The use of thalidomide as a treatment for cancer cachexia

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 180

Inclusion Criteria

1. Have a histological or cytological diagnosis of upper gastrointestinal (oesophagus, stomach, small bowel, ampulla or pancreas) adenocarcinoma
2. Have no curative options available which are acceptable to the patient
3. Have lost 5% total of pre-morbid body weight or be actively losing at least 1 kg per month
4. Weight loss may be self-reported or obtained from previous documentation
5. If a patient is using megesterol acetate (Megace, Megestrol) or eicosapentaenoic acid (Maxepa, Omacor, Prosure) and has been on a stable dose for at least 1 month but losing weight at the stated rate despite this they may be included. They will be asked to continue on this same dose for the course of the study.
6. Those using corticosteroids, non-steroidal anti-inflammatory drugs and other nutritional supplements or complementary therapies will not be restricted, the doses used will be recorded at each clinic visit
7. Have a predicted survival of at least 8 weeks
8. Aged over 18 years at the time of entry into the trial
9. Able to understand the information given and to give written informed consent
10. Able to take oral medications
11. Agree to the conditions of use of thalidomide as enumerated
12. Women who have not had their ovaries or uterus removed or who have been post-menopausal for at least 2 years, must have a negative urinary pregnancy test and negative pregnancy tests repeated on a monthly basis until 1 month after completion of the trial

Exclusion Criteria

1. Unable to provide informed consent
2. Involved in any other trial during the study period
3. Received chemotherapy or radiotherapy within the previous 4 weeks
4. Expected to receive chemotherapy or radiotherapy in the following 6 months
5. Using varying doses of megesterol acetate or eicosapentaenoic acid
6. Clinically detectable ascites or oedema
7. Unable to take oral medication
8. Pregnant or breastfeeding
9. Unable or considered unlikely to avoid pregnancy
10. Evidence of peripheral neuropathy, severe constipation, vertigo or vestibular disease
11. Previous adverse reaction to thalidomide
12. Any condition judged by the investigator to make the patient unsuitable for inclusion into the study due to interference with absorption of the drug or the overall interpretation of the data

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the ability of thalidomide, as compared with placebo, to attenuate loss of weight in patients with incurable upper gastrointestinal carcinomas

Secondary Outcome Measures

Name	Time	Method
1. To assess any impact on functional or overall quality of life<br>2. To calculate any change in overall survival<br>3. To calculate any change in lean muscle mass<br>4. To calculate any change in grip strength<br>5. To obtain serum and urinary profiles of factors previously implicated in the development of cachexia for both the control and treated group<br>6. To document the safety and tolerability of thalidomide in patients with incurable upper gastrointestinal adenocarcinomas