The cachexia associated with terminal gastrointestinal adenocarcinomas
Conditions
Interventions
Product Name: Thalidomide
Pharmaceutical Form: Capsule, hard
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: O
Sponsors
Portsmouth Hospitals Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ·Have a histological or cytological diagnoisis of upper gastrointestinal adenocarcinoma. ·Have no curative options available that are acceptable to the patient ·Have a predicted survival of at least 4 weeks. ·Aged over 18 years at the time to entry into the trial. ·Able to understand the information given and to give written informed consent. ·Able to take oral medications. ·Agree to the conditions of use of Thalidomide as enumerated (see appendix) ·Women under the age of 54, and those over 54 but still menstruating, must have a negative urinary pregnancy test and negative pregnancy tests repeated on a monthly basis until one month after completion of the trial Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: ·Unable to provide informed consent ·Involved in any other trial during the study period ·Pregnant or breast feeding ·Unable or considered unlikely to avoid pregnancy ·Evidence of peripheral neuropathy, severe constipation, vertigo or vestibular disease ·Unable to take oral medication ·Previous adverse reaction to Thalidomide ·Any condition which is judged by the investigator to make the patient unsuitable for inclusion into the study such as severe concurrent hepatic, renal, haematological, gastrointestinal, endocrine, neurological, pulmonary, or cardiac disease ·Abnormal haematological or biochemical blood results at screening considered by the investigator to make the patient unsuitable for inclusion into the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The assess the ability of Thalidomide to attenuate or reverse the weight loss and weakness experienced by those with incurable gastrointestinal adenocarcinomas;Secondary Objective: To assess the ability of Thalidomide to extend the survival times of those with terminal gastrointestinal adenocarcinomas. The assess the effect on circulating levels of cytokines and tumour factors previously implicated in the development of cachexia. To assess the safety and tolerability in of Thalidomide in this patient group.;Primary end point(s): Rate of clinical response as defined by attenuation of weight loss or improvement in quality of life. | — |
Countries
United Kingdom
Outcome results
None listed