A trial looking at a different approach to treating cancer pain (TVT - Two Versus Three Step - Study)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
This trial is comparing different approaches to treating cancer pain.
More about this trial
Many people with cancer have pain and need to take painkillers. You might have simple painkillers such as paracetamol, but you may need to have opioid painkillers.
There are weak opioids such as codeine and strong opioids such as morphine. If simple painkillers don’t relieve your pain, you usually start having weak opioids. If this doesn’t control your pain, you then change to strong opioids. But starting strong opioids (at a low dose) straight away may mean that people have their pain controlled more quickly.
The aim of this trial is to see if people starting strong opioids straight away have better pain control and no more side effects than those who start on weak opioids.
Who can enter
You may be able to enter this trial if
- You have been diagnosed with cancer and have pain
- You scored your pain as at least 4 on a scale of 0 to 10
- You are at least 18 years old
You cannot enter this trial if you
- Have had radiotherapy in the last 6 weeks, or are due to have radiotherapy during the trial period, where in either case it is expected to help your pain
- Have pain from having surgery in the last 4 weeks
- Have certain mental health problems or have difficulties with your memory, understanding or decision making (cognitive impairment)
- Have had regular doses of opioid painkillers in the last 2 weeks
- Have taken more than 2 doses of immediate release opioids in the last 24 hours
Trial design
The trial will recruit 400 people. It is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.
Half the people taking part start having a weak opioid, the other half start with a strong opioid at a low dose. You will know which type of drug you are taking.
The trial team will monitor you for 20 days. A doctor or research nurse will phone you each day to ask about any pain you have and about any side effects from the painkillers. They will also ask you to keep a diary at home to record your pain.
If your pain is not controlled, of if you have side effects, the trial team may change your painkillers. If you are taking a weak opioid and have pain, you may stop taking this and start having a strong opioid.
The trial team may ask you to give a blood sample. They will use this to see if genes can affect how people respond to painkillers. But you don’t have to give this sample for research if you don’t want to. You can still take part in the trial.
Hospital visits
If you are interested in taking part, a member of the trial team will arrange to meet you at a convenient time to discuss the trial. If you do take part, a doctor or nurse will phone you each day.
Side effects
The most common side effects of opioid painkillers include constipation and sickness. But this is usually only when you first start taking them.
Occasionally, if the dose of the painkiller is too high for them, people can have other side effects such as hallucinations, confusion or jerking. The trial team will monitor you closely and if you do have side effects, they will treat these quickly.
We have more information about the side effects of opioids.
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.
Chief Investigator
Professor Marie Fallon
Supported by
European Palliative Care Research Centre
MundiPharma
NHS Lothian
NIHR Clinical Research Network: Cancer
University of Edinburgh
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
