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NCT Number: NCT07050121

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

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.

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Key information

Conditions

Cancer Cancer Related Insomnia Dyssomnias Insomnia Mental Disorders Neoplasms Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 0-3. 5.Voluntarily participate and provide written informed consent.

Exclusion criteria

  • 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.

Treatment and study plan

Ciwujia capsules

Drug

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.

Primary outcomes

  1. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Assessments at baseline，day28±5，day56±5

Secondary outcomes

  1. Individual Components of the Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Assessments at baseline，day28±5，day56±5

    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.

  2. Insomnia Severity Index (ISI)

    Time frame: Assessments at baseline，day14±3，day28±5，day56±5

  3. EORTC QLQ-C30

    Time frame: Assessments at baseline，day14±3，day28±5，day56±5

Other outcomes

  1. Pharmacoeconomic Evaluation

    Time frame: Assessments were performed after day 56 post-enrollment.

    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.

  2. Alanine Aminotransferase(ALT)

    Time frame: Assessments at baseline, day56±5

    Non-mandatory indicators, tested based on patient preference

  3. Urine Protein

    Time frame: Assessments at baseline, day56±5

    Non-mandatory indicators, tested based on patient preference

  4. White Blood Cell

    Time frame: Assessments at baseline, day56±5

    Non-mandatory indicators, tested based on patient preference

  5. Aspartate Aminotransferase(AST)

    Time frame: Assessments at baseline, day56±5

    Non-mandatory indicators, tested based on patient preference

  6. Serum Creatinine

    Time frame: Assessments at baseline, day56±5

    Non-mandatory indicators, tested based on patient preference

  7. Urine Occult Blood

    Time frame: Assessments at baseline, day56±5

    Non-mandatory indicators, tested based on patient preference

  8. Hemoglobin

    Time frame: Assessments at baseline, day56±5

    Non-mandatory indicators, tested based on patient preference

  9. Platelet

    Time frame: Assessments at baseline, day56±5

    Non-mandatory indicators, tested based on patient preference

  10. Electrocardiogram QT Interval

    Time frame: Assessments at baseline, day56±5

    Non-mandatory indicators, tested based on patient preference

Study contacts

Contact information is provided by the study sponsor or research team.

Jialiang Yao, Doctor

CONTACT

[email protected]

Ze Liu, Master

CONTACT

[email protected]

86-13069967983

Sponsors and collaborators

Lead sponsor

Shanghai Municipal Hospital of Traditional Chinese Medicine

Other

Collaborators

  • Bao'an Authentic TCM therapy Hospital
  • Chengdu Fifth People's Hospital
  • Chengdu Shuangliu Traditional Chinese Medicine Hospital
  • Ezhou Traditional Chinese Medicine Hospital
  • Fudan University
  • Guangdong Provincial Hospital of Traditional Chinese Medicine
  • Henan Provincial Hospital of Integrated Traditional Chinese and Western Medicine
  • Putuo District Central Hospital of Shanghai
  • Shaanxi Hospital of Traditional Chinese Medicine
  • Shanghai 7th People's Hospital
  • Shanghai East Hospital

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jul 3, 2025
Registry last updated
Jul 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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