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Randomised placebo-controlled cross-over study examining the role of anamorelin in mesothelioma (The ANTHEM study): rationale and protocol
INTRODUCTION: Cachexia is common in malignant mesothelioma (MM); half of patients have malnutrition and low skeletal muscle mass. Malnourished patients have worse quality of life (QoL). Weight loss is strongly associated with poor survival. Anamorelin is an oral ghrelin receptor agonist that improve...
Autores principales: | , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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BMJ Publishing Group
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7173983/ https://www.ncbi.nlm.nih.gov/pubmed/32213537 http://dx.doi.org/10.1136/bmjresp-2019-000551 |
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author | Hoon, Siao Nge Fyfe, Katrina Peddle-McIntyre, Carolyn J Bowyer, Samantha Hawkins, Felicity Jeffery, Emily Chih, Hui Jun Creaney, Jenette Nowak, Anna Brims, Fraser |
author_facet | Hoon, Siao Nge Fyfe, Katrina Peddle-McIntyre, Carolyn J Bowyer, Samantha Hawkins, Felicity Jeffery, Emily Chih, Hui Jun Creaney, Jenette Nowak, Anna Brims, Fraser |
author_sort | Hoon, Siao Nge |
collection | PubMed |
description | INTRODUCTION: Cachexia is common in malignant mesothelioma (MM); half of patients have malnutrition and low skeletal muscle mass. Malnourished patients have worse quality of life (QoL). Weight loss is strongly associated with poor survival. Anamorelin is an oral ghrelin receptor agonist that improves appetite, body weight and QoL in advanced cancer. The aim of this study is to examine the efficacy of anamorelin in improving appendicular skeletal muscle mass (ASM) and patient-reported outcomes in patients with MM with cachexia. METHODS AND ANALYSIS: A single-centre, phase II, randomised, placebo-controlled cross-over pilot study with 28-day treatment periods and 3-day washout. Forty patients will be randomised. Primary outcome is change in ASM relative to height measured by dual energy X-ray absorptiometry at end of period 1. Secondary outcomes include cancer-specific and cachexia-related QoL, objective physical activity, dietary intake and adverse events. Eligible patients will have confirmed MM, Eastern Cooperative Oncology Group 0–2, expected survival >3 months and cachexia (defined as >5% weight loss in 6 months or body mass index <20 kg/m(2) with weight loss >2%). ETHICS AND DISSEMINATION: Ethical approval has been granted. Results will be reported in peer-reviewed publications. TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry (U1111-1240-6828). |
format | Online Article Text |
id | pubmed-7173983 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-71739832020-04-27 Randomised placebo-controlled cross-over study examining the role of anamorelin in mesothelioma (The ANTHEM study): rationale and protocol Hoon, Siao Nge Fyfe, Katrina Peddle-McIntyre, Carolyn J Bowyer, Samantha Hawkins, Felicity Jeffery, Emily Chih, Hui Jun Creaney, Jenette Nowak, Anna Brims, Fraser BMJ Open Respir Res Pleural Disease INTRODUCTION: Cachexia is common in malignant mesothelioma (MM); half of patients have malnutrition and low skeletal muscle mass. Malnourished patients have worse quality of life (QoL). Weight loss is strongly associated with poor survival. Anamorelin is an oral ghrelin receptor agonist that improves appetite, body weight and QoL in advanced cancer. The aim of this study is to examine the efficacy of anamorelin in improving appendicular skeletal muscle mass (ASM) and patient-reported outcomes in patients with MM with cachexia. METHODS AND ANALYSIS: A single-centre, phase II, randomised, placebo-controlled cross-over pilot study with 28-day treatment periods and 3-day washout. Forty patients will be randomised. Primary outcome is change in ASM relative to height measured by dual energy X-ray absorptiometry at end of period 1. Secondary outcomes include cancer-specific and cachexia-related QoL, objective physical activity, dietary intake and adverse events. Eligible patients will have confirmed MM, Eastern Cooperative Oncology Group 0–2, expected survival >3 months and cachexia (defined as >5% weight loss in 6 months or body mass index <20 kg/m(2) with weight loss >2%). ETHICS AND DISSEMINATION: Ethical approval has been granted. Results will be reported in peer-reviewed publications. TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry (U1111-1240-6828). BMJ Publishing Group 2020-03-25 /pmc/articles/PMC7173983/ /pubmed/32213537 http://dx.doi.org/10.1136/bmjresp-2019-000551 Text en © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/. |
spellingShingle | Pleural Disease Hoon, Siao Nge Fyfe, Katrina Peddle-McIntyre, Carolyn J Bowyer, Samantha Hawkins, Felicity Jeffery, Emily Chih, Hui Jun Creaney, Jenette Nowak, Anna Brims, Fraser Randomised placebo-controlled cross-over study examining the role of anamorelin in mesothelioma (The ANTHEM study): rationale and protocol |
title | Randomised placebo-controlled cross-over study examining the role of anamorelin in mesothelioma (The ANTHEM study): rationale and protocol |
title_full | Randomised placebo-controlled cross-over study examining the role of anamorelin in mesothelioma (The ANTHEM study): rationale and protocol |
title_fullStr | Randomised placebo-controlled cross-over study examining the role of anamorelin in mesothelioma (The ANTHEM study): rationale and protocol |
title_full_unstemmed | Randomised placebo-controlled cross-over study examining the role of anamorelin in mesothelioma (The ANTHEM study): rationale and protocol |
title_short | Randomised placebo-controlled cross-over study examining the role of anamorelin in mesothelioma (The ANTHEM study): rationale and protocol |
title_sort | randomised placebo-controlled cross-over study examining the role of anamorelin in mesothelioma (the anthem study): rationale and protocol |
topic | Pleural Disease |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7173983/ https://www.ncbi.nlm.nih.gov/pubmed/32213537 http://dx.doi.org/10.1136/bmjresp-2019-000551 |
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