Germany: Study with cannabis in cancer cachexia
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)