Henan Cancer Hospital, Affiliated to Zhengzhou University
Zhengzhou, Henan, 45000, China
Location status: Recruiting
Recruiting
NCT Number: NCT07243379
A Prospective Real-World Observational Study of Nanocrystalline Megestrol Acetate in Patients With Cancer Cachexia
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–85 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Nanocrystalline Megestrol Acetate
DrugNanocrystalline 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.
Primary outcomes
-
Proportion of patients with improved appetite at Week 4 based on the A/CS-12 scale.
Time frame: Week 4
Secondary outcomes
-
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.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Changchun GeneScience Pharmaceutical Co., Ltd.
Industry
Collaborators
- Henan Cancer Hospital
Registry information
Important dates
- Study start
- 2025
- Primary completion
- 2026
- Study completion
- 2027
- First posted
- Nov 21, 2025
- Registry last updated
- Nov 21, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.