A Prospective Multi-Center Real-World Study of Ciwujia Capsules in the Treatment of Cancer-Related Insomnia

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational [Patient Registry]
Eligible Ages	18 Years - 75 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Age ≥18 and ≤75 years. 2. 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 0-3. 5.Voluntarily participate and provide written informed consent.

Exclusion Criteria:

1. History of allergy to any component of the investigational product. 2. Liver dysfunction with ALT/AST levels exceeding 1.5 times the upper limit of normal (ULN). 3. 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. 4. Women who are pregnant breastfeeding or of childbearing potential unwilling to use effective contraception during the study. 5. Insomnia secondary to uncontrolled severe cancer-related pain. 6.Participation in another clinical drug trial within the past month.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT07050121
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Shanghai Municipal Hospital of Traditional Chinese Medicine
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Jianhui Tian, Doctor
Principal Investigator Affiliation	Shanghai Municipal Hospital of Traditional Chinese Medicine - Oncology Research Center
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Cancer, Insomnia, Cancer Related Insomnia

Arms & Interventions

Arms

: 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.

Interventions

Drug: - 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.

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Ze Liu, Master

[email protected]

86-13069967983

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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