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

Not Applicable

Not yet recruiting

• Conditions: Cancer Symptom Clusters; Cancer
• Interventions: Drug: Compound Ciwujia Granules; Drug: Placebo granules; Combination Product: Standard treatment protocol for ovarian cancer combined with psychological intervention.

• Registration Number: NCT07050563
• Lead Sponsor: Shanghai Municipal Hospital of Traditional Chinese Medicine

Brief 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.

Detailed Description

Targeting ovarian cancer patients with psychoneurological symptom clusters, a multicenter, randomized, placebo-controlled, superiority clinical trial was conducted. On the basis of psychological intervention and conventional cancer treatment, the treatment group and the control group respectively received Compound Ciwujia Granules or a placebo. The intervention lasted for three months, with the alleviation of psychoneurological symptoms assessed before and after treatment in both groups.

The primary efficacy endpoint was the mean score of the subscale comprising sleep disturbance, fatigue, distress, and sadness from the Chinese version of the MD Anderson Symptom Inventory for Ovarian Cancer (MDASI-OC). Secondary efficacy endpoints included the EORTC QLQ-C30 quality of life scale, sleep quality assessment, and sleep diaries. Exploratory endpoints included the 1-year overall survival (OS) rate and progression-free survival (PFS) rate. Peripheral blood samples and tumor tissue specimens were collected to investigate common biological targets underlying the psychoneurological symptom cluster in ovarian cancer.

Study Timeline

• Study First Submitted: 2025-06-11
• Study First Submitted QC: 2025-06-25
• Status Verified: 2025-07
• Study First Posted: 2025-07-03
• Last Update Submitted: 2025-07-28
• Last Update Posted: 2025-07-29
• Study Start: 2025-08-06
• Primary Completion: 2028-09-01
• Study Completion: 2028-11-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 316

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Compound Ciwujia Granules	Daily Compound Ciwujia granules+ standard treatment protocol for ovarian cancer+ psychological intervention
Intervention Group	Standard treatment protocol for ovarian cancer combined with psychological intervention.	Daily Compound Ciwujia granules+ standard treatment protocol for ovarian cancer+ psychological intervention
Control group	Placebo granules	Daily placebo granules + standard treatment protocol for ovarian cancer+ psychological intervention
Control group	Standard treatment protocol for ovarian cancer combined with psychological intervention.	Daily placebo granules + standard treatment protocol for ovarian cancer+ psychological intervention

Primary Outcome Measures

Name	Time	Method
Psychoneurological Symptom Cluster in Ovarian Cancer	Assessed at baseline and 3 months post-enrollment	Mean score of the subscale composed of sleep disturbance, fatigue, distress, and sadness in the MD Anderson Symptom Inventory for ovarian cancer (MDASI-OC)

Secondary Outcome Measures

Name	Time	Method
1-year survival analysis	Determined at the 1-year follow-up after random assignment	From randomization, patients underwent regular imaging assessments to determine 1-year overall survival (OS) and progression-free survival (PFS) rates.
Piper Fatigue Scale	Assessments at baseline and at 1, 2, and 3 months post-enrollment
Pittsburgh Sleep Quality Index (PSQI) Sleep Scale	Assessments at baseline and at 1, 2, and 3 months post-enrollment
Patient Health Questionnaire-9 (PHQ-9) Depression Scale	Assessments at baseline and at 1, 2, and 3 months post-enrollment
Chinese Traditional Medicine Syndrome Pattern Assessment Scale	Assessments at baseline and at 1, 2, and 3 months post-enrollment
EORTC QOL-C30 Scale	Assessments at baseline and at 1, 2, and 3 months post-enrollment	Quality of Life Questionnaire-Core 30