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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-85
SponsorChangchun GeneScience Pharmaceutical Co., Ltd.

About this trial

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 criteria

Qualifiers

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).

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Nanocrystalline Megestrol Acetate

Treatment groups

495 Participants
are divided into 1 treatment group

Sponsors and collaborators