A Randomized Trial of Human Growth Hormone (hGH) vs Placebo in Intensively Treated Haemato-Oncology Patients.
Status:
Completed
Trial end date:
2005-04-01
Target enrollment:
Participant gender:
Summary
About 90% of patients with haemato-oncologic malignancy lose their body muscle mass and also
lose weight either due to chemotherapy induced nausea/vomiting or the high catabolic state
due to fever, sepsis or chemotherapy. This impacts tremendously on the days in hospital and
also on the treatment-related complications. Studies with Human Growth hormone (hGH) have
shown that it increases lean body mass in adult patients with AIDS and animal models of
cancer. At the same time, in vitro studies have shown that hGH has no effect on tumor cell
growth. This study is designed to see if the use of hGH in immunocompromised patients with
haematological malignancies prevents the loss of muscle mass and weight loss to some extent.
This will be a blinded 1:1, randomised study including 150 patients whereby the patients will
either receive hGH or a placebo. The doctors and the nurses will not know what drug the
patient is receiving. Both hGH and the placebo will be given intravenously (if patients are
receiving other intravenous antibiotics or haemopoietic support ) or subcutaneously (if
platelets are above 20 x 109/L) The treatment will start on the first day of treatment and
continue for 6 weeks.