Recruiting NCT07243379
A Prospective Real-World Observational Study of Nanocrystalline Megestrol Acetate in Patients With Cancer Cachexia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Nanocrystalline Megestrol Acetate.
- Who it may be relevant to
- Registry conditions: Clinical Characteristics and Treatment Outcomes of Malignant Tumor Cachexia, Multicenter Observational Study. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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.
Primary outcome measures
- Proportion of patients with improved appetite at Week 4 based on the A/CS-12 scale. [Time frame: Week 4]
Secondary outcome measures (1)
- 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.]
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 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Henan Cancer Hospital, Affiliated to Zhengzhou University — Zhengzhou
Identifiers
NCT: NCT07243379 · Megaxia-RWS 01