AuthorisedTherapeutic exploratory (Phase II)Interventional

Quality of life and neurocognitive functioning in diffuse low-grade glioma patients treated with Temozolomide: feasibility study - TEMOIN

This study, called TEMOIN, is looking into how a specific medication, Temozolomide, might impact the quality of life and brain function of people living with certain slow-growing brain tumours, known as 'diffuse low-grade gliomas'. This is an early-stage study (Phase II) to check if it's possible and practical to run a larger study later on. Researchers want to see if enough people are willing to take part and if they can complete all the necessary check-ups over 12 months. They will ask participants to answer questions about their well-being and test their memory and thinking skills to understand the effects of the treatment. The study aims to make sure future research can be designed effectively.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Institut Regional Du Cancer De Montpellier

Enrolment target

Start

19 Sep 2024

Diffuse low-grade gliomas

What is this study about?

This study is called TEMOIN, and it's looking at a type of slow-growing brain tumour known as 'diffuse low-grade glioma'. These tumours grow slowly, but they can still affect a person's life over time. The study is specifically interested in how a medication called Temozolomide might affect two important areas for people with these tumours: their quality of life (how well they feel and live their daily lives) and their neurocognitive functioning (how well their brain works, including things like memory, thinking, and concentration).

This is an early-stage study, often called a 'Phase II' or 'therapeutic exploratory' study. This means it's not primarily about finding out if the treatment definitely works, but rather about gathering information to see if a much bigger study would be practical and successful in the future. The researchers want to know if enough people with this type of tumour would be willing to join the study and, once they've joined, if they'd be able to complete all the regular check-ups and assessments over a year. They're hoping that at least 80% of people who are offered the chance to join will say yes, and that 80% of those who join will complete all parts of the study.

The main goal is to figure out if it's 'feasible' – meaning if it's possible to run this kind of research. To do this, they will ask participants to fill out questionnaires about their general health, well-being, and any difficulties they might be having with memory or thinking. They will also do some tests to check brain functions like memory and how quickly people can process information. This information will help them understand the real-world impact of the treatment on patients and make plans for more extensive studies in the future, if this initial study shows it's a good idea.

Key takeaways

This study focuses on people with diffuse low-grade gliomas.
It investigates the impact of Temozolomide on quality of life and brain function.
It's an early-stage study to check if a larger study is possible.
Participants will complete questionnaires and brain function tests over 12 months.
It's open to adults aged 18 and over, both men and women.

Who may be eligible?

To be part of this study, you need to be an adult, aged 18 years or older. There is no upper age limit, meaning older adults can also take part. The study is open to both men and women.

More detailed eligibility rules would likely be discussed with your doctor or the study team. These rules are put in place to make sure the study gathers clear results and that it's safe for everyone involved. For example, they might look at your specific diagnosis, other health conditions you have, and any other treatments you're currently receiving.

It's very important to talk to your doctor if you're interested in joining. They can help you understand if this study is suitable for you based on your personal health situation and medical history. Never stop or change any current treatments without speaking to your doctor first.

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.

Are you 18 years old or older?
Do you have a diagnosis of diffuse low-grade glioma?
Are you able to attend appointments over a 12-month period?
Are you comfortable filling out questionnaires and doing thinking/memory tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be asked to attend regular appointments for one year (12 months). At the beginning of the study (called 'baseline'), after 6 months, and again at 12 months, you would have evaluations. These evaluations would involve answering several questionnaires about your general well-being, your quality of life, and any challenges you might be experiencing with tiredness or brain function. You would also take part in tests designed to check your memory, thinking speed, and other brain abilities. The study aims to understand how well people can complete these evaluations and how they feel during the study, rather than focusing on the treatment itself, which is Temozolomide.

Potential risks and benefits

Participating in any study has potential benefits and risks. A potential benefit of taking part in this study is that you would receive regular monitoring of your quality of life and brain function, which could provide valuable insights into your health. You would also be contributing to medical research, which could help future patients with diffuse low-grade gliomas. However, Temozolomide, like any medication, has potential side effects, and some people might find the regular assessments time-consuming or tiring. You would be fully informed of all known side effects before joining. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
France

Common questions

What is 'diffuse low-grade glioma'?

It's a type of slow-growing brain tumour. 'Diffuse' means it's spread out, and 'low-grade' means it's less aggressive than other types.

What is Temozolomide?

Temozolomide is a medication often used to treat certain brain tumours. It's a type of chemotherapy.

What does 'quality of life' mean in this study?

It refers to how well you feel and live your daily life, including your physical, emotional, and social well-being.

What does 'neurocognitive functioning' mean?

It's about how well your brain works, specifically your memory, attention, problem-solving, and thinking speed.

Why is this called a 'feasibility study'?

It's an early-stage study to see if it's practical to conduct a larger, more in-depth study later on. They want to check if enough people are willing to join and complete the tasks required.