A Prospective Multi-Center Real-World Study of Ciwujia Capsules in the Treatment of Cancer-Related Insomnia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 3,000
- 主要终点
- Pittsburgh Sleep Quality Index (PSQI)
研究概览
简要总结
Cancer poses a severe threat to human physical and mental health as well as survival. High diagnostic rates of cancer and various treatments can significantly impact patients' sleep quality, leading to diverse sleep disorders. Cancer-related insomnia (CRI) is a prevalent sleep disturbance among cancer patients, potentially associated with the tumor itself, treatment modalities (such as surgery, chemotherapy, radiotherapy), psychological status, pain, fatigue, and other symptoms. Although reported incidence rates vary across studies, CRI is consistently high and severely compromises patients' quality of life. Core symptoms include difficulty falling asleep, sleep maintenance difficulties, and early morning awakening, which contribute to daytime fatigue, impaired concentration and memory, ultimately detrimentally affecting patients' health and quality of life. The pathogenesis of CRI is complex, potentially involving multiple factors including the tumor's direct effects, treatment side effects, psychological distress, pain, and fatigue.
The primary component of Ciwujia capsules (containing Eleutherococcus senticosus extract) is Ciwujia extract. To clarify the clinical efficacy of Ciwujia capsules for cancer-related insomnia in real-world clinical settings, this study will employ a multicenter, prospective, open-label, real-world research design. It is projected to involve 30-50 centers over an approximate 3-year trial period, with a planned enrollment of 3,000 subjects. Changes in sleep-related indicators before and after treatment will serve as the primary endpoint observation metrics. The study aims to investigate the clinical efficacy and safety profile of Ciwujia capsules in treating insomnia disorders in cancer patients, thereby providing robust evidence for identifying effective Chinese herbal medicine therapies for sedation and sleep promotion.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 and ≤75 years.
- •Histologically and/or cytologically confirmed diagnosis of malignancy. 3.Meet the diagnostic criteria for insomnia disorder per the Chinese Guidelines for Diagnosis and Treatment of Insomnia in Adults (2023) with one of the following conditions: 1）Directly cancer-related insomnia: Insomnia symptoms (e.g. difficulty falling asleep sleep maintenance difficulties early awakening) directly attributable to cancer-associated factors: ① Tumor-related factors: Pain cachexia dyspnea cough pruritus tumor compression symptoms etc. ② Cancer treatment-related factors: Chemotherapy-induced nausea/vomiting post-radiation mucositis surgical trauma etc. ③ Cancer-associated complications: Anemia infections metabolic disturbances etc. 2）Indirectly cancer-related insomnia: Insomnia directly caused by psychological stress reactions to cancer diagnosis or disease progression such as fear/anxiety about disease progression concerns about treatment side effects financial burden or psychosocial factors (e.g. insufficient family support).
- •4.Eastern Cooperative Oncology Group (ECOG) performance status score of 0-
- •5.Voluntarily participate and provide written informed consent.
排除标准
- •History of allergy to any component of the investigational product.
- •Liver dysfunction with ALT/AST levels exceeding 1.5 times the upper limit of normal (ULN).
- •Severe psychiatric disorders or emotional disturbances within the past year (e.g. anxiety depression suicidal tendencies or suicide attempts) requiring long-term use of CNS depressants or stimulants.
- •Women who are pregnant breastfeeding or of childbearing potential unwilling to use effective contraception during the study.
- •Insomnia secondary to uncontrolled severe cancer-related pain. 6.Participation in another clinical drug trial within the past month.
研究组 & 干预措施
Naturally Exposed Group
Patients voluntarily taking Ciwujia capsules, Ciwujia capsules for oral use，2-3 capsules per dose, three times daily. 28 days constitute one treatment course; efficacy and safety will be assessed over two courses. Dosage adjustments should follow the physician's instructions.
干预措施: Ciwujia capsules (Drug)
结局指标
主要结局
Pittsburgh Sleep Quality Index (PSQI)
时间窗: Assessments at baseline，day28±5，day56±5
次要结局
- EORTC QLQ-C30(Assessments at baseline，day14±3，day28±5，day56±5)
- Individual Components of the Pittsburgh Sleep Quality Index (PSQI)(Assessments at baseline，day28±5，day56±5)
- Insomnia Severity Index (ISI)(Assessments at baseline，day14±3，day28±5，day56±5)