RecruitingNAINTERVENTIONAL

Amplitude Modulated Radiofrequency Electromagnetic Field Treatment Combined With Radiochemotherapy and Maintenance Chemotherapy in Patients With Glioblastoma (Brain-RF)

This study focuses on glioblastoma, a serious type of brain tumour. Researchers are investigating a new treatment approach that combines the usual chemotherapy and radiation therapy with a special treatment called 'radiofrequency electromagnetic field treatment'. This special device, currently only available at one German hospital, uses radio waves. Previous research has hinted that this radiofrequency treatment might help people with glioblastoma and have few side effects, especially in patients receiving palliative care. However, there isn't much information yet on how well it works when given alongside the very first round of chemotherapy and radiation. The study aims to find out if this combined treatment is practical and safe, and will compare results with similar patients receiving standard care.

At a glance

Status

Recruiting

Phase

Sponsor

Charite University, Berlin, Germany

Enrolment target

Start

15 Nov 2023

Estimated completion

14 May 2029

Glioblastoma

What is this study about?

Imagine you have a serious medical condition like glioblastoma, which is a type of brain tumour. Doctors are always looking for better ways to treat it. This study is exploring a new combination approach that brings together what's considered the standard treatment – that's chemotherapy and radiation – with something called 'radiofrequency electromagnetic field treatment'. You might think of it as using special radio waves, like those your radio picks up, but in a very controlled medical way, to treat the tumour.

Specifically, a hospital in Germany is using a particular type of machine that delivers this radiofrequency treatment. While there's some early information suggesting this radiofrequency method might be helpful and have few side effects for glioblastoma, especially for those needing comfort care, we don't have much solid evidence yet for when it's used right at the start of treatment alongside chemotherapy and radiation. That's where this study comes in.

The main goal of this research is to see if this combined treatment approach is practical and safe for patients. They want to understand if it's something that can be easily given to patients without causing too many problems. The researchers plan to carefully compare the experiences of patients in this study with those of other patients who have a similar type of brain tumour but are getting more standard care. This will help them learn more about how this new combined treatment might work.

Key takeaways

Studies a new combination treatment for glioblastoma.
Combines standard chemotherapy/radiation with radiofrequency treatment.
Aims to check safety and practicality of the new combination.
For newly diagnosed glioblastoma patients aged 18-70.
Specific eligibility rules apply, including prior surgery and good health.
Participation is voluntary, you can leave any time.

Who may be eligible?

To be considered for this study, you would generally need to have a newly diagnosed glioblastoma that has been confirmed by medical tests. You should be between 18 and 70 years old and generally able to perform daily activities without too much difficulty. It's also important that you've had surgery to remove most, if not all, of your tumour, and that your body's main organs (blood, kidneys, liver) are working well enough.

There are also some specific situations that would mean you couldn't join the study. For example, if you've already had radiation treatment to your head, or if you've had certain types of chemotherapy or anti-cancer treatments in the last five years. People with other serious health problems or cancers that limit their life expectancy to less than five years would also not be able to participate.

Finally, if you have certain medical devices like a pacemaker or metal implants, or if you can't have an MRI scan (due to allergies or other reasons), this study might not be suitable because these things can interfere with the treatments or tests involved. Pregnant women or those who cannot use effective contraception would also not be eligible.

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.

Is your glioblastoma newly diagnosed and medically confirmed?
Are you between 18 and 70 years old?
Have you had surgery to remove your brain tumour?
Do you generally feel well enough to do your daily activities?
Do you have any medical devices like a pacemaker or metal implants?
Are you able to have MRI scans?

Answer every question to see your result.

What does participation involve?

If you join this study, you would receive the standard chemotherapy and radiation treatment for your glioblastoma, along with the special radiofrequency electromagnetic field treatment. The radiation part would involve daily sessions over about six weeks, combined with daily chemotherapy tablets (temozolomide). After this, you would continue taking the chemotherapy tablets for six cycles, usually one cycle per month. The radiofrequency treatment would also be given alongside these treatments. You would have regular check-ups, scans (like MRI), and blood tests to monitor your progress and ensure your safety. The exact number of visits and the full duration of your participation would be explained in detail by the study team, but it would involve consistent treatment and follow-up during and after your chemotherapy cycles.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study is that you might receive a treatment combination that could prove more effective than standard treatment alone, though this is not guaranteed. However, there are also risks, as the radiofrequency treatment is relatively new in this combined setting, and there could be unknown side effects on top of those from standard chemotherapy and radiation. You would undergo regular monitoring to spot any problems early, but side effects could include skin irritation at the treatment site or issues related to your existing medical condition. It's crucial to remember that your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without affecting your future medical care.

Locations (1)

Charité Universitätsmedizin Berlin
Verified postcode
Berlin, Germany· Recruiting

Common questions

What is glioblastoma?

Glioblastoma is a serious type of cancer that starts in the brain. It's known to be quite aggressive.

What is 'radiofrequency electromagnetic field treatment'?

This is a treatment that uses special radio waves, similar to those that carry radio signals, but in a very controlled way to treat the tumour.

Is this a new treatment?

The radiofrequency treatment itself has been looked at before, but using it alongside initial chemotherapy and radiation for glioblastoma is what's being studied here.

Will I still get my normal cancer treatment?

Yes, if you join this study, you would still receive the standard chemotherapy and radiation therapy that's typically given for glioblastoma.

Where is this study taking place?

This study is being run by Charité Universitätsmedizin Berlin, a hospital in Germany. The special machine needed for the treatment is currently only available there in Germany.

How to find out more

Pirus Ghadjar, Prof. Dr.

pirus.ghadjar@charite.de +49 30 450 527318 Official trial record

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