Nano-Megestrol Acetate for Cancer Cachexia in Advanced Pancreatic Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShandong Cancer Hospital and Institute
About this trial
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.
Eligibility criteria
Qualifiers
Histologically or cytologically confirmed locally advanced or metastatic pancreatic ductal adenocarcinoma according to the TNM staging system of the International Association of Pancreatology and the 8th edition of the American Joint Committee on Cancer (AJCC);
No prior systemic antitumor therapy for recurrent or metastatic disease;
Prior adjuvant or neoadjuvant chemotherapy, radiotherapy, chemoradiotherapy, or immunotherapy for non-metastatic disease is allowed, provided that at least 6 months have elapsed since completion of the last treatment without disease recurrence;
At least one measurable lesion according to RECIST version 1.1 (previously irradiated lesions may be considered measurable only if there is clear evidence of disease progression after radiotherapy).
Disqualifiers
Active or untreated CNS metastases (e.g., brain or leptomeningeal metastases) as determined by CT or magnetic resonance imaging (MRI) during screening or based on prior imaging assessments. Patients with previously treated brain or leptomeningeal metastases may be eligible if the disease has been stable for ≥ 2 months and systemic corticosteroid therapy (>10 mg/day prednisone or equivalent) has been discontinued for > 4 weeks prior to randomization.
Uncontrolled tumor-related pain;
Women who are pregnant, breastfeeding, or planning to become pregnant during the study period;
Patients with a positive test result for human immunodeficiency virus (HIV);
Trial design
Treatments tested in this trial
- Nano-crystalline megestrol acetate
- First-line Chemotherapy
Treatment groups
56 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov