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

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

Recruiting
18-85 years
All
Phase 4

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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.

Eligibility

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

NCT07243379

Changchun GeneScience Pharmaceutical Co., Ltd.

31 January 2026

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