The LUANA (LUng cancer ANamorelin Anorexia) trial protocol has been published: Phase II study of anamorelin for anorexia in people with lung cancer.
Loss of appetite (anorexia) is experienced by most people with lung cancer during the course of their disease and treatment. It is a major contributor to weight loss and can lead to impaired physical capacity and reduced ability of people to cope with and complete their cancer treatment. Despite this, effective and long-term treatments of cancer-associated anorexia are lacking and it remains an area of ongoing clinical need.
Anamorelin HCl is an orally-active selective-ghrelin receptor agonist which has shown appetite-stimulating effects. Several randomised, double-blind, clinical trials in cancer patients have shown that anamorelin HCl safely reversed muscle loss, augmented body weight, improved appetite, and was well tolerated. Nonetheless, these data were not sufficiently demonstrated to inform a registration of anamorelin by regulatory authorities. By contrast to the other studies conducted to date, this study will focus on anorexia, and on informative and clinically relevant endpoints, including the ability to tolerate anti-cancer therapies.
The investigators propose to test anamorelin HCI administered daily for 12 weeks in people with anorexia and lung cancer in this phase II, double-blind, placebo-controlled, parallel-arm, fixed-dose, multi-site study. The establishment of feasibility, desirability and the qualitative data from this study will inform the conduct of a subsequent robust effectiveness phase III trial.
The LUANA trial protocol is registered at the Australian New Zealand Clinical Trials Registry [ACTRN12622000129785] and has been published in PLoS One where it can be freely accessed by readers across the globe (10.1371/journal.pone.0285850).
The authors hypothesise that, “Considering the unmet clinical need for safe and effective treatments for anorexia, anamorelin has the potential to improve anorexia and consequently, improve weight loss and nutritional status. This may lead to increased tolerance to anti-cancer therapies and better function maintenance, thus optimising quality of life for people with lung cancer and, in the future, other cancers.”
Professor David Currow is the Chief Investigator and Dr Mariana Sousa is the lead author, Principal Investigator, and coordinator for the LUANA Trial.
Dr Mariana Sousa MD, PhD, is a Chancellor's Postdoctoral Research Fellow based at the PaCCSC, IMPACCT. She is a physician and researcher with clinical and research interests in cancer-associated symptoms, including treatment-related harms and the impact of health on quality of life. Her postdoctoral fellowship focuses on better understanding cancer cachexia and identifying advances to support patients' nutritional and functional state across the cancer care continuum.