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

Phase 4RecruitingNCT07243379

Changchun GeneScience Pharmaceutical Co., Ltd.495 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

495

Conditions

Clinical Characteristics and Treatment Outcomes of Malignant Tumor Cachexia Multicenter Observational Study

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: Week 4

Secondary Outcomes

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

Time frame: Proportion of patients with >5% increase in body weight from baseline to week 12.