Investigating Mechanistic Predictors of Interpatient Variability and Temozolomide (TMZ) Induced Haematological Toxicity for Glioma Patients
NCT Number: NCT06546631
Acronym: Improve TMZ
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Glioma
Sponsor: University College Cork
Collaborators: University Hospital of Limerick|University Hospital Waterford
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 55
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10
Completion Date: 2027-02

Summary:
A medication called temozolomide has been used for many years in the treatment of high-grade gliomas, which are tumours that originate in the brain. While this drug is the normal treatment for high-grade glioma, a number of patients develop a side-effect which results in low levels of some important blood cells, such as platelets or white blood cells. If this side-effect occurs, treatment with temozolomide may have to be stopped or paused, which may affect how well this treatment works.

At present, it is unknown why some patients develop this side effect and others do not. It is known that patients with a higher concentration of temozolomide in their blood are at an increased risk of developing this toxicity. There may be some factors associated with the movement of the drug in the body or the removal of the drug from the body which may affect the concentration of temozolomide in blood. There are many factors which may be involved, including genes, other medicines that are taken, how well kidneys and liver are working or even the microbiome (which is the bacteria in the gut).

This study is being done to find out what these factors could be. In the future, this may lead to medical care teams being able to predict which patients are at higher risk of side-effects, allowing them to implement measures to reduce the risk of this occurring.

Primary Outcome Measures: Determine potential predisposing factors for severe haematological toxicity from temozolamide, Analysis of pharmacogenes, On study registration|Determine potential predisposing factors for severe haematological toxicity from temozolamide, Microbiome analysis of stool bacterial composition, Baseline and study completion, an average of 9 months
Secondary Outcome Measures: Assess duration of haematological toxicity from temozolamide, Duration measured in time (days/weeks)., Up to 12 months|Assess severity of haematological toxicity from temozolamide, Severity measured by Common Terminology Criteria for Adverse Events (CTCAE) Grade (grades range from 1-5, with higher grades indicating higher severity)., Up to 12 months|Assess the impact of haematological toxicity on patients, Number of blood transfusions required as a result of the haematological toxicity, Up to 12 months|Assess the impact of haematological toxicity on patients, Number of platelet transfusions required as a result of the haematological toxicity, Up to 12 months|Assess the impact of toxicity on patients distress tool scores, The European Organisation for Research and Treatment of Cancer (EoRTC) Quality of Life questionnaires for cancer patients (C-30, scores range from 30-126). Higher scores indicate lower quality of life., On date of study registration|Assess the impact of toxicity on patients quality of life scores, The European Organisation for Research and Treatment of Cancer (EoRTC) Quality of Life questionnaires for cancer patients brain-specific module BN-20 (scores range from 20-80). Higher scores indicate lower quality of life., On date of study registration|Assess the impact of toxicity on patients distress tool scores, The National Comprehensive Cancer Network distress thermometer (scores range from 0-10). Higher scores indicate more extreme distress., On date of study registration|Overall survival, Overall survival, From date of study registration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months