Nano-Megestrol Acetate for Cancer Cachexia in Advanced Pancreatic Cancer

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.

NCT Number	NCT07408505
Lead Sponsor	Shandong Cancer Hospital and Institute
Conditions	Advanced Pancreatic Ductal Adenocarcinoma, Cancer Anorexia-Cachexia Syndrome
Enrollment	56 participants
Start Date	2026-06-01
Primary Completion	2027-12-30 (estimated)
Study Completion	2028-02-20 (estimated)
Updated on ClinicalTrials.gov	2026-04-27