Phase 3 Head and Neck Cancer Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been diagnosed with a bone condition called osteonecrosis of the jaw (ORN) following completion of radiation therapy, where there is an exposed, damaged area of jaw bone larger than 20 mm²
• People who a Hyperbaric (high-pressure oxygen) specialist doctor has assessed as having no medical reasons preventing them from receiving hyperbaric oxygen therapy, and who are willing and able to attend 60 treatment sessions
• People aged 18 or older
• People who have had a heart tracing test (ECG) done within the 60 days before joining the trial
• Women of childbearing age who are either using an accepted form of contraception (such as hormonal contraceptives, an IUD, implants, or whose partner has had a vasectomy), or who have a negative pregnancy test at the start of the trial

Who may not be able to join:

• People who are unable to give informed consent to participate
• People who have already received previous treatment for ORN, including a specific drug combination (PENTOCLO), hyperbaric oxygen therapy, or surgery for this condition
• People who have a major surgical procedure planned (more extensive than a minor bone fragment removal)
• People with severe jaw tightening (trismus) that makes it impossible to take photos inside the mouth
• People who have medical reasons that prevent them from receiving hyperbaric oxygen therapy, including a collapsed lung, certain lung conditions, uncontrolled high blood pressure, uncontrolled epilepsy, or severe fear of confined spaces
• People who have medical reasons preventing them from taking the study drug combination (mPENTOCLO), including: difficulty swallowing tablets; pregnancy or breastfeeding; allergy to any of the study drugs; currently taking blood-thinning tablets; bleeding or clotting disorders; Vitamin K deficiency; active unresolved heart disease; or severe liver or kidney disease
• People whose recent ECG (within 60 days before joining) shows a heart rhythm abnormality known as QT prolongation, unless the cause has been identified and corrected before joining, confirmed by a repeat heart tracing
• People currently taking certain medications known to significantly affect heart rhythm (such as erythromycin, cisapride, astemizole, pimozide, or quinidine), unless a treating doctor determines it is safe to stop or switch those medications before the trial begins
• People taking certain other medications with a lower but possible risk of affecting heart rhythm (such as ondansetron or SSRIs) may be excluded if a heart tracing done within 24–48 hours of starting two of the study drugs shows a significant heart rhythm change (confirm with trial site)
• People with a history of a specific type of liver or jaundice problem linked to a particular antibiotic (amoxicillin-clavulanate)
• People with moderate to severe active liver disease, or active liver disease with significantly abnormal liver test results
• People with a history of the muscle condition myasthenia gravis
• People with a history of serious tendon problems not caused by injury, particularly where there has been significant swelling or a partial tendon tear
• People who have previously experienced nerve damage (peripheral neuropathy) caused by antibiotics
• People who currently smoke, have a high alcohol intake (averaging more than 2 standard drinks per day), have a serious infection (sepsis), are severely malnourished, or have a severe immune deficiency condition (such as HIV or certain autoimmune diseases)
• People with ongoing or returning cancer, or any active cancer diagnosis
• People with a documented Vitamin K deficiency
• People currently taking additional Vitamin E supplements
• People currently prescribed bone-affecting medications (such as risedronate, alendronate, zoledronic acid, denosumab, or similar drugs)
• People diagnosed with a specific eye condition called retinitis pigmentosa
• People diagnosed with clinically significant anaemia (low red blood cell levels)

Important: Always verify eligibility with the trial site directly before applying.