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

NCT07243379 | Recruiting Phase 4

• 1 other identifier: Megaxia-RWS 01
• Study Type: interventional
• Target: 495
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with improved appetite at Week 4 based on the A/CS-12 scale.

  Week 4

Secondary Outcomes (1)

• Proportion of patients with >5% increase in body weight from baseline at Week 4, Week 8, and Week 12.

  Proportion of patients with >5% increase in body weight from baseline to week 12.

Study Arms (1)

Nanocrystalline Megestrol Acetate Oral Suspension + Standard Antitumor Therapy

EXPERIMENTAL

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.

Drug: Nanocrystalline Megestrol Acetate

Interventions

Nanocrystalline Megestrol Acetate DRUG

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.

Nanocrystalline Megestrol Acetate Oral Suspension + Standard Antitumor Therapy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Changchun GeneScience Pharmaceutical Co., Ltd.: lead
• Henan Cancer Hospital: collaborator

Study Sites (1)

Henan Cancer Hospital, Affiliated to Zhengzhou University

Zhengzhou, Henan, 45000, China

RECRUITING

Central Study Contacts

Suxia Luo

CONTACT

18638553211; luosxrm@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2025
• First Posted: November 21, 2025
• Study Start: September 25, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: November 21, 2025

Record last verified: 2025-10

Locations

CN (1)