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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


Strasser, F; Lutz, T A; Maeder, M T; Thuerlimann, B; Bueche, D; Tschöp, M; Kaufmann, K; Holst, B; Brändle, M; von Moos, R; Demmer, R; Cerny, T (2008). Safety, tolerability and pharmacokinetics of intravenous ghrelin for cancer-related anorexia/cachexia: a randomised, placebo-controlled, double-blind, double-crossover study. British Journal of Cancer, 98:300-308.

Abstract

Twenty-one adult patients were randomized to receive ghrelin on days 1 and 8 and placebo on days 4 and 11, or vice versa, given intravenously over a 60– minute period before lunch: 10 received 2µg/kg (lower-dose) ghrelin; 11 received 8µg/kg (upper-dose) ghrelin. Active and total ghrelin, growth-hormone, and IGF-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 tumor growth was observed. The peak increase of growth-hormone, a biological marker of ghrelin action, was 25ng/ml with lower-dose and 42ng/ml with upperdose ghrelin. Morning fasting total ghrelin levels were higher (p<0.05) for upperdose patients at end-of-study (3580pg/ml) than at baseline (990pg/ml). IGF-1 levels did not change. At day 8, 81% of patients preferred ghrelin over placebo and at the end-of-study, 63%. 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.

Twenty-one adult patients were randomized to receive ghrelin on days 1 and 8 and placebo on days 4 and 11, or vice versa, given intravenously over a 60– minute period before lunch: 10 received 2µg/kg (lower-dose) ghrelin; 11 received 8µg/kg (upper-dose) ghrelin. Active and total ghrelin, growth-hormone, and IGF-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 tumor growth was observed. The peak increase of growth-hormone, a biological marker of ghrelin action, was 25ng/ml with lower-dose and 42ng/ml with upperdose ghrelin. Morning fasting total ghrelin levels were higher (p<0.05) for upperdose patients at end-of-study (3580pg/ml) than at baseline (990pg/ml). IGF-1 levels did not change. At day 8, 81% of patients preferred ghrelin over placebo and at the end-of-study, 63%. 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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Additional indexing

Item Type:Journal Article, refereed, further contribution
Communities & Collections:05 Vetsuisse Faculty > Institute of Veterinary Physiology
04 Faculty of Medicine > Center for Integrative Human Physiology
Dewey Decimal Classification:570 Life sciences; biology
610 Medicine & health
Language:English
Date:2008
Deposited On:16 May 2008 15:19
Last Modified:05 Apr 2016 12:23
Publisher:Nature Publishing Group
ISSN:0007-0920
Publisher DOI:https://doi.org/10.1038/sj.bjc.6604148
PubMed ID:18182992
Permanent URL: https://doi.org/10.5167/uzh-2496

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