Clinical Evaluation of the Tiaoshen Anti-Cancer Regimen in Treating Psycho-Neurological Symptom Cluster in Ovarian Cancer

Launched by SHANGHAI MUNICIPAL HOSPITAL OF TRADITIONAL CHINESE MEDICINE · Jun 25, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a Traditional Chinese Medicine (TCM) treatment called the Tiaoshen Anti-Cancer Regimen to help women with ovarian cancer who are experiencing a group of symptoms that often occur together, including sleep problems, fatigue, and emotional distress like sadness or anxiety. These symptoms, known as a symptom cluster, can happen because of the cancer itself or the treatments for cancer. The study aims to see if this TCM approach can safely reduce these symptoms and improve quality of life for patients.

Women between 18 and 70 years old with confirmed ovarian cancer who have moderate to severe sleep difficulties, tiredness, and emotional distress may be eligible to join. Participants should also meet certain health and traditional medicine criteria and expect to live for more than a year. The trial will be carefully conducted with some women receiving the TCM treatment and others receiving a placebo, without anyone knowing which one they get, to fairly test the treatment’s effects. Those interested will need to agree to keep sleep diaries and follow the study procedures. This study has not started recruiting yet, but it hopes to find out who benefits most from this TCM treatment and help improve care for women facing these challenging symptoms.

Gender

FEMALE

Eligibility criteria

• 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)
• • Diabetes mellitus