Treatment of Patients Suffering from Tumour Cachexia with Dronabinol (tetrahydrocannabinol) or PlaceboComparison of individually optimised dosages in a double blind, randomised parallel design - Dronabinol for tumour cachexia

• Conditions: tumour cachexia

• Registration Number: EUCTR2007-002968-10-AT
• Lead Sponsor: Department of Medicine I, Clinical Dep. f. Oncology, University Hospital,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10-30
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 74

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

•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified