A trial looking at treatment for extreme tiredness and exhaustion in people with advanced lung cancer

Please note this trial is no longer recruiting patients.

This trial is looking at a drug called modafinil for the treatment of extreme tiredness and exhaustion (fatigue) in people with advanced non small cell lung cancer.

Fatigue is one of the most common symptoms that people with lung cancer have and it can greatly affect their quality of life. Doctors are trying to find ways to help relieve this symptom.

Modafinil is a stimulant drug. It has been used for many years to treat medical conditions that cause people to be very sleepy during the day, such as narcolepsy. The research team has already carried out a small pilot study, which looked at giving modafinil to people with lung cancer. It appeared to give some promising results. But they want to know for certain that it is helpful, and so they need to do larger studies.

The aim of this trial is to find out how helpful modafinil is in treating fatigue for people with advanced lung cancer. Half the people taking part will have modafinil and the other half will have a dummy drug (placebo).

Please note: You can only take part if you are being seen at one of the hospitals involved in the trial. Your doctor will ask if you are interested in the trial at one of your clinic appointments.

Recruitment

Start 15/07/2009

End 29/03/2012

Phase

Phase 4

Who can enter

You can enter this trial if

You have stage 3 or stage 4 non small cell lung cancer (NSCLC), or NSCLC that has come back after surgery or radiotherapy (recurrence)
You are well enough to take part (performance status 0,1 or 2)
You rate your level of tiredness as 5 or more on a scale of 1 to 10 (your doctor will tell you more about this)
You are at least 18 years old

You cannot enter this trial if

You have had radiotherapy or chemotherapy in the last 4 weeks
You have started anti depressants or steroids in the last 2 weeks
You have started taking drugs that block a growth factor called EGF such as gefitinib or erlotinib in the last 6 weeks
You have had a blood transfusion in the last 2 weeks
You have had hospital treatment for a mental health problem
There is a possibility that you may become pregnant during the time you are on the study
You have had treatment for an abnormal heart rhythm (arrhythmia)
You have high blood pressure which is not controlled or have any other heart problems
You are taking medicines to help thin your blood, such as warfarin
You are allergic to modafinil or similar stimulant drugs
You are due to have a general anaesthetic for surgery or any other procedure while you are on the study
You have any other medical condition that stops you from taking part
You are taking medication as part of another clinical trial

Trial design

This trial will recruit 206 people in total. It is a randomised trial. You will be put into one of two treatment groups by a computer. Neither you nor your doctor will be able to choose which group you are in, or will be told which group you are in. This is called a double blind trial.

One group will take modafinil tablets and the other will take dummy tablets (placebo).

You take 1 tablet every morning for 2 weeks, then 2 tablets every morning for the following 2 weeks.

Before you start treatment, your doctor will take a blood sample for routine tests. During the study, your doctor will ask you about how you are feeling and any side effects you may have.

Hospital visits

You have 3 extra visits to the hospital as part of this trial. They are

The day before treatment starts
2 weeks afterwards
When treatment finishes

At each visit, the research team will fill out some questionnaires about how tired, sleepy or depressed you feel. If you do not feel well enough to go to the hospital, they can do this over the phone. But you will need to go to hospital if you are taking medication for high blood pressure. This is so that the doctors can measure your blood pressure.