Actively Recruiting
Nano-Megestrol Acetate for Cancer Cachexia in Advanced Pancreatic Cancer
Led by Shandong Cancer Hospital and Institute · Updated on 2026-04-27
56
Participants Needed
1
Research Sites
89 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Nano-Megestrol Acetate for Cancer Cachexia in Advanced Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed locally advanced or metastatic pancreatic ductal adenocarcinoma
- No prior systemic antitumor therapy for recurrent or metastatic disease
- Prior adjuvant or neoadjuvant therapy allowed if completed at least 6 months ago without recurrence
- At least one measurable lesion per RECIST v1.1
- Fulfillment of cachexia or pre-cachexia criteria by Fearon standards
- Age between 18 and 75 years
- ECOG performance status of 0 to 2
- Expected survival longer than 4 months
- Adequate organ function including hematologic, hepatic, coagulation, renal, and cardiac function
- Women of childbearing potential must have negative pregnancy test and agree to contraception
- Male patients must agree to contraception during and after study period
You will not qualify if you...
- Active or untreated central nervous system metastases
- Uncontrolled tumor-related pain
- History of thromboembolic disease, ascites, or leg edema within 6 months
- Other malignancies within 5 years except certain low-risk cancers
- Unresolved toxicity from prior anticancer therapy (except alopecia)
- Peritoneal metastases
- Pregnant or breastfeeding women
- Positive or uncontrolled hepatitis B or C infection
- Positive HIV test
- Major surgery within 28 days before randomization or planned during study
- Significant cardiovascular disease or unstable heart conditions
- Severe infection within 4 weeks before dosing or active infection requiring treatment within 2 weeks
- Conditions affecting gastrointestinal absorption or feeding difficulties
- Use of other appetite or weight-increasing medications
- Cushing's syndrome, adrenal or pituitary insufficiency, poorly controlled diabetes or hypertension
- History of severe gastrointestinal conditions within 6 months
- Known allergy to study drug components
- Any other condition making participation unsuitable per investigator judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Jinan, Shandong 0531
Jinan, China
Actively Recruiting
Research Team
J
Jinbo Yue, Dorcter
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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