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Safety, tolerability and pharmacokinetics of intravenous ghrelin for cancer-related anorexia/cachexia: A randomised, placebo-controlled, double-blind, double-crossover study.
Br. J. Cancer 98, 300-308 (2008)
Twenty-one adult patients were randomised to receive ghrelin on days 1 and 8 and placebo on days 4 and 11 or vice versa, given intravenously over a 60-min period before lunch: 10 received 2 microg kg(-1) (lower-dose) ghrelin; 11 received 8 microg kg(-1) (upper-dose) ghrelin. Active and total ghrelin, growth hormone (GH), and insulin-like growth factor 1 levels were monitored at baseline (4-5 days before day 1), during treatment days, and at end of study (day 17/18). Drug-related adverse events (assessed by NCI-CTC-toxicity criteria and cardiac examination) did not differ between ghrelin and placebo. No grade 3/4 toxicity or stimulation of tumour growth was observed. The peak increase of GH, a biological marker of ghrelin action, was 25 ng ml(-1) with lower-dose and 42 ng ml(-1) with upper-dose ghrelin. Morning fasting total ghrelin levels were higher (P<0.05) for upper-dose patients at end of study (3580 pg ml(-1)) than at baseline (990 pg ml(-1)). Insulin-like growth factor 1 levels did not change. At day 8, 81% of patients preferred ghrelin to placebo as against 63% at the end of study. Nutritional intake and eating-related symptoms, measured to explore preliminary efficacy, did not differ between ghrelin and placebo. Ghrelin is well tolerated and safe in patients with advanced cancer. For safety, tolerance, and patients' preference for treatment, no difference was observed between the lower- and upper-dose group.
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Publication type
Article: Journal article
Document type
Scientific Article
Language
english
Publication Year
2008
HGF-reported in Year
2008
ISSN (print) / ISBN
0007-0920
e-ISSN
1532-1827
Journal
British Journal of Cancer BJC
Quellenangaben
Volume: 98,
Issue: 2,
Pages: 300-308
Publisher
Nature Publishing Group
Reviewing status
Peer reviewed
Institute(s)
Institute of Diabetes and Obesity (IDO)
PubMed ID
18182992
Erfassungsdatum
2020-02-24