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

November 19, 2025 updated by: Changchun GeneScience Pharmaceutical Co., Ltd.
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

495

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Henan
      • Zhengzhou, Henan, China, 45000
        • Recruiting
        • Henan Cancer Hospital, Affiliated to Zhengzhou University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nanocrystalline Megestrol Acetate Oral Suspension + Standard Antitumor Therapy
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients with improved appetite at Week 4 based on the A/CS-12 scale.
Time Frame: Week 4
Week 4

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients with >5% increase in body weight from baseline at Week 4, Week 8, and Week 12.
Time Frame: Proportion of patients with >5% increase in body weight from baseline to week 12.
Proportion of patients with >5% increase in body weight from baseline to week 12.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changchun GeneScience Pharmaceutical Co., Ltd.

Collaborators

Henan Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 25, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

November 15, 2025

First Submitted That Met QC Criteria

November 19, 2025

First Posted (Actual)

November 21, 2025

Study Record Updates

Last Update Posted (Actual)

November 21, 2025

Last Update Submitted That Met QC Criteria

November 19, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • Megaxia-RWS 01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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