Cachexia associated with upper gastrointestinal adenocarcinoma Cancer Malignant neoplasm of other and ill-defined digestive organs
Conditions
Interventions
Thalidomide or placebo
Sponsors
Portsmouth Hospitals Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the ability of thalidomide, as compared with placebo, to attenuate loss of weight in patients with incurable upper gastrointestinal carcinomas | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To assess any impact on functional or overall quality of life 2. To calculate any change in overall survival 3. To calculate any change in lean muscle mass 4. To calculate any change in grip strength 5. To obtain serum and urinary profiles of factors previously implicated in the development of cachexia for both the control and treated group 6. To document the safety and tolerability of thalidomide in patients with incurable upper gastrointestinal adenocarcinomas | — |
Countries
United Kingdom
Outcome results
None listed