A Prospective Real-World Observational Study of Nanocrystalline Megestrol Acetate in Patients With Cancer Cachexia
Recruiting
Phase 4Interventional Study
Clinical Characteristics and Treatment Outcomes of Malignant Tumor CachexiaMulticenter Observational Study
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 85
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
495 (estimated)
Sponsor
Changchun GeneScience Pharmaceutical Co., Ltd. · Industry
Who this trial is looking for
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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.
Trial Locations
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Eligibility 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 Fe…
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.
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