Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

NOT YET RECRUITING

NCT07050563

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

Sponsor: Shanghai Municipal Hospital of Traditional Chinese Medicine

View on ClinicalTrials.gov

Summary

The academic community generally believes that cancer symptom clusters (CSCs) are not independent diseases, but a group of symptoms that accompany cancer patients. Based on etiology, they can be classified into CSCs related to tumor progression, CSCs related to cancer treatment, or a combination of both. According to symptom manifestations, they can be divided into psychological symptom CSCs, somatic symptom CSCs, and CSCs with coexisting psychological and somatic symptoms. CSCs are universally present during the progression or treatment of cancer. Traditional Chinese medicine (TCM) can leverage its unique characteristics in the intervention of symptom clusters and symptom management. This study is planned to conduct a high-level, prospective, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of a TCM regimen for cancer symptom clusters (CSCs), and to simultaneously analyze the characteristics of the population that may benefit most from TCM treatment for CSCs.

Key Details

Gender

FEMALE

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

316

Start Date

2025-10-06

Completion Date

2028-11-30

Last Updated

2025-09-29

Healthy Volunteers

Conditions

Cancer Cancer Symptom Clusters

Interventions

DRUG

Compound Ciwujia Granules

In addition to standard treatment protocol for ovarian cancer combined with psychological intervention, Compound Ciwujia Granules were administered at a dosage of one sachet twice daily for a treatment duration of 3 months.

DRUG

Placebo granules

In addition to standard treatment protocol for ovarian cancer combined with psychological intervention, placebo granules which containing 10% of Compound Ciwujia Granules drug were administered at a dosage of one sachet twice daily for a treatment duration of 3 months.

COMBINATION_PRODUCT

Standard treatment protocol for ovarian cancer combined with psychological intervention.

Standard treatment protocol for ovarian cancer: In accordance with the 2024 NCCN International Guidelines, patients opt for chemotherapy regimens containing platinum-based drugs and/or targeted therapy, anti-angiogenic therapy, hormonal therapy, etc. Psychological intervention is conducted once a week in the form of online and offline patient education sessions for psychological intervention, continuing until the end of the study period. Both the intervention group and the control group use this as the baseline treatment plan.

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