CompletedNot ApplicableInterventional

MePFAC - A Drug Trial for the treatment of cancer-related Fatigue

Cancer-related fatigue is not like everyday tiredness; resting or sleeping often does not make it better. It can have a big impact on daily life, mood, and well-being. The MePFAC clinical trial is testing whether a medicine called methylphenidate can help relieve severe fatigue in people living with advanced cancer. Methylphenidate is a medication already used for other conditions to improve alertness. In this study, researchers want to see if it can safely boost physical energy and quality of life for cancer patients. Half of the people taking part will receive methylphenidate, and the other half will receive a dummy tablet (placebo). The trial lasts for ten weeks. During this time, the study team will track your energy levels, symptoms, and overall health to find out if the treatment makes a genuine difference.

At a glance

Status

Completed

Phase

Not Applicable

Sponsor

University College London

Enrolment target

230

Start

15 Jan 2018

Estimated completion

27 Apr 2023

Psychosocial Oncology and Survivorship

What is this study about?

Living with advanced cancer often brings overwhelming exhaustion. Cancer-related fatigue is very different from ordinary tiredness. It does not go away after a good night's sleep, and it can make even small daily activities feel exhausting. Doctors are searching for reliable ways to help people feel more awake, comfortable, and energised.

The MePFAC trial is testing a medicine called methylphenidate to see if it can help reduce this severe tiredness. Methylphenidate is already commonly prescribed for other health conditions to help people stay alert and focused. Researchers want to discover whether it can give people with advanced cancer a meaningful boost in energy.

To see if the medicine really works, the study compares methylphenidate against a dummy tablet, known as a placebo. Neither you nor your doctor will choose or know which pill you are taking. Comparing the medicine to a placebo is the fairest way to show whether changes in energy come from the drug itself.

If the results are positive, this trial could provide NHS palliative care teams with a helpful new tool to treat fatigue, helping future patients enjoy a better quality of life.

Key takeaways

Tests whether methylphenidate tablets help ease severe cancer-related fatigue.
Open to adults with advanced, incurable cancer who feel moderately or severely tired.
Compares the active medicine against a dummy pill (placebo) over ten weeks.
You will be asked to track your energy and symptoms through regular check-ins.
Taking part is voluntary, and you can withdraw at any time.

Who may be eligible?

You may be able to join this study if you are 18 or older and have been diagnosed with advanced cancer that cannot be cured. You must be experiencing moderate or severe tiredness (rated at least 4 out of 10 on a simple scale) and currently be supported by a palliative care team or your GP.

To take part, you will need to be well enough to complete a ten-week study and happy for the trial team to let your GP know you are participating. You must also be able to understand the trial details and give your consent.

You cannot join if you are pregnant. If you or your partner could become pregnant, you must agree to use reliable contraception during the trial and for six weeks after stopping the study medicine.

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.

I am 18 years of age or older.
I have been diagnosed with advanced, incurable cancer.
I have moderate to severe tiredness (rated over 3 out of 10).
I am currently receiving support from a palliative care team or my GP.
I am able to take part in study visits and questionnaires for ten weeks.
I am not pregnant and agree to use effective contraception if needed.

Answer every question to see your result.

What does participation involve?

Taking part in this study lasts for ten weeks. During this period, you will be asked to take a daily tablet, which will be either methylphenidate or a dummy pill (placebo). You will have regular appointments with the research team, either at a clinic or over the phone, to see how you are feeling. You will be asked to fill in short questionnaires about your energy levels, sleep, and quality of life. The team will also check your blood pressure, heart rate, and overall health to make sure the tablets are suiting you well. Your GP will be kept updated throughout the process.

Potential risks and benefits

You might experience an improvement in your energy levels and daily comfort, but this cannot be guaranteed, especially since you might receive a dummy pill. Methylphenidate can also cause side effects, such as a reduced appetite, trouble sleeping, mild restlessness, or slight increases in heart rate and blood pressure. The team will monitor you closely to manage any issues. Taking part is completely voluntary, and you are free to leave the trial at any time without giving a reason and without it affecting your standard NHS care.

Locations (11)

University College London Hospital
City only
London, England
Martlets Hospice
Approximate
Hove, England
Brighton General Hospital
Approximate
Brighton, England
Leeds Community Healthcare NHS Trust
Approximate
Leeds, England
Marie Curie Hospice
Approximate
London, England
Pilgrims Hospices
Unverified
Canterbury, England
Stephenson House
Unverified
London, England
LOROS
Unverified
Leicester, England
Nottinghamshire Healthcare NHS Foundation Trust
Unverified
Nottingham, England
Queens Medical Centre
Unverified
Nottingham, England
Leckhampton Court Hospice
Unverified
Leckhampton, England

Common questions

What is methylphenidate?

Methylphenidate is a prescription medicine that stimulates the central nervous system. It is commonly used to treat conditions like ADHD to improve alertness, and doctors are testing if it can safely reduce severe cancer tiredness.

Can I choose whether I receive the real medicine or the placebo?

No. A computer randomly decides who gets methylphenidate and who gets the dummy pill. This ensures the trial results are fair and unbiased.

Do I have to stop my usual cancer treatments to take part?

Usually, you can continue your supportive treatments and palliative care. Your medical team will double-check that the study medicine is safe to take alongside your current prescriptions.

Will taking part cost me anything?

No, the study medication and any extra trial-related check-ups are provided free of charge. You may also be able to get help with travel costs for clinic visits.

What happens if I change my mind during the trial?

You can step down from the study at any point. Deciding to stop will never affect the quality of your regular medical or palliative care.

How to find out more

Elli Enayat

z.enayat@ucl.ac.uk +44 20 7679 9269 (ext 09269) Official trial record

Always speak to your GP or specialist before deciding to take part in a study.