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

Not Applicable

Recruiting

• Conditions: Clinical Characteristics and Treatment Outcomes of Malignant Tumor Cachexia; Multicenter Observational Study
• Interventions: Drug: Nanocrystalline Megestrol Acetate

• Registration Number: NCT07243379
• Lead Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-09-25
• Status Verified: 2025-10
• Study First Submitted: 2025-11-15
• Study First Submitted QC: 2025-11-19
• Last Update Submitted: 2025-11-19
• Study First Posted: 2025-11-21
• Last Update Posted: 2025-11-21
• Primary Completion: 2026-12-31
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 495

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nanocrystalline Megestrol Acetate Oral Suspension + Standard Antitumor Therapy	Nanocrystalline Megestrol Acetate	This cohort focuses on patients who have already been diagnosed with cachexia before the initiation of this study and are scheduled to receive treatment with nanocrystalline megestrol acetate.

Primary Outcome Measures

Name	Time	Method
Proportion of patients with improved appetite at Week 4 based on the A/CS-12 scale.	Week 4

Secondary Outcome Measures

Name	Time	Method
Proportion of patients with >5% increase in body weight from baseline at Week 4, Week 8, and Week 12.	Proportion of patients with >5% increase in body weight from baseline to week 12.

Trial Locations

Locations (1)

Henan Cancer Hospital, Affiliated to Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China