Safety, tolerability and pharmacokinetics of intravenous ghrelin for cancer-related anorexia/cachexia: a randomised, placebo-controlled, double-blind, double-crossover study
| Autor: | Florian Strasser, M. Brandle, R. Demmer, M T Maeder, R. von Moos, Birgitte Holst, Matthias H. Tschöp, B. Thuerlimann, Karin Kaufmann, Thomas A. Lutz, D. Bueche, Thomas Cerny |
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| Přispěvatelé: | University of Zurich, Strasser, F |
| Jazyk: | angličtina |
| Rok vydání: | 2008 |
| Předmět: |
Male
Cancer Research medicine.medical_specialty Randomization Cachexia 610 Medicine & health Anorexia Placebo Placebos Double-Blind Method Internal medicine Neoplasms Clinical Studies Medicine Humans 1306 Cancer Research Adverse effect Infusions Intravenous Aged Aged 80 and over Cross-Over Studies Anamorelin business.industry digestive oral and skin physiology Middle Aged 10081 Institute of Veterinary Physiology medicine.disease Crossover study Ghrelin Endocrinology nutrition Oncology 10076 Center for Integrative Human Physiology 570 Life sciences biology 2730 Oncology Female medicine.symptom business hormones hormone substitutes and hormone antagonists Algorithms |
| Zdroj: | British Journal of Cancer |
| ISSN: | 1532-1827 0007-0920 |
| Popis: | 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 (P0.05) 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. |
| Databáze: | OpenAIRE |
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