NCT07243379招募中4 期
A Prospective Real-World Observational Study of Nanocrystalline Megestrol Acetate in Patients With Cancer Cachexia
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 495
- 试验地点
- 1
- 主要终点
- Proportion of patients with improved appetite at Week 4 based on the A/CS-12 scale.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Nanocrystalline Megestrol Acetate Oral Suspension + Standard Antitumor Therapy
Experimental
This cohort focuses on patients who have already been diagnosed with cachexia before the initiation of this study and are scheduled to receive treatment with nanocrystalline megestrol acetate.
干预措施: Nanocrystalline Megestrol Acetate (Drug)
结局指标
主要结局
Proportion of patients with improved appetite at Week 4 based on the A/CS-12 scale.
时间窗: Week 4
次要结局
- 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.)
研究者
研究点 (1)
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