Radiation Induced Fibrosis to the Head and NeckSodermixNCT01771991
Study of Topical Superoxide Dismutase to Treat Radiation Induced Fibrosis
A study testing Topical Sodermix Dismutase in the form of Sodermix (SOD) in people with Radiation Induced Fibrosis to the Head and Neck, run by Sanford Health at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiation Induced Fibrosis to the Head and Neck
- What is being tested?
- Topical Sodermix Dismutase in the form of Sodermix (SOD)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Jun 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Topical Sodermix Dismutase in the form of Sodermix (SOD), Placebo
- Keywords
- fibrosis, radiation, neck, cancer, Sodermix
- Medical subject headings
- Fibrosis, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical Sodermix Dismutase in the form of Sodermix (SOD)Drug
Also called 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.
PlaceboDrug
Also called Cetaphil cream
Placebo or cetaphil cream will be applied twice daily, of half dollar size for 12 weeks to fibrosed area.
| Study group | Role | What they receive |
|---|---|---|
| Topical Sodermix Dismutase | Experimental | 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. Receives: Drug: Topical Sodermix Dismutase in the form of Sodermix (SOD) |
| Placebo group | Placebo comparator | Cetaphil cream Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (3)
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)
Measured: 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
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2013 (estimated)
- Study startAug 2012
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Radiation Induced Fibrosis to the Head and NeckStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanford Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William C Spanos, MD, Principal investigator, Sanford Health/Sanford Clinic ENT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01771991
- Sponsor's protocol ID
- SOD 2012
- Acronym
- Sodermix
- Status last verified
- Nov 2017
- First submitted
- 11 Jan 2013
- Last updated
- 5 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Superoxide Dismutase For the Treatment of Radiation Induced Fibrosis in the Head and Neck Cancer Patient
- ClinicalTrials.gov ID
- NCT01771991
- Acronym / sponsor ID
- Sodermix / SOD 2012
- Keywords
- fibrosis, radiation, neck, cancer, Sodermix
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Sanford HealthUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 21 Jan 2013 (estimated)
- Results
- Posted 24 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Topical Sodermix Dismutase | Experimental | Drug: Topical Sodermix Dismutase in the form of Sodermix (SOD)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. |
| Placebo group | Placebo comparator | Drug: PlaceboCetaphil cream |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topical Sodermix Dismutase in the form of Sodermix (SOD)Also: Sodermix, SODTopical Sodermix Dismutase in the form of Sodermix (SOD) will be applied twice daily, of half dollar application for 12 weeks to fibrosed area. | Drug | Topical Sodermix Dismutase |
| PlaceboAlso: Cetaphil creamPlacebo or cetaphil cream will be applied twice daily, of half dollar size for 12 weeks to fibrosed area. | Drug | Placebo group |
Primary outcome
Improvement in Neck Fibrosis
Time frame: 3 months
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 secondary outcomes
Determine the Quality of Life Impact From Radiation Related Fibrosis in Head and Neck Cancer Patients
Time frame: 3 months
Determine the Pain From Radiation Related Fibrosis in Head and Neck Cancer Patients
Time frame: From baseline to 3 months.
Cervical Spine Range of Motion
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William C Spanos, MD principal investigator
Sanford Health/Sanford Clinic ENT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topical Sodermix Dismutase in the form of Sodermix (SOD) in people with Radiation Induced Fibrosis to the Head and Neck, run by Sanford Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in Neck Fibrosis (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2019.