@article{b65e943a80d148c09f3e1d38004176e7,
title = "Overcoming obstacles in the design of cancer anorexia/weight loss trials",
abstract = "Most advanced cancer patients suffer loss of appetite (anorexia) and loss of weight. Despite the fact that cancer anorexia and weight loss are associated with a poor prognosis and detract from quality of life, no interventions have been demonstrated to palliate this syndrome in its entirety, particularly in patients with treatment-refractory malignancies. Recently, two registration trials − one with anamorelin and another with enobosarm − failed to reach their primary endpoints, thus raising questions. Were both these agents ineffective? Alternatively, did study design issues compromise the ability of these trials to identify effective agents? Thus, this review is timely insofar it serves as an introduction to study design, offers guidance on how to test promising agents for cancer anorexia/weight loss, and provides advice for overcoming trial design obstacles.",
keywords = "Anorexia, Cancer, Study design, Weight loss",
author = "Le-Rademacher, {Jennifer G.} and Jeffrey Crawford and Evans, {William J.} and Aminah Jatoi",
note = "Funding Information: Source: This work was partially supported by the National Institutes of Health [grant number R01CA195473 ]. Dr. Le-Rademacher is the lead statistician within the Cancer Control Program at the Mayo Clinic and holds a long track record of designing and overseeing clinical trials in cancer patients. She holds special interest in understanding methodological issues in clinical trials. Dr. Crawford is a practicing medical oncologist with an interest in lung cancer therapeutics. He has been involved in multiple clinical trials, including multi-institutional clinical trials. Dr. Evans holds interests in geriatrics and functional reserve and has published extensively in these areas. He has special interests in understanding issues as relevant to resilience in older individuals. Dr. Jatoi is a practicing medical oncologist with interests in supportive care issues, including cancer-associated weight loss. She has conducted numerous clinical trials in cancer-associated weight loss. Publisher Copyright: {\textcopyright} 2017 Elsevier B.V.",
year = "2017",
month = sep,
doi = "10.1016/j.critrevonc.2017.06.008",
language = "English (US)",
volume = "117",
pages = "30--37",
journal = "Critical Reviews in Oncology/Hematology",
issn = "1040-8428",
publisher = "Elsevier Ireland Ltd",
}