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

GeneScience Pharmaceuticals (GenSci)

Status and phase: Enrolling; Phase 4

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

Treatments: Drug: Nanocrystalline Megestrol Acetate

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07243379

Megaxia-RWS 01

Details and patient eligibility

About

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.

Enrollment: 495 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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495 participants in 1 patient group

Nanocrystalline Megestrol Acetate Oral Suspension + Standard Antitumor Therapy

Experimental group

Description:

This cohort focuses on patients who have already been diagnosed with cachexia before the initiation of this study and are scheduled to receive treatment with nanocrystalline megestrol acetate.

Treatment:

Drug: Nanocrystalline Megestrol Acetate