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

RECRUITINGPhase 4Sponsored by Changchun GeneScience Pharmaceutical Co., Ltd.
Actively Recruiting
PhasePhase 4
SponsorChangchun GeneScience Pharmaceutical Co., Ltd.
Started2025-09-25
Est. completion2026-12-31
Eligibility
Age18 Years – 85 Years
Healthy vol.Accepted

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

Age: 18 Years – 85 YearsHealthy volunteers accepted
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.

Conditions3

CancerClinical Characteristics and Treatment Outcomes of Malignant Tumor CachexiaMulticenter Observational Study

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