Clinical Characteristics and Treatment Outcomes of Malignant Tumor Cachexia, Multicenter Observational Study
Conditions
Brief summary
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
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.
Sponsors
Henan Cancer Hospital
Changchun GeneScience Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with improved appetite at Week 4 based on the A/CS-12 scale. | Week 4 |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients with >5% increase in body weight from baseline at Week 4, Week 8, and Week 12. | Proportion of patients with >5% increase in body weight from baseline to week 12. |
Countries
China
Contacts
Primary ContactSuxia Luo
Outcome results
None listed