Ancient medicine meets modern cancer care: can TCM ease ovarian cancer symptoms?

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Histologically or cytologically confirmed primary epithelial ovarian cancer * 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 * 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) * Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score 0-2; * Age 18-70 years * Meeting TCM diagnostic criteria for spleen-kidney yang deficiency syndrome; * Expected survival \>1 year * Signed informed consent form with voluntary acceptance of the treatment protocol and ability to independently complete sleep diaries Exclusion Criteria: * Patients scheduled to undergo radiotherapy within the next 4 treatment cycles * 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) * 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; * Scores ≥15 on the Patient Health Questionnaire (PHQ-9) for depression or ≥15 on the Generalized Anxiety Disorder-7 (GAD-7) at screening * Pre-existing chronic insomnia or depression diagnosed prior to ovarian cancer * Comorbid autoimmune diseases, hematologic disorders, or long-term use of corticosteroids/immunosuppressants * History of other primary malignancies * Participation in other clinical trials within 3 months * HIV-positive status, congenital/acquired immunodeficiency disorders, or history of organ transplantation (including autologous bone marrow or peripheral stem cell transplantation) * Legally incapacitated individuals, or cases with medical/ethical contraindications to study continuation * Active hepatitis B, active tuberculosis, or evidence of severe/uncontrolled systemic inflammatory conditions (e.g., unstable respiratory, cardiovascular, hepatic, or renal diseases) * Patients with diabetes