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Growth hormone secretagogues like macimorelin have potential to mitigate these effects.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This pilot study assessed the safety and efficacy of macimorelin for 1\u00a0week. Efficacy was defined <jats:italic>a priori<\/jats:italic> as 1\u2010week change in body weight (\u22650.8\u00a0kg), plasma insulin\u2010like growth factor (IGF)\u20101 (\u226550\u00a0ng\/mL) or QOL (\u226515%). Secondary outcomes included food intake, appetite, functional performance, energy expenditure and safety laboratory parameters. Patients with cancer cachexia were randomized to 0.5 or 1.0\u00a0mg\/kg macimorelin or placebo; outcomes were assessed non\u2010parametrically.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Participants receiving at least one of either macimorelin dose were combined (<jats:italic>N<\/jats:italic>\u00a0=\u00a010; 100% male; median age\u00a0=\u00a065.50\u00a0\u00b1\u00a02.12) and compared with placebo (<jats:italic>N<\/jats:italic>\u00a0=\u00a05; 80% male; median age\u00a0=\u00a068.00\u00a0\u00b1\u00a06.19). Efficacy criteria achieved: body weight (macimorelin <jats:italic>N<\/jats:italic>\u00a0=\u00a02; placebo <jats:italic>N<\/jats:italic>\u00a0=\u00a00; <jats:italic>P<\/jats:italic>\u00a0=\u00a00.92); IGF\u20101 (macimorelin <jats:italic>N<\/jats:italic>\u00a0=\u00a00; placebo <jats:italic>N<\/jats:italic>\u00a0=\u00a00); QOL by Anderson Symptom Assessment Scale (macimorelin <jats:italic>N<\/jats:italic>\u00a0=\u00a04; placebo <jats:italic>N<\/jats:italic>\u00a0=\u00a01; <jats:italic>P<\/jats:italic>\u00a0=\u00a01.00) or Functional Assessment of Chronic Illness Therapy\u2010Fatigue (FACIT\u2010F; macimorelin <jats:italic>N<\/jats:italic>\u00a0=\u00a03; placebo <jats:italic>N<\/jats:italic>\u00a0=\u00a00; <jats:italic>P<\/jats:italic>\u00a0=\u00a00.50). No related serious or non\u2010serious adverse events were reported. In macimorelin recipients, change in FACIT\u2010F was directly associated with change in body weight (<jats:italic>r<\/jats:italic>\u00a0=\u00a00.92, <jats:italic>P<\/jats:italic>\u00a0=\u00a00.001), IGF\u20101 (<jats:italic>r<\/jats:italic>\u00a0=\u00a00.80, <jats:italic>P<\/jats:italic>\u00a0=\u00a00.01), and caloric intake (<jats:italic>r<\/jats:italic>\u00a0=\u00a00.83, <jats:italic>P<\/jats:italic>\u00a0=\u00a00.005), and inversely associated with change in energy expenditure (<jats:italic>r<\/jats:italic>\u00a0=\u00a0\u22120.67, <jats:italic>P<\/jats:italic>\u00a0=\u00a00.05).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Daily oral macimorelin for 1\u00a0week was safe and numerically improved body weight and QOL in patients with cancer cachexia compared with placebo. Longer term administration should be evaluated for mitigation of cancer\u2010induced reductions in body weight, appetite and QOL in larger studies.<\/jats:p><\/jats:sec>","DOI":"10.1002\/jcsm.13191","type":"journal-article","created":{"date-parts":[[2023,3,2]],"date-time":"2023-03-02T06:40:15Z","timestamp":1677739215000},"page":"835-846","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":15,"title":["Pilot clinical trial of macimorelin to assess safety and efficacy in patients with cancer cachexia"],"prefix":"10.1002","volume":"14","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9844-0375","authenticated-orcid":false,"given":"Megan","family":"Herodes","sequence":"first","affiliation":[{"name":"Division of Gerontology and Geriatric Medicine, School of Medicine University of Washington  Seattle WA USA"},{"name":"Geriatric Research, Education and Clinical Center Veterans Affairs Puget Sound Health Care System  Seattle WA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lindsey J.","family":"Anderson","sequence":"additional","affiliation":[{"name":"Division of Gerontology and Geriatric Medicine, School of Medicine University of Washington  Seattle WA USA"},{"name":"Geriatric Research, Education and Clinical Center Veterans Affairs Puget Sound Health Care System  Seattle WA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Samuel","family":"Shober","sequence":"additional","affiliation":[{"name":"Division of Gerontology and Geriatric Medicine, School of Medicine University of Washington  Seattle WA USA"},{"name":"Geriatric Research, Education and Clinical Center Veterans Affairs Puget Sound Health Care System  Seattle WA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ellen A.","family":"Schur","sequence":"additional","affiliation":[{"name":"Division of General Internal Medicine, Department of Medicine University of Washington  Seattle WA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Solomon A.","family":"Graf","sequence":"additional","affiliation":[{"name":"Hospital and Specialty Medicine Veterans Affairs Puget Sound Health Care System  Seattle WA USA"},{"name":"Division of Medical Oncology, Department of Medicine University of Washington  Seattle WA USA"},{"name":"Clinical Research Division Fred Hutchinson Cancer Center  Seattle WA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicola","family":"Ammer","sequence":"additional","affiliation":[{"name":"Department of Clinical Development Aeterna Zentaris GmbH  Frankfurt Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ramiro","family":"Salas","sequence":"additional","affiliation":[{"name":"Departments of Psychiatry and Neuroscience Baylor College of Medicine  Houston TX USA"},{"name":"The Menninger Clinic  Houston TX USA"},{"name":"Center for Translational Research on Inflammatory Diseases Michael E. 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