A trial looking at thalidomide for cancer patients with weight loss

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

Cancer type:

Bowel (colorectal) cancer

Oesophageal cancer

Pancreatic cancer

Stomach cancer

Status:

Closed

Phase:

Phase 3

This trial is trying to find out if thalidomide helps cancer patients who have severe weight loss (cachexia).

Cachexia is more complicated than just loss of appetite and weight loss. It is a complex problem that involves changes in metabolism and leads to problems such as muscle wasting.

Cachexia seems to be linked to the production of body chemicals called cytokines. Cancers can produce cytokines in larger amounts than normal. The cytokines can then cause the body to break down fat and muscle faster than normal.

Researchers think that thalidomide may be able to help with cachexia. Thalidomide can reduce the amount of cytokines in the body. So it may be able to slow down, or even stop, the weight loss they cause. Early trial results are promising, but no one is quite sure yet how well it works.

In this trial, some patients will have thalidomide tablets and some will have dummy tablets (placebo tablets). The aim of the trial is to find out if thalidomide can help stop cachexia. And to find out how it affects patients’ quality of life.

Who can enter

You can enter this trial if you

Have cancer of the gullet (oesophagus), stomach (gastric cancer), small bowel (duodenum or ileum) or pancreas
Are not able to have treatment aimed at curing your cancer
Have lost 5% of your body weight or are losing at least 1 kg (2.2 lbs) per month
Are able to take tablets
Are prepared to use reliable contraception and are willing to have a pregnancy test once a month if there is any chance you could become pregnant
Are at least 18 years old

You cannot enter this trial if you

Have had chemotherapy or radiotherapy in the last 4 weeks
Are due to have chemotherapy or radiotherapy in the next 6 months
Are taking varying doses of megesterol acetate (Megace) or eicosapentaenoic acid - if you are taking a stable dose and are still losing weight, you may still be able to join the trial
Are taking part in any other trial
Are pregnant or breastfeeding
Have numbness or tingling in your hands or feet (peripheral neuropathy)
Have severe constipation
Have vertigo, or have dizzy spells caused by vestibular disease of the ear
Have had an allergic reaction to thalidomide in the past

Trial design

This is a randomised trial. It will recruit 180 people into 2 groups. The people taking part will be put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

Group 1 take thalidomide tablets once a day (at night) for 6 months.

Group 2 take dummy tablets (placebo tablets) once a day (at night) for 6 months.

You will fill out a questionnaire before you start treatment, and again at 1 month, 2 months, 3 months and 6 months. It will ask you how you have been feeling and about any side effects you have had. It is called a quality of life questionnaire.

Hospital visits

You will see the doctors and have some tests before you take part in this trial. The tests include

Blood tests
Urine test
Examination of your nervous system (neurological examination)
Height and weight
Body fat measurements
Lean body mass measurements
Grip strength

During the trial you will see the doctors at 1 month, 2 months, 3 months and 6 months. At each visit you will have your body fat and lean body mass measured again. At most visits you will also have blood tests and a urine test. The doctor will ask you how you have been, and give you a supply of tablets to last until your next visit.

A month after you stop taking the thalidomide (or placebo), a member of the research team will phone you to see how you are.