Nanocrystalline megestrol acetate for cancer-related cachexia in routine care
A Prospective Real-World Observational Study of Nanocrystalline Megestrol Acetate in Patients With Cancer Cachexia
This project tries nanocrystalline megestrol acetate to help adults with cancer-related cachexia who are starting this treatment in routine care.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 495 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Changchun GeneScience Pharmaceutical Co., Ltd. Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Zhengzhou, Henan) |
| Trial ID | NCT07243379 on ClinicalTrials.gov |
What this trial studies
This prospective, real-world, multicenter observational Phase 4 study follows adults with cancer-related cachexia who are prescribed nanocrystalline megestrol acetate in routine practice. Eligible patients meet Fearon cachexia criteria, have histologically confirmed malignancy, ECOG 0–2, expected survival ≥3 months, and BMI ≤30. The study collects data on weight change, appetite, performance status, and adverse events while excluding patients with gastrointestinal absorption problems, AIDS, or concurrent appetite-stimulating medications. Data are captured during routine clinic visits at participating centers to reflect everyday clinical use and safety in a real-world population.
Who should consider this trial
Good fit: Adults (≥18) with histologically or cytologically confirmed cancer who meet Fearon cachexia criteria, have ECOG 0–2, expected survival ≥3 months, and BMI ≤30 are the intended participants.
Not a fit: Patients with conditions affecting gastrointestinal absorption, anorexia from psychiatric disorders, AIDS, those receiving other appetite stimulants, or with very short expected survival are unlikely to benefit from this treatment in the study context.
Why it matters
Potential benefit: If successful, this could provide a more easily absorbed, practical option to improve appetite and weight in patients with cancer cachexia treated in routine clinical settings.
How similar studies have performed: Standard megestrol acetate formulations have previously shown improvements in appetite and weight in cancer cachexia, but the nanocrystalline formulation has limited published real-world Phase 4 data.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Zhengzhou, Henan
- Henan Cancer Hospital, Affiliated to Zhengzhou University — Zhengzhou, Henan, China (Recruiting)
Study contacts
- Study coordinator: Suxia Luo
- Email: luosxrm@163.com
- Phone: 18638553211
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.