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.
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).
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.
The purpose of this study is to evaluate the efficacy and safety of Ciwuja capsules in treating cancer-related insomnia in a real-world clinical setting. Cancer patients eligible for participation are not restricted by cancer type, disease stage, or treatment regimen, and may be enrolled after meeting the study's inclusion and exclusion criteria screening.
Other
Prospective
Ciwujia capsules
DrugCiwujia 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.
Pittsburgh Sleep Quality Index (PSQI)
Individual Components of the Pittsburgh Sleep Quality Index (PSQI)
Including sleep latency, subjective sleep quality, sleep continuity, habitual sleep efficiency, sleep disturbances, use of sleep medications, and daytime dysfunction. Each component will be assessed.
Insomnia Severity Index (ISI)
EORTC QLQ-C30
Pharmacoeconomic Evaluation
Conduct a pharmacoeconomic cost-effectiveness analysis, the unit cost of effectiveness is calculated by dividing the total drug-related expenses incurred during treatment - comprising direct costs (medication expenses) plus indirect costs (such as registration, transportation fees and so on) - by the change in PSQI scores before versus after drug administration.
Alanine Aminotransferase(ALT)
Non-mandatory indicators, tested based on patient preference
Urine Protein
Non-mandatory indicators, tested based on patient preference
White Blood Cell
Non-mandatory indicators, tested based on patient preference
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Shanghai Municipal Hospital of Traditional Chinese Medicine
Lead sponsor
Guangdong Provincial Hospital of Traditional Chinese Medicine
Collaborator
Henan Provincial Hospital of Integrated Traditional Chinese and Western Medicine
Collaborator
Shanghai East Hospital
Collaborator
Bao'an Authentic TCM therapy Hospital
Collaborator
Chengdu Fifth People's Hospital
Collaborator
Chengdu Shuangliu Traditional Chinese Medicine Hospital
Collaborator
Ezhou Traditional Chinese Medicine Hospital
Collaborator
Shanghai 7th People's Hospital
Collaborator
Shaanxi Hospital of Traditional Chinese Medicine
Collaborator
Putuo District Central Hospital of Shanghai
Collaborator
Fudan University
Collaborator
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