ovarian cancer
Conditions
Interventions
Intervention Group:In addition to standardized treatment combined with psychological intervention, Compound Ciwujia Granules were administered at a dosage of one sachet twice daily for a treatment dur
Control group:In addition to standardized treatment combined with psychological intervention, placebo granules were administered at a dosage of one sachet twice daily for a treatment duration of 3 mo
Sponsors
Shanghai Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Histologically or cytologically confirmed primary epithelial ovarian cancer; (2) Meet diagnostic criteria for chronic insomnia defined by the Sleep Disorders Group of the Neurology Branch of the Chinese Medical Association: Pittsburgh Sleep Quality Index (PSQI) total score >8 Piper Fatigue Scale total score >4 and Patient Health Questionnaire-9 (PHQ-9) total score >5; (3) Moderate-to-severe symptom severity (average score =4 on the MD Anderson Symptom Inventory for Ovarian Cancer [MDASI-OC] subscale assessing sleep disturbance-fatigue-distress-sadness); (4) Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score 0-2; (5) Age 18-70 years; (6) Meeting TCM diagnostic criteria for spleen-kidney yang deficiency syndrome; (7) Expected survival >1 year; (8) Signed informed consent form with voluntary acceptance of the treatment protocol and ability to independently complete sleep diaries.
Exclusion criteria
Exclusion criteria: (1) Patients scheduled to undergo radiotherapy within the next 4 treatment cycles; (2) Comorbid severe primary diseases of the heart, brain, liver, kidney, or hematopoietic system, including hepatic dysfunction (AST/ALT >1.5 times the upper limit of normal [ULN]) or renal impairment (serum creatinine [Cr] >1.2 times ULN); (3) Pregnant or lactating women, individuals with psychiatric disorders (e.g., schizophrenia, bipolar disorder, mania, depression, anxiety disorders, phobias), intellectual/language impairments, or other mental health conditions; (4) Scores =15 on the Patient Health Questionnaire (PHQ-9) for depression or =15 on the Generalized Anxiety Disorder-7 (GAD-7) at screening; (5) Pre-existing chronic insomnia or depression diagnosed prior to ovarian cancer; (6) Comorbid autoimmune diseases, hematologic disorders, or long-term use of corticosteroids/immunosuppressants; (7) History of other primary malignancies; (8) Participation in other clinical trials within 3 months; (9) HIV-positive status, congenital/acquired immunodeficiency disorders, or history of organ transplantation (including autologous bone marrow or peripheral stem cell transplantation); (10) Legally incapacitated individuals, or cases with medical/ethical contraindications to study continuation; (11) Active hepatitis B, active tuberculosis, or evidence of severe/uncontrolled systemic inflammatory conditions (e.g., unstable respiratory, cardiovascular, hepatic, or renal diseases); (12) Diabetes mellitus.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ovarian Cancer-Related Neuropsychiatric Symptom Clusters; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index (PSQI) Sleep Scale;Sleep quality;Sleep diary;Generalized Anxiety Disorder 7-item (GAD-7) Anxiety Scale;1-year survival analysis;Piper Fatigue Scale;Patient Health Questionnaire-9 (PHQ-9) Depression Scale;EORTC QOL-C30 Scale (Quality of Life Questionnaire-Core 30);TCM Syndrome Pattern Assessment Scale; | — |
Countries
China
Contacts
Public ContactJianhui Tian
Shanghai Hospital of Traditional Chinese Medicine
Outcome results
None listed