Topical Sodermix Dismutase Placebo Group
Hide Arm/Group 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.

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.

Cetaphil cream

Placebo: Placebo or cetaphil cream will be applied twice daily, of half dollar size for 12 weeks to fibrosed area.

Overall Number of Participants Analyzed 26 30
Mean (Standard Deviation)
Unit of Measure: score on a scale
0.31  (1.01) 0.13  (1.81)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Topical Sodermix Dismutase, Placebo Group
Comments Looking at the difference in pain change over time. The null hypothesis is there was no difference between the two treatment groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.65
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.17
Confidence Interval (2-Sided) 95%
-0.60 to 0.95
Parameter Dispersion
Type: Standard Deviation
Value: 1.50
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Cervical Spine Range of Motion
Hide Description

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.

Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with pre-treatment and post-treatment measures.
Arm/Group Title Topical Sodermix Dismutase Placebo Group
Hide Arm/Group 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.

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.

Cetaphil cream

Placebo: Placebo or cetaphil cream will be applied twice daily, of half dollar size for 12 weeks to fibrosed area.

Overall Number of Participants Analyzed 29 30
Mean (Standard Deviation)
Unit of Measure: degrees
-7.14  (14.27) -9.77  (20.63)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Topical Sodermix Dismutase, Placebo Group
Comments Looking at the difference in range of motion change over time. The null hypothesis is there was no difference between the two treatment groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.57
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.63
Confidence Interval (2-Sided) 95%
-6.65 to 11.91
Parameter Dispersion
Type: Standard Deviation
Value: 17.79
Estimation Comments [Not Specified]
Time Frame 3 months
Adverse Event Reporting Description During each study visit and telephone interview, scheduled weekly, subjects will be asked open-ended questions to elicit any medically related changes in their well-being.
 
Arm/Group Title Topical Sodermix Dismutase Placebo Group
Hide Arm/Group Description

Patients with measurable radiation induced fibrosis of the neck. Patients will be randomized to Topical Sodermix Dismutase in the form of Sodermix(SOD)

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.

Cetaphil cream

Placebo: Placebo or cetaphil cream will be applied twice daily, of half dollar size for 12 weeks to fibrosed area.

All-Cause Mortality
Topical Sodermix Dismutase Placebo Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Topical Sodermix Dismutase Placebo Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/38 (0.00%)   0/36 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Topical Sodermix Dismutase Placebo Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/38 (0.00%)   0/36 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Chad Spanos MD
Organization: Sanford Health
Phone: 605-328-8200
Layout table for additonal information
Responsible Party: Sanford Health
ClinicalTrials.gov Identifier: NCT01771991     History of Changes
Other Study ID Numbers: SOD 2012
First Submitted: January 11, 2013
First Posted: January 21, 2013
Results First Submitted: April 9, 2015
Results First Posted: April 24, 2015
Last Update Posted: April 5, 2019