CompletedNot Applicable

Study of Topical Superoxide Dismutase to Treat Radiation Induced Fibrosis

United States74 participantsStarted 2012-08

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Improvement in Neck Fibrosis

Timeframe: 3 months

Trial details

NCT IDNCT01771991

SponsorSanford Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-06

Results submitted2015-04-09

View on ClinicalTrials.gov More Radiation Induced Fibrosis to the Head and Neck trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.