A trial to see if taking a supplement powder helps improve the problem of weight and muscle loss in people with lung cancer (NOURISH)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Lung cancer

Non small cell lung cancer

Small cell lung cancer

Status:

Closed

Phase:

Phase 2

This trial is looking at whether a supplement powder given in combination with a support programme can help stop a weight and muscle loss condition called cachexia (pronounced kak-ek-see-ah).

If you have been diagnosed with lung cancer, it is possible that you may lose weight and feel very weak even though you are eating well. This can be part of a process that affects some people with cancer. It is called cachexia.

Researchers in this trial want to see if mixing a supplement powder into drink will help stop people losing weight and muscle strength. The supplement contains substances that the researchers hope will help to stop muscle breakdown. People taking part in this trial will join a support programme to help medical staff pick up and treat any symptoms of cachexia. Half the group will also take the supplement for 12 weeks. The team will measure weight and muscle strength and see if results are better in those taking the supplement. The main aims of this trial are to

See if this supplement can prevent people with lung cancer losing weight and muscle strength
Find out why some people with cancer are more at risk of weight loss than others.

Who can enter

If you are suitable for this trial, you cancer doctor will ask if you would like to take part. People taking part will

Have been diagnosed with small cell lung cancer or non small cell lung cancer in the last 8 weeks
Be able to eat and drink
Be well enough to be up and about for at least half the day (performance status 0, 1 or 2)

You cannot enter this trial if

Your treatment is aiming to cure your lung cancer
You have already started your first course of radiotherapy or chemotherapy
You are pregnant
You have a device in your chest to control your heart beat (a pacemaker or an internal defibrillator)

Trial design

This trial will recruit 96 people. Everyone will have their planned cancer treatment, which is not part of the trial.

Everyone will also join a symptom support programme, which involves you completing a quick questionnaire on each trial visit. This will help the team pick up on any weight or muscle loss, so they can help to control this.

The next part of the trial is randomised. The people taking part are put into 2 groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

If you are in group 1, you will have the trial supplement. This comes as small packets of powder, which you dissolve in a cup of water or juice. You drink this supplement twice a day, for 12 weeks. You also fill out a diary to record the doses you took, and any you missed.

If you are in group 2, you don’t take the supplement, but simply have the care you would have done if you were not taking part in the trial.

As well as different checks to see how well the trial supplement may be working, both groups also fill out a questionnaire at different points during the trial. The questionnaire will ask about any symptoms you have and how you are feeling. This is called a quality of life study.

Hospital visits

Before you join the trial, you will see the doctor, who will make sure that you are suitable to join the trial.

Everyone taking part will then make 6 visits to the hospital for the trial. The first 5 visits will be 3 weeks apart. You then have the last visit 6 weeks later.

At these visits you will see the nurse and have some tests. These tests include

Checking your heart rate and temperature
Blood tests
Measuring the amount of weight, water and fat in your body
Testing the strength of your grip
Filling out a quick questionnaire as part of the symptom support programme

On two of the visits, you will also have a urine test and a physical examination. Each visit should last about half an hour. Where possible, the team will time these for when you are already at the hospital for your routine treatment.

Side effects

You should not have any side effects from the supplement, but some people may find drinking 2 cups of fluid a day for the trial difficult. If you find the drink difficult to take, do talk to your trial nurse.

You may have a small bruise where you gave your blood sample.

Recruitment start:

17/01/2012

Recruitment end:

01/08/2013

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.

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Questions to ask your doctor about clinical trials

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Dr Joyce Thompson

Supported by

Experimental Cancer Medicine Centre (ECMC)
Marie Curie Cancer Care
NIHR Clinical Research Network: Cancer
National Cancer Research Institute (NCRI) Supportive and Palliative Care (SuPaC)
University of Birmingham

If you have questions about the trial please contact our cancer information nurses

Freephone 0808 800 4040

Email