RecruitingPHASE3INTERVENTIONAL

Combination Therapy: Hyperbaric Oxygen and PENTOCLO for Treatment of Osteoradionecrosis of the Mandible

This pilot study investigates a new way to treat osteoradionecrosis (ORN) of the jaw, a serious side effect that can occur after radiation therapy for head and neck cancers. ORN causes dead bone in the jaw and can be very painful, hard to treat, and greatly affect someone's quality of life. Current treatments often include hyperbaric oxygen therapy (HBOT), which involves breathing special oxygen, or a medication mix called PENTOCLO. This study will be the first to combine HBOT with a modified version of PENTOCLO to see if it works better than HBOT alone. The main goal is to understand how practical this combined approach is and to help plan a larger study in the future. Researchers will look at pain levels, side effects, and if surgery is needed.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Sunnybrook Health Sciences Centre

Enrolment target

Start

16 Jan 2025

Estimated completion

01 Dec 2027

Osteoradionecrosis Osteoradionecrosis of Jaw Osteoradionecrosis of the Mandible

What is this study about?

When people have radiation treatment for head and neck cancers, sometimes a serious problem called osteoradionecrosis (ORN) can develop in their jaw. This means some of the bone in the jaw can die and become exposed, either inside or outside the mouth. It can be very painful, difficult to treat, and can have a big impact on a person's daily life and overall wellbeing.

Currently, there are a couple of ways doctors try to help people with ORN. One is called hyperbaric oxygen therapy (HBOT), where patients go into a special chamber to breathe pure oxygen. This can often involve many sessions over several weeks. Another option is a treatment called PENTOCLO, which is a mix of different medicines taken over a long period, usually at least a year. These treatments are often used on their own, or with other supportive care.

This study is looking at whether combining HBOT with a modified version of PENTOCLO could be an even better treatment for ORN of the jaw. It's a 'pilot study', which means it's a smaller, early-stage study designed to help researchers understand if this combined approach is practical and how to best set up a larger, more definitive study in the future. The researchers will be carefully checking things like how much pain people experience, any side effects, and if they need surgery. The goal is to find more effective ways to help people living with this challenging condition.

Key takeaways

This study evaluates combining oxygen therapy with a medication mix for jaw bone problems.
The condition, osteoradionecrosis (ORN), can occur after radiation for head/neck cancer.
It's a pilot study to see if the combined treatment is practical for a bigger trial.
Researchers will track pain, side effects, and need for surgery over 12 months.
Participation requires frequent visits for treatment and monitoring.

Who may be eligible?

To be able to join this study, you would need to have received radiation therapy for head and neck cancer and then be diagnosed with ORN in your jaw. The ORN needs to be a certain size – larger than a small bone chip. You also must be able to safely have hyperbaric oxygen therapy, which a specialist doctor will check for you.

There are also some reasons why you might not be able to join. For example, if you've already had certain treatments for ORN, like previous HBOT or PENTOCLO, or if you're planning a major surgery. Some other health conditions, like severe liver or kidney disease, or certain heart problems, would also mean you couldn't take part. Pregnant or breastfeeding women, or those who can't safely take the study medications, would also not be eligible.

Finally, you need to be at least 18 years old and able to understand and agree to take part in the study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Have I been diagnosed with osteoradionecrosis (ORN) in my jaw after radiation for cancer?
Am I at least 18 years old?
Can I safely have hyperbaric oxygen therapy (HBOT)?
Have I NOT had previous treatments like PENTOCLO, HBOT, or surgery for ORN?
Do I have any severe health conditions (e.g., severe liver/kidney disease, certain heart problems) or contraindications to the medications?
Am I able to commit to 60 HBOT sessions and 12 months of follow-up?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be assigned by chance to one of two groups: either you'll receive the standard hyperbaric oxygen therapy (HBOT) or you'll receive HBOT plus the modified PENTOCLO medication mix. The HBOT usually involves up to 60 treatments in a special chamber.

If you're in the group receiving PENTOCLO, you will also take several different oral medications for at least a year. This will involve taking antibiotics first, followed by a combination of other pills. You'll have regular follow-up visits with the study team for 12 months. These visits will happen at around 4 weeks, 5 or 6 weeks, then at 3, 6, 9, and 12 months after you start treatment. During these visits, the team will check your pain levels, look at your jaw, ask about your quality of life, and monitor for any side effects.

Potential risks and benefits

Taking part in any study has potential benefits and risks. While this is a pilot study, it aims to explore a potentially more effective treatment for ORN, which could lead to better outcomes for patients in the future. However, there's no guarantee that you will personally benefit. You might experience side effects from the treatments, as all medications and therapies carry some risk. The study team will carefully monitor you for any problems. Remember, your participation is completely voluntary, and you can withdraw from the study at any time without affecting your medical care.

Locations (1)

Sunnybrook Health Sciences Centre
Verified postcode
Toronto, Canada· Recruiting

Common questions

What is osteoradionecrosis (ORN)?

ORN is a serious problem where bone in the jaw dies, often after radiation treatment for head or neck cancer. It can be painful and impact daily life.

What is hyperbaric oxygen therapy (HBOT)?

HBOT involves breathing pure oxygen in a special chamber, which can help promote healing in certain conditions.

What is PENTOCLO?

PENTOCLO is a mix of oral medications, including antibiotics, followed by other drugs, taken over a long period to help treat ORN.

What is a 'pilot study'?

A pilot study is a small, early-stage study that helps researchers figure out if a new treatment approach is practical and how to design a larger, more complete study later on.

How long would I need to be in the study?

You would be followed for 12 months from the start of your treatment, with regular check-ups during that time.

How to find out more

Ben Safa, MD

ben.safa@sunnybrook.ca 416-480-4864 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.