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Study on Methylphenidate for Reducing Fatigue in Childhood Brain Tumor Survivors

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 is focused on understanding the effects of the medication methylphenidate on cancer-related fatigue in individuals who were treated for a brain tumor during childhood or adolescence. Cancer-related fatigue is a common issue that can persist after treatment for a brain tumor, affecting daily life and overall well-being. The study aims to see if methylphenidate, a medication often used to treat attention deficit hyperactivity disorder (ADHD), can help reduce this type of fatigue.

Participants in the study will receive either methylphenidate or a placebo, which is a tablet that looks like the medication but does not contain any active ingredients. The study is designed to be a crossover trial, meaning that participants will receive both the medication and the placebo at different times during the study. This helps researchers compare the effects of the medication directly with the placebo. The trial will last for a total of six weeks for each treatment phase, and participants will report on their levels of fatigue and other related symptoms throughout the study.

The purpose of this study is to evaluate whether methylphenidate can effectively alleviate cancer-related fatigue in those who have been treated for a pediatric brain tumor. By participating in this trial, researchers hope to gather valuable information that could lead to better management of fatigue in patients who have undergone treatment for brain tumors during their early years. The study will also look at other aspects such as attention, memory, and quality of life to provide a comprehensive understanding of the medication's impact.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Introduction to the trial
The trial is designed to evaluate the effect of methylphenidate on fatigue related to cancer treatment in patients who had a brain tumor during childhood or adolescence.
Participants will be randomly assigned to receive either methylphenidate or a placebo in a double-blind manner, meaning neither the participants nor the researchers will know which treatment is being administered at any given time.
Step 2
Treatment phase 1
Participants will begin the first phase of treatment, receiving either methylphenidate or a placebo orally.
The dosage and frequency of administration will be determined by the study protocol and will be consistent throughout this phase.
This phase will last for a specified period, during which participants will be monitored for changes in fatigue levels and any side effects.
Step 3
Assessment and crossover
At the end of the first treatment phase, participants will undergo assessments to measure changes in fatigue and other related outcomes.
Participants will then switch to the opposite treatment (from methylphenidate to placebo or vice versa) for the second phase of the trial.
Step 4
Treatment phase 2
Participants will begin the second phase of treatment, receiving the opposite treatment from the first phase.
The same monitoring and assessment procedures will be followed as in the first phase.
This phase will also last for a specified period, ensuring consistency in the trial's methodology.
Step 5
Final assessment
Upon completion of the second treatment phase, participants will undergo a final assessment.
This assessment will evaluate changes in fatigue, executive function, and quality of life, among other outcomes.
The results will contribute to understanding the efficacy of methylphenidate in managing cancer-related fatigue.

Who can join the trial?

9 criteria

Must have been diagnosed and treated for a brain tumor during childhood or teenage years, up to 18 years old.
Treatment for the brain tumor must have occurred within the last 10 years, starting from the date of diagnosis.
Must be at least 6 years and 0 months old at the start of the trial.
Must have been off therapy or active treatment for the pediatric brain tumor for at least 12 months at the start of the trial.
No known signs of the tumor getting worse, based on the latest medical check-up.
Danish must be the main language spoken, to ensure understanding of the assessment tools used in the trial.
Consent must be given by the patient and/or their legal guardians to participate in the trial.
Must have significant tiredness, as shown by a specific questionnaire called the PedsQL MFS, with a score that is at least 1 standard deviation below the average.
Must have a history of significant tiredness after treatment for a pediatric brain tumor, compared to their estimated ability before the illness, as assessed during visits to the childhood cancer outpatient clinics.

Who cannot join the trial?

4 criteria

Patients who do not have **cancer-related fatigue** after treatment for a **pediatric brain tumor** cannot participate. **Cancer-related fatigue** is a feeling of extreme tiredness that doesn't go away with rest, and **pediatric brain tumor** refers to a brain tumor that occurred in a child.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups, so if a patient is too young or too old, they may not be eligible.
Patients who are not screened and confirmed to have **cancer-related fatigue** cannot participate. Screening is a process to check if a patient has the specific condition being studied.
Patients who belong to a vulnerable population, which means they might need special protection or care, are not included in this study.

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Verified sites

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Verified
Aalborg University Hospital
Aalborg, Denmark
Verified
Aarhus University Hospital
Aarhus, Denmark
Verified
Odense University Hospital
Odense, Denmark

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Investigated drugs

Methylphenidate is a medication being studied for its potential to reduce fatigue in patients who have been treated for a brain tumor during childhood or adolescence. The trial aims to see if this medication can help alleviate the tiredness and lack of energy that some patients experience after their cancer treatment.

What is already known about the treatment

Methylphenidate – Methylphenidate is typically administered orally in the form of tablets or capsules. It is currently being studied in clinical trials for its potential to alleviate cancer-related fatigue in patients who have been treated for pediatric brain tumors. The main therapeutic indication being explored is the reduction of fatigue symptoms in these patients. At the molecular level, methylphenidate works by increasing the levels of certain neurotransmitters in the brain, such as dopamine and norepinephrine, which can help improve attention and energy levels. It is classified pharmacologically as a central nervous system stimulant.

Investigated diseases

Cancer-related fatigue after treatment of pediatric brain tumor – This condition occurs in children who have undergone treatment for brain tumors and experience persistent tiredness. It is not relieved by rest and can significantly impact daily activities and quality of life. The fatigue is often described as a feeling of exhaustion that affects physical, emotional, and mental well-being. It can interfere with a child's ability to concentrate, perform tasks, and engage in social activities. The condition may also be associated with changes in sleep patterns and reduced motivation. It is a common issue faced by pediatric cancer survivors, affecting their recovery and overall health.