دورية أكاديمية
Pilot clinical trial of macimorelin to assess safety and efficacy in patients with cancer cachexia
| العنوان: | Pilot clinical trial of macimorelin to assess safety and efficacy in patients with cancer cachexia |
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| المؤلفون: | Megan Herodes, Lindsey J. Anderson, Samuel Shober, Ellen A. Schur, Solomon A. Graf, Nicola Ammer, Ramiro Salas, Marco Marcelli, Jose M. Garcia |
| المصدر: | Journal of Cachexia, Sarcopenia and Muscle, Vol 14, Iss 2, Pp 835-846 (2023) |
| بيانات النشر: | Wiley, 2023. |
| سنة النشر: | 2023 |
| المجموعة: | LCC:Diseases of the musculoskeletal system LCC:Human anatomy |
| مصطلحات موضوعية: | growth hormone secretagogue, macimorelin, ghrelin receptor agonist, cancer cachexia, appetite, Diseases of the musculoskeletal system, RC925-935, Human anatomy, QM1-695 |
| الوصف: | Abstract Background Cancer cachexia is associated with reduced body weight, appetite and quality of life (QOL) with no approved treatments. Growth hormone secretagogues like macimorelin have potential to mitigate these effects. Methods This pilot study assessed the safety and efficacy of macimorelin for 1 week. Efficacy was defined a priori as 1‐week change in body weight (≥0.8 kg), plasma insulin‐like growth factor (IGF)‐1 (≥50 ng/mL) or QOL (≥15%). 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 mg/kg macimorelin or placebo; outcomes were assessed non‐parametrically. Results Participants receiving at least one of either macimorelin dose were combined (N = 10; 100% male; median age = 65.50 ± 2.12) and compared with placebo (N = 5; 80% male; median age = 68.00 ± 6.19). Efficacy criteria achieved: body weight (macimorelin N = 2; placebo N = 0; P = 0.92); IGF‐1 (macimorelin N = 0; placebo N = 0); QOL by Anderson Symptom Assessment Scale (macimorelin N = 4; placebo N = 1; P = 1.00) or Functional Assessment of Chronic Illness Therapy‐Fatigue (FACIT‐F; macimorelin N = 3; placebo N = 0; P = 0.50). No related serious or non‐serious adverse events were reported. In macimorelin recipients, change in FACIT‐F was directly associated with change in body weight (r = 0.92, P = 0.001), IGF‐1 (r = 0.80, P = 0.01), and caloric intake (r = 0.83, P = 0.005), and inversely associated with change in energy expenditure (r = −0.67, P = 0.05). Conclusions Daily oral macimorelin for 1 week 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‐induced reductions in body weight, appetite and QOL in larger studies. |
| نوع الوثيقة: | article |
| وصف الملف: | electronic resource |
| اللغة: | English |
| تدمد: | 2190-6009 2190-5991 |
| العلاقة: | https://doaj.org/toc/2190-5991Test; https://doaj.org/toc/2190-6009Test |
| DOI: | 10.1002/jcsm.13191 |
| الوصول الحر: | https://doaj.org/article/be56647d07604dabab7f078a1659e5a8Test |
| رقم الانضمام: | edsdoj.be56647d07604dabab7f078a1659e5a8 |
| قاعدة البيانات: | Directory of Open Access Journals |
Full Text Finder | تدمد: | 21906009 21905991 |
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| DOI: | 10.1002/jcsm.13191 |