The Effect of Hyperbaric Oxygen Treatment in Patients With Osteoradionecrosis. (NCT04934644) | Clinical Trial Compass
UnknownNot Applicable
The Effect of Hyperbaric Oxygen Treatment in Patients With Osteoradionecrosis.
Sweden120 participantsStarted 2019-03-19
Plain-language summary
Osteoradionecrosis (ORN) is a severe delayed radiation-induced injury that can occur in patients whom have been subjected to radiotherapy for head and neck cancer. Hyperbaric oxygen treatment (HBO) is one treatment option. In Sweden it is used in some locations in combination to standard treatment which includes for example antibiotics, pain medication and surgery. There is still not sufficient evidence that this treatment is effective in this group of patients.
The primary aim of this study will be to evaluate HBO as a treatment for osteoradionecrosis in terms of slowing the progression of the disease, or at the best, cure the disease.
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:
* Osteoradionecrosis in the head and neck area (Stage 1-2b according to the classification by Schwartz and Kagan)
* Previous radiation with or without chemotherapy of a histologically verified primary tumor in the head and neck area.
* Patient free of tumor.
* Autonomous patient.
* Age ≥18 years old.
* WHO performance status 0-3.
* Ability to understand Swedish speech and writing.
* Received oral and written information about the study and given consent to participate in writing.
Exclusion Criteria:
* Contraindications against HBO.
* Participation in other ongoing study on osteoradionecrosis.
* Pregnancy or planned pregnancy.
* Woman in fertile age without effective contraceptive method.
* Alcohol or drug abuse.
* WHO performance status 4.
* Suspicion of recurrent tumor.
* Mental health disorder or other condition which makes the patient unable to follow study protocol.
* Not able to give informed concent.
* Previous HBO.
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.