Nano-Megestrol Acetate for Cancer Cachexia in Advanced Pancreatic Cancer

Summary

Cancer anorexia-cachexia syndrome is a common and severe complication in patients with advanced cancer, with a particularly high prevalence in pancreatic cancer. It is associated with systemic inflammation, metabolic disturbances, and dysregulation of central appetite control, leading to reduced quality of life, poor tolerance to anticancer therapy, and shortened survival. Anticancer treatments, including chemotherapy and immunotherapy, may further exacerbate the development and progression of cachexia. Megestrol acetate is recommended as a first-line treatment for cancer-related anorexia-cachexia syndrome by multiple international and national guidelines, based on its proven effects on appetite stimulation, weight gain, and quality of life improvement. The nanocrystalline formulation of megestrol acetate significantly enhances bioavailability and achieves effective plasma concentrations even in the fasting state, making it particularly suitable for patients with cancer cachexia. This randomized, controlled, prospective study aims to evaluate the efficacy and safety of nanocrystalline megestrol acetate in patients with advanced pancreatic cancer complicated by cancer anorexia-cachexia syndrome. The study will assess improvements in appetite, body weight, nutritional status, and quality of life, and explore the clinical value of early anti-cachexia intervention in the era of immuno-chemotherapy, providing evidence to optimize comprehensive treatment strategies for advanced pancreatic cancer.

Timeline

Start

2026-06-01

Primary completion

2027-12-30

Completion

2028-02-20

Publications

• Background Miyawaki T, Naito T, Yabe M, Kodama H, Nishioka N, Miyawaki E, Mamesaya N, Kobayashi H, Omori S, Wakuda K, Ono A, Kenmotsu H, Murakami H, Mori K, Harada H, Takahashi K, Takahashi T. Impact of weight loss on treatment with PD-1/PD-L1 inhibitors plus chemotherapy in advanced non-small-cell lung cancer. Support Care Cancer. 2022 Feb;30(2):1633-1641. doi: 10.1007/s00520-021-06572-4. Epub 2021 Sep 22.
• Background Betts KA, Gao S, Ray S, Schoenfeld AJ. Real-world safety of first-line immuno-oncology combination therapies for advanced non-small-cell lung cancer. Future Oncol. 2024 Apr;20(13):851-862. doi: 10.2217/fon-2023-0612. Epub 2024 Jan 19.
• Background Hariyanto TI, Kurniawan A. Appetite problem in cancer patients: Pathophysiology, diagnosis, and treatment. Cancer Treat Res Commun. 2021;27:100336. doi: 10.1016/j.ctarc.2021.100336. Epub 2021 Feb 13.
• Background Yeom E, Yu K. Understanding the molecular basis of anorexia and tissue wasting in cancer cachexia. Exp Mol Med. 2022 Apr;54(4):426-432. doi: 10.1038/s12276-022-00752-w. Epub 2022 Apr 6.
• Background Hong SH, Choi KM. Gut hormones and appetite regulation. Curr Opin Endocrinol Diabetes Obes. 2024 Jun 1;31(3):115-121. doi: 10.1097/MED.0000000000000859. Epub 2024 Mar 21.
• Background Rubinic I, Kurtov M, Likic R. Novel Pharmaceuticals in Appetite Regulation: Exploring emerging gut peptides and their pharmacological prospects. Pharmacol Res Perspect. 2024 Aug;12(4):e1243. doi: 10.1002/prp2.1243.
• Background Fearon K, Strasser F, Anker SD, Bosaeus I, Bruera E, Fainsinger RL, Jatoi A, Loprinzi C, MacDonald N, Mantovani G, Davis M, Muscaritoli M, Ottery F, Radbruch L, Ravasco P, Walsh D, Wilcock A, Kaasa S, Baracos VE. Definition and classification of cancer cachexia: an international consensus. Lancet Oncol. 2011 May;12(5):489-95. doi: 10.1016/S1470-2045(10)70218-7. Epub 2011 Feb 4.
• Background Argiles JM, Lopez-Soriano FJ, Stemmler B, Busquets S. Cancer-associated cachexia - understanding the tumour macroenvironment and microenvironment to improve management. Nat Rev Clin Oncol. 2023 Apr;20(4):250-264. doi: 10.1038/s41571-023-00734-5. Epub 2023 Feb 20.

Drugs

Indications