Randomised placebo-controlled cross-over study examining the role of anamorelin in mesothelioma (The ANTHEM study): Rationale and protocol

Authors

Siao Nge Hoon
Katrina Fyfe
Carolyn J. Peddle-McIntyre, Edith Cowan UniversityFollow
Samantha Bowyer
Felicity Hawkins
Emily Jeffery
Hui Jun Chih
Jenette Creaney
Anna Nowak
Fraser Brims

Document Type

Journal Article

Publication Title

BMJ Open Respiratory Research

Publisher

BMJ Publishing Group

School

Exercise Medicine Research Institute

RAS ID

34113

Funders

Cancer Council Western Australia: RES-HEA-CMS-KC-59836-1

Comments

Hoon, S. N., Fyfe, K., Peddle-McIntyre, C. J., Bowyer, S., Hawkins, F., Jeffery, E., ... Brims, F. (2020). Randomised placebo-controlled cross-over study examining the role of anamorelin in mesothelioma (The ANTHEM study): Rationale and protocol. BMJ Open Respiratory Research, 7(1), Article e000551. https://doi.org/10.1136/bmjresp-2019-000551

Abstract

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). © © 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.

DOI

10.1136/bmjresp-2019-000551

Creative Commons License

This work is licensed under a Creative Commons Attribution 4.0 License.