Tumor-related Insomnia
Conditions
Interventions
Naturally Exposed Group: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.
Sponsors
Shanghai Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index (PSQI); | — |
Secondary
| Measure | Time frame |
|---|---|
| Insomnia Severity Index (ISI);European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30);Individual Components of the Pittsburgh Sleep Quality Index (PSQI); | — |
Countries
China
Contacts
Public ContactTIAN Jianhui
Shanghai Hospital of Traditional Chinese Medicine
Outcome results
None listed