tumour cachexia
Conditions
Interventions
Product Name: dronabinol
Pharmaceutical Form: Oral drops*
Pharmaceutical form of the placebo: Oral drops*
Route of administration of the placebo: Oral use
Sponsors
Department of Medicine I, Clinical Dep. f. Oncology, University Hospital,
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with tumour cachexia as patients with a loss of 3% or more of body weight during a period of up to 8 weeks preceding inclusion and fulfilling all in- and exclusion criteria Patients with the following diagnosis according to ICD-10 are eligible: N. Bronchi, C 34.9, no CNS metastases 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: • life expectancy < 2 months • subjects who are not available over a period of at least 8 weeks, • suspected ileus or other intestinal disorders including gastritis or bowel dysfunction • pancreatitis or pancreatic cancer • any known abuse of marijuana or a history of abuse of marijuana • serious concomitant medical illness/concomitant disease(s) which would preclude the patient from participating (e.g., serious psychiatric illness that would interfere with obtaining informed consent etc.), • participation in an experimental trial within the last 4 weeks • subjects where no written informed consent is received • female subjects of child bearing potential in which a pregnancy has not been ruled out by appropriate tests (fertile women must practice adequate contraception throughout the course of the study); • lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to improve weight change resulting from tumour cachexia ;Primary end point(s): weight change;Secondary Objective: • body mass index (BMI) • effect on compartmentalisation. • effect on appetite of patients (VAS). • Calorie count of food intake • effect on quality of life of patients (EORTC QLQ C30) • patient’s judgement / global satisfaction • investigator’s judgement, clinical global impression scale (CGI) • effect on pain during study (consumption of analgesics, if applicable) • safety/tolerance, • death rates in both groups during the 16 weeks following to inclusion in the study (optional) | — |
Countries
Austria
Outcome results
None listed