Management of Mandibular ORN: PENTO as Medical Treatment (NCT02368457) | Clinical Trial Compass
CompletedPhase 4
Management of Mandibular ORN: PENTO as Medical Treatment
Spain24 participantsStarted 2016-02
Plain-language summary
Mandibular osteoradionecrosis, despite its low incidence, remains being the most problematic and irreversible complication after head and neck radiotherapy with no medical treatment to limit or reduce symptoms.
Different clinical trials have shown a significant scientific evidence that the treatment with pentoxifylline + tocopherol achieves a certain effectiveness in the treatment of the tissue fibrosis. This study proposes to use this drugs to determine if there is healing of mandibular osteoradionecrosis and/or a symptomatic improvement as well.
Who can participate
Age range
18 Years – 90 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:
* Over 18 years and under 90 years old.
* Patients who have received radiotherapy after being diagnosed with head and neck cancer and currently are diagnosticated of mandibular osteoradionecrosis (any clinical stage)
* Follow-up for at least a year after the radiation treatment is completed.
* Absence of tumor at the time of recruitment.
* Patients with the capacity to give informed consent
Exclusion Criteria:
* Allergy or hypersensitivity to Pentoxifylline or others xanthines, or to Tocopherol (vitamin E).
* Patients taking oral anticoagulants (acenocoumarol, warfarin).
* Known hemorrhagic/coagulation disorder.
* Vitamin K deficiency due to any cause.
* Use of estrogens oral contraceptives.
* Serious bleeding or extensive retinal hemorrhage.
* Ischaemic heart diseases, including recent Myocardial Infarction.
* Serious cardiac arrhythmia.
* Severe LIVER DISEASE.
* Severe renal failure (creatinine clearance \<30 mL/min).
* Hypotension.
* Female patients who are pregnant or lactating
* Any other situation or condition that, in the opinion of the INVESTIGATOR, may interfere with optimal PARTICIPATION in the study.
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
1
Bone and/or Tissue Healing as Measured With the Classification of ORN Stages, Area of Bone Exposed (mm2) and Radiological Findings (OPG).
Timeframe: From baseline to 1, 3, 6, and 9 months of starting treatment