A trial looking at orvepitant to relieve itchiness caused by cancer treatment (RELIEVE 1)
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 looking at a drug called orvepitant to relieve itchiness caused by a cancer treatment. The trial is for people with a solid tumour whose cancer has epidermal growth factor receptors (
). A solid tumour is any cancer apart from or .
Doctors treat EGFR positive cancers with biological therapies called cancer growth blockers. As with all treatments there are side effects. One of the most common side effects of these is severe itchiness. This can be so bad that it can lead to an interruption in your cancer treatment as well as affecting your , in particular how well you sleep at night.
We know from research that drugs similar to orvepitant can help people with itchiness. The researchers want to find out if orvepitant can help people with this side effect.
The aims of this trial are to compare orvepitant with a dummy drug () to find out
- How well orvepitant works to reduce itchiness
- What effect orvepitant has on people’s quality of life
- How safe orvepitant is
Who can enter
You may be able to join this trial if all of the following apply. You
- Have a
solid tumour - Are having a drug that blocks
epidermal growth factor protein , such as erlotinib or cetuximab, and it is causing severe itchiness - Have satisfactory blood test results
- Are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
- Are willing to use reliable contraception during treatment if there is any chance you or your partner could become pregnant
- Are at least 18 years old
You cannot join this trial if any of these apply. You
- Have cancer that has spread to your brain
- Have had treatment for itchiness in the past 3 months apart from itchiness caused by the drug that blocks epidermal growth factor protein
- Have had drugs similar to orvepitant in the past 4 weeks (your doctor can tell you this)
- Have taken an experimental drug as part of another clinical trial in the past month
- Are taking certain types of medication (the trial team can advise you about this)
- Are allergic to orvepitant or its ingredients
- Have had fits (seizures) in the past
- Have had an injury to your head or brain
- Have any other serious medical or mental health problems that the trial team thinks could affect you taking part in this trial
- Are pregnant or breastfeeding
Trial design
This is a phase 2 trial. The researchers need 40 people to join this trial.
It is a randomised trial. The people taking part are put into 1 of 2 treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. And neither of you will know which group you are in. This is called a double blind trial.
- People in group 1 have orvepitant
- People in group 2 have a dummy drug (placebo)
Orvepitant and the dummy drug are tablets you take once a day for 4 weeks.
Every evening during the 4 weeks you need to make a call using a Freephone number. You will be asked 2 questions about how itchy you are. Your doctor or nurse will give you a leaflet about this and will tell you what you need to do.
Or if you prefer you can use a diary to record each day how itchy you are. Your doctor or nurse will tell you how to do this.
The trial team will ask you to fill out questionnaires before you start treatment, when you start treatment, the 1st and last week of treatment and 4 weeks after you finish treatment. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.
Hospital visits
You see the doctor to have some tests before taking part in this trial. These tests include
- A physical examination
- Blood tests
- Urine test
- Heart trace (
ECG )
You see the doctor for the same tests
- When you start treatment
- When you finish treatment (at 4 weeks)
- 4 weeks after finishing treatment
Side effects
The most common side effects of orvepitant include
- Headache
- Dry mouth
- Dizziness
- Being aware of your heart beating strongly (palpitations)
- Sleepiness
- Diarrhoea
- Tiredness
- Feeling sick
Your doctor will talk to you about all the possible side effects before you agree to take part in the trial.
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 Ruth Plummer
Supported by
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
NeRRe Therapeutics Ltd
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
