Since 1996 a clinical study is prepared at the European Institute for Oncological and Immunological Research in Berlin to examine the effectiveness of cannabis in loss of appetite and severe weight loss (cachexia) in advanced cancer patients. On 2 November the first two patients were enrolled into the long awaited study.

The trial should clarify if the ingestion of a standardized cannabis extract increases appetite, body weight and well-being of cancer patients. The effect of cannabis is compared double-blind and randomized to the effect of THC (dronabinol) and placebo.

The preparation to be tested is an extract of Cannabis sativa standardized on its THC content. One capsule contains 2.5 mg THC. It is manufactured from a high-quality plant extract, produced from the whole plant of biologically cultivated cannabis and worked into soft-gelatine-capsules. For 12 weeks patients with loss of appetite and weight loss of at least 5 per cent will be treated with two capsules of the cannabis preparation, THC or placebo.

Seven centres in Germany and Switzerland are currently active (Charité Centre Berlin, Charité Virchow-Clinic Berlin, Robert- Roessle-Clinic Berlin, University Hospitals of Halle, Bonn and Bern, Clinic Darmstadt). It is intended to enrol a total of 445 patients in 20 European centres within a recruitment phase of 18 months. If these expectations can be realized study results are expected from summer 2001 on.

Prof. Robert Gorter, head of the study till now, left the European Institute for Oncological and Immunological Research on 1 November. The management of the study is taken over conjointly by Prof. Thomas Cerny (Kantonsspital of Saint Gallen, Switzerland), Dr. Florian Strasser (Inselspital Bern, Switzerland) and Dr. Martin Schnelle (European Institute for Oncological and Immunological Research, Berlin).

(Source: Personal communication by Dr. Martin Schnelle)