Nanocrystalline megestrol acetate for cancer-related cachexia in routine care

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Henan Cancer Hospital, Affiliated to Zhengzhou University
  Zhengzhou, Henan, China Recruiting

Study contacts

• Study coordinator: Suxia Luo
• Email: luosxrm@163.com
• Phone: 18638553211

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.