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Nano-Megestrol Acetate for Cancer Cachexia in Advanced Pancreatic Cancer

NCT07408505 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2026-04-27

No results posted yet for this study

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.

Conditions

  • Advanced Pancreatic Ductal Adenocarcinoma
  • Cancer Anorexia-Cachexia Syndrome

Interventions

DRUG

Nano-crystalline megestrol acetate

Nano-crystalline megestrol acetate is administered as an oral suspension at a dose of 625 mg once daily (5 mL, 125 mg/mL) starting concurrently with first-line chemotherapy and continued for up to 12 weeks. Unlike conventional megestrol acetate formulations, the nano-crystalline formulation utilizes reduced particle size to enhance oral bioavailability and improve weight gain outcomes. In this study, nano-crystalline megestrol acetate is used as an early supportive intervention in treatment-naïve patients with advanced pancreatic cancer-related anorexia-cachexia syndrome, rather than as salvage therapy. The intervention is delivered in combination with standard first-line chemotherapy regimens (AG, FOLFIRINOX, or NALIRIFOX). Administration of nano-crystalline megestrol acetate may be continued even if modifications, delays, or discontinuation of chemotherapy occur, in accordance with the study protocol. Safety and efficacy are prospectively monitored throughout treatment and follow-up.

DRUG

First-line Chemotherapy

Participants in the control group will receive first-line chemotherapy alone, without nano-crystalline megestrol acetate. Chemotherapy regimens, including AG, FOLFIRINOX, or NALIRIFOX, will be selected and managed according to standard clinical practice.

Sponsors & Collaborators

  • Shandong Cancer Hospital and Institute

    lead OTHER

Principal Investigators

  • Jinbo Yue, Dorcter · Shandong Cancer Hospital and Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2027-12-30
Completion
2028-02-20

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07408505 on ClinicalTrials.gov