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Study on Quality of Life and Brain Function in Patients with Diffuse Low-Grade Gliomas Treated with Temozolomide

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on patients with diffuse low-grade gliomas, a type of brain tumor. The study is investigating the effects of a medication called Temozolomide, which is used as a first-line treatment after surgery for these tumors. The main goal of the study is to assess the feasibility of conducting comprehensive assessments of patients' quality of life and cognitive functions over time.

Participants in the study will receive Temozolomide and will be monitored at the start, after six months, and after twelve months. These assessments will help researchers understand how the treatment affects patients' mental and emotional well-being, as well as their overall quality of life. The information gathered will be used to develop future studies that may involve multiple research centers.

The study will collect data on various aspects of patients' health, including their ability to think and remember, their emotional state, and their physical health. This information will help researchers form hypotheses for future research aimed at improving treatment and care for patients with diffuse low-grade gliomas. The study is designed to ensure that patients can participate and complete the necessary evaluations throughout the study period.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Introduction to the study

    Upon joining the study, the patient will receive an overview of the trial's purpose, which is to assess the quality of life and cognitive function in patients with diffuse low-grade gliomas treated with temozolomide.

    The patient will be informed about the study's duration, which includes assessments at the start, 6 months, and 12 months.

  2. Step 2

    Baseline assessment

    The patient will undergo a comprehensive evaluation of neurocognitive and psychological health, as well as quality of life. This will serve as the baseline for future comparisons.

    Various tests and questionnaires will be administered to gather data on cognitive abilities, emotional well-being, and overall life quality.

  3. Step 3

    Medication administration

    The patient will begin treatment with temozolomide, an oral medication. The dosage and frequency will be determined by the healthcare provider based on individual needs.

    The treatment will continue as the first line of therapy following surgery, with no prior cancer treatments except for surgery.

  4. Step 4

    6-month follow-up

    At the 6-month mark, the patient will return for a follow-up assessment. This will include the same tests and questionnaires as the baseline to monitor changes in cognitive function and quality of life.

    The results will help evaluate the impact of temozolomide on the patient's condition.

  5. Step 5

    12-month follow-up

    The final assessment will occur at 12 months, repeating the evaluations conducted at baseline and 6 months.

    This will provide a comprehensive view of the patient's progress and the effectiveness of the treatment over the study period.

  6. Step 6

    Data analysis and conclusion

    The data collected throughout the study will be analyzed to determine the feasibility of the treatment and its effects on quality of life and cognitive function.

    The findings will contribute to future research and potential improvements in treatment strategies for diffuse low-grade gliomas.

Who can join the trial?

13 criteria

  • Adult patient aged 18 or older, with no upper age limit.
  • Women who can have children must have a negative pregnancy test.
  • Must sign an informed consent form before any study procedures begin.
  • Patient must be fluent in French.
  • Patient must be part of the French social security system.
  • Must have a confirmed diagnosis of **Diffuse low-grade gliomas (DLGG)**, which is a type of brain tumor.
  • Patient must be receiving **TMZ** (a type of chemotherapy) as the first treatment after surgery, regardless of the time between surgery and starting TMZ.
  • No previous cancer treatments for the DLGG, except for surgery.
  • **Performance Status score** must be 2 or less, which is a measure of the patient's ability to perform daily activities.
  • **Absolute neutrophil count (ANC)** must be at least 1500 cells per microliter, and **platelet count** must be at least 100,000 cells per microliter. These are measures of certain blood cells.
  • **Total serum bilirubin concentration** must be no more than 1.5 times the normal upper limit. Bilirubin is a substance in the blood that can indicate liver function.
  • Levels of liver enzymes **aspartate aminotransferase (AST)**, **alanine aminotransferase (ALT)**, and **alkaline phosphatase** must be no more than 2.5 times the normal upper limit. These enzymes help assess liver health.
  • **Serum creatine concentration** must be no more than 1.5 times the normal upper limit. Creatine is a waste product in the blood that can indicate kidney function.

Who cannot join the trial?

4 criteria

  • Patients who are not diagnosed with Diffuse low-grade gliomas cannot participate. This is a type of brain tumor that grows slowly.
  • Patients who are not within the specified age range cannot participate. The study is for certain age groups only.
  • Patients who are not able to comply with the study requirements, such as attending assessments at baseline, 6 months, and 12 months, cannot participate.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.
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Investigated drugs

Temozolomide: This medication is used in the treatment of certain types of brain tumors, such as diffuse low-grade gliomas. It works by slowing or stopping the growth of cancer cells. In this study, Temozolomide is being evaluated to see how it affects the quality of life and neurocognitive functioning of patients after surgery.

What is already known about the treatment

Temozolomide – Temozolomide is administered orally in capsule form and is primarily used in the treatment of certain brain tumors, such as diffuse low-grade gliomas. It is currently well-documented in medical literature as a standard chemotherapy agent for these conditions. The main therapeutic indication for Temozolomide is to treat brain tumors by slowing or stopping the growth of cancer cells. At the molecular level, it works by damaging the DNA of cancer cells, which prevents them from dividing and growing. Temozolomide is classified as an alkylating agent, a type of chemotherapy drug that interferes with the DNA replication process in cancer cells.

Investigated diseases

Diffuse Low-Grade Gliomas – These are slow-growing brain tumors that originate from glial cells, which support and protect nerve cells in the brain. They are typically found in young adults and can cause symptoms such as seizures, headaches, and neurological deficits depending on their location in the brain. Over time, these tumors may infiltrate surrounding brain tissue, making them challenging to remove completely through surgery. Although they grow slowly, they can eventually transform into more aggressive forms of brain cancer. The progression of symptoms can vary widely among individuals, with some experiencing gradual changes and others facing more rapid developments. Regular monitoring through imaging and clinical assessments is essential to track their growth and impact on brain function.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-516918-37-00Protocol codeICM-URC 2016/32Estimated enrolment24 patientsSponsorInstitut Regional Du Cancer De Montpellier

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