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RecruitingPhase 4NCT07243379

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

Sponsor

Changchun GeneScience Pharmaceutical Co., Ltd.

Enrollment

495 participants

Start Date

Sep 25, 2025

Study Type

INTERVENTIONAL

Conditions

Clinical Characteristics and Treatment Outcomes of Malignant Tumor CachexiaMulticenter Observational 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

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria5

  • 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 Criteria5

  • 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.

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Interventions

DRUGNanocrystalline 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.

Locations(1)

Henan Cancer Hospital, Affiliated to Zhengzhou University

Zhengzhou, Henan, China

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NCT07243379