A trial of a drug called methylphenidate for people with tiredness caused by cancer (MePFAC)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
All cancer types
Secondary cancers
Status:
Closed
Phase:
Phase 3
This trial is for people who have moderate or severe tiredness (fatigue) caused by advanced cancer.
Advanced cancer means that the cancer has spread from where it started to another part of the body. It is for people with any type of cancer that cannot be cured.
More about this trial
Many people with advanced cancer have moderate or severe tiredness (fatigue). This can affect people’s daily life, social life and quality of life.
Researchers are looking for ways to help people affected by moderate or severe tiredness. In this trial, they are looking at a drug called methylphenidate.
Methylphenidate helps with your brain activity. It can improve attention and help you concentrate better. Methylphenidate is a possible treatment for children with Attention Deficit Hyperactivity Disorder (ADHD). Researchers think that it may also help people with tiredness caused by cancer.
Everyone taking part in this trial has 1 of the following:
- methylphenidate
- dummy drug (placebo)
The main aim of this trial is to find our whether methylphenidate helps people with tiredness caused by advanced cancer.
Who can enter
The following bullet points list the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you.
Who can take part
You may be able to join this trial if all of the following apply. You:
- have advanced cancer that cannot be cured
- have moderate or severe tiredness (fatigue)
- are receiving palliative care treatment
- have acceptable blood tests results
- are able to swallow and absorb tablets
- are at least 18 years old
- can speak and understand English
- are willing to use effective contraception during treatment and for 6 weeks afterwards if there is any possibility that you or your partner could become pregnant
Who can’t take part
You cannot join this trial if any of these apply.
Medical conditions
You:
- have a neuroendocrine tumour that started in the adrenal glands (phaechromocytoma)
- have an eye condition called glaucoma
- have hyperthyroidism
- have or have had, mental health problems such as severe depression, schizophrenia, borderline personality disorder or you have had suicidal thoughts
- have bipolar disorder that isn’t controlled
- have an infection that isn’t controlled
- have heart problems such as severe high blood pressure, angina that isn't controlled, heart failure or you have had a heart attack in the past year
- have had problems with your brain such as an aneurysm or a stroke in the last year
- have epilepsy or fits (seizures) that aren’t controlled
- have any other medical condition that the trial team think could affect you taking part
Other medicines you are taking
You:
- take clonidine, warfarin or any other drug that is called a monoamine oxidase inhibitor (your doctor can tell you more about this)
- take, or have taken certain drugs to treat depression in the past 2 weeks
- are sensitive to methylphenidate or anything it contains
Other
You:
- are going to have a general anaesthetic in the next 9 weeks
- take or have taken an amount of drugs or alcohol that is a concern for your doctor in the last year
- are taking part in another clinical trial
- are pregnant or breastfeeding
Trial design
This is a phase 3 trial. Researchers hope that around 215 to 230 people will take part.
Screening
First, you see a doctor and answer some questions about your health. You also have a blood test if you haven’t had one recently. Doctors want to find out if your kidneys, liver and thyroid are working well.
The research team also ask to look at your medical records. They want to find out about your cancer and the treatments you have had.
The trial doctor looks at the results of the tests and at your medical records. You then:
- stop the trial if the trial doctor doesn’t think you are well enough to join the 2nd part of this trial
- join the 2nd part of this trial if the trial doctor think you are well enough to take part
Your doctor will tell you which other treatments you might have to help with tiredness if you can’t join the 2nd part of this trial.
Main trial (enrolment)
This part of the trial is randomised. Everyone is put into 1 of the following groups at random:
- methylphenidate
- dummy drug (placebo)
The randomisation happens on the same day as the screening visit. Neither you nor your doctor will be able to decide which group you are in. And neither you nor your doctor will know which drug you are taking. This is a double blind trial.
You take methylphenidate or the dummy drug as a tablet that you swallow whole. You start by taking them twice a day, for a week. At the end of the week, the trial team calls you to see how you are and whether you have had any side effects. Then depending on how you are and the side effects you have had, you either:
- continue to take the same dose of methylphenidate or the dummy drug
- stop taking methylphenidate or the dummy drug
- increase or decrease the dose of methylphenidate or the dummy drug
You continue to see or speak with the trial team every week. And they tell you when to stop, increase or decrease the dose of methylphenidate or the dummy drug.
You take methylphenidate or the dummy drug for up to 10 weeks.
Quality of life
Everyone taking part in the 2nd part of this trial completes quality of life questionnaires before the start of treatment and then after:
- 3 weeks
- 6 weeks
- 10 weeks
The questionnaires ask about how you have been feeling and what side effects you have had.
Hospital visits
You see a doctor and have some tests before taking part. The tests might include:
- a physical examination
- blood tests
- urine test
During treatment, you see or speak with the trial team every week. They ask how you are and whether you have had any side effects. This continues for up to 10 weeks.
After 10 weeks, you see the trial team again. You then continue to see your doctor as part of your normal care.
Side effects
The trial team monitor you during treatment and afterwards. You have a phone number to call them if you are worried about anything. The team will tell you about all the possible side effects before you start the trial.
Doctors think that the most common side effects of methylphenidate are:
- difficulty sleeping
- nervousness
- headaches
Recruitment start:
Recruitment end:
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.
Chief Investigator
Professor P Stone
Supported by
Priment Clinical Trial Unit
National Institute for Health Research (NIHR)
NIHR Health Technology Assessment (HTA) programme
University College London (UCL)
Marie Curie Cancer Care
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
Last review date
CRUK internal database number:
15240
Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.
