Effects by daily long term provision of ghrelin to unselected weight‐losing cancer patients

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Abstract
BACKGROUND: The short‐term provision of ghrelin to patients with cancer indicates that there may be benefits from long‐term provision of ghrelin for the palliative treatment of weight‐losing cancer patients. This hypothesis was evaluated in a randomized, double‐blind, phase 2 study.METHODS: Weight‐losing cancer patients with solid gastrointestinal tumors were randomized to receive either high‐dose ghrelin treatment (13 μg/kg daily; n = 17 patients) or low‐dose ghrelin treatment (0.7 μg/kg daily; n = 14 patients) for 8 weeks as a once‐daily, subcutaneous injections. Appetite was scored on a visual analog scale; and food intake, resting energy expenditure, and body composition (dual x‐ray absorpitometry) were measured before the start of treatment and during follow‐up. Serum levels of ghrelin, insulin, insulin‐like growth factor 1, growth hormone (GH), triglycerides, free fatty acids, and glucose were measured. Health‐related quality of life, anxiety, and depression were assessed by using standardized methods (the 36‐item Short Form Health Survey and the Hospital Anxiety and Depression Scale). Physical activity, rest, and sleep were measured by using a multisensor body monitor.RESULTS: Treatment groups were comparable at inclusion. Appetite scores were increased significantly by high‐dose ghrelin analyzed both on an intent‐to‐treat basis and according to the protocol. High‐dose ghrelin reduced the loss of whole body fat (P < .04) and serum GH (P < .05). There was a trend for high‐dose ghrelin to improve energy balance (P < .07; per protocol). Otherwise, no statistically significant differences in outcome variables were observed between the high‐dose and low‐dose groups. Adverse effects were not observed by high‐dose ghrelin, such as serum levels of tumor markers (cancer antigen 125 [CA 125], carcinoembryonic antigen, and CA 19‐9).CONCLUSIONS: The current results suggested that daily, long‐term provision of ghrelin to weight‐losing cancer patients with solid tumors supports host metabolism, improves appetite, and attenuates catabolism. Cancer 2010. © 2010 American Cancer Society.

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