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Recruiting Phase 4

A Prospective Real-World Observational Study of Nanocrystalline Megestrol Acetate in Patients With Cancer Cachexia

NCT07243379 · tracked via the Priya Life Science China tracker
Phase
Phase 4
Started
2025-09-25
Last updated
2025-11-21

Condition(s) studied

Clinical Characteristics and Treatment Outcomes of Malignant Tumor CachexiaMulticenter Observational Study

Investigational drug(s) / intervention(s)

Nanocrystalline Megestrol Acetate →

Nanocrystalline Megestrol Acetate: Nanocrystalline Megestrol Acetate oral suspension, with a specification of 125 mg/mL, administered orally at a dose of 5 mL per day (625 mg/day), and the primary endpoint efficacy collection will be conducted in the 4th week.

Study summary

This study is a prospective, real-world observational study. The objective is to evaluate the effectiveness and safety of nanocrystalline megestrol acetate in patients with cancer cachexia in real-world settings. Eligible participants were patients diagnosed with cancer cachexia who were scheduled to receive treatment with nanocrystalline megestrol acetate.

Eligibility

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria: * Patients with histologically and/or cytologically confirmed malignancy. * Age ≥18 years at enrollment. * Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2 and an expected survival of ≥3 months. * Meeting the diagnostic criteria for cachexia (based on Fearon's criteria). * Body mass index (BMI) ≤30. Exclusion Criteria: * Presence of any condition affecting gastrointestinal absorption, such as dysphagia, malabsorption, or uncontrolled vomiting; patients receiving tube feeding or parenteral nutrition. * Presence of anorexia due to anorexia nervosa, psychiatric disorders, or pain that makes eating difficult. * Patients with acquired immunodeficiency syndrome (AIDS). * Currently receiving or planning to receive other medications that increase appetite or body weight, such as corticosteroids (except short-term dexamethasone during chemotherapy), androgens, progestins, thalidomide, olanzapine, anamorelin, or other appetite stimulants. * Patients with Cushing's syndrome, adrenal or pituitary insufficiency, or poorly controlled diabetes mellitus.

Primary outcome measure(s)

  • Proportion of patients with improved appetite at Week 4 based on the A/CS-12 scale. — Week 4

Trial sites (1)

FacilityCityRegionStatus
Henan Cancer Hospital, Affiliated to Zhengzhou University Zhengzhou Henan Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07243379 on ClinicalTrials.gov ↗ ← All trials in China