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Randomized Controlled Trial
. 2008 Jan 29;98(2):300-8.
doi: 10.1038/sj.bjc.6604148. Epub 2008 Jan 8.

Safety, tolerability and pharmacokinetics of intravenous ghrelin for cancer-related anorexia/cachexia: a randomised, placebo-controlled, double-blind, double-crossover study

F Strasser  1 , T A Lutz, M T Maeder, B Thuerlimann, D Bueche, M Tschöp, K Kaufmann, B Holst, M Brändle, R von Moos, R Demmer, T Cerny
Affiliations
Randomized Controlled Trial

Safety, tolerability and pharmacokinetics of intravenous ghrelin for cancer-related anorexia/cachexia: a randomised, placebo-controlled, double-blind, double-crossover study

F Strasser et al. Br J Cancer. .

Abstract

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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Figures

Figure 1
Figure 1
Flow of patients in a randomised, placebo-controlled, double-blind, double-crossover trial of i.v. ghrelin for cancer-related anorexia/cachexia.
Figure 2
Figure 2
Pharmacokinetics of active and total ghrelin of the upper dose patients. BL, baseline; I-V, blood samples week 1 (I: morning fasting; II: immediately before ghrelin infusion (1030); III: during ghrelin infusion; IV: after ghrelin infusion (1130); V: after lunch (1230)); Ia-Va, blood samples week 2; EOS, end of study. P<0.001 for differences of morning fasting level of total ghrelin 3 days after ghrelin or placebo.
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References

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