Evaluation of the TiaoShenZhiAi Regimen for Patients With Ovarian Cancer Experiencing a Psychoneurological Symptom Cluster: Protocol for a Multicenter, Double-Blind, Randomized Controlled Trial.
This record describes a planned 316-participant, multicenter, double-blind randomized trial comparing an herbal TSZA regimen plus psychological intervention with a low-dose active herbal control plus psychological intervention for psychoneurological symptoms in adults with ovarian cancer.
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This record describes a planned 316-participant, multicenter, double-blind randomized trial comparing an herbal TSZA regimen plus psychological intervention with a low-dose active herbal control plus psychological intervention for psychoneurological symptoms in adults with ovarian cancer.
Research significance
The protocol tests whether adding Compound Ciwujia Granules to psychological intervention and standard ovarian-cancer care can reduce psychoneurological symptom burden and improve quality of life; potential effects through neuroendocrine or immune pathways are exploratory hypotheses, not demonstrated mechanisms.
Source abstract
BACKGROUND: Psychoneurological symptom clusters (PNSCs) are common in patients with ovarian cancer and are associated with reduced quality of life, treatment interruption, and poor prognosis. However, effective interventions for PNSCs remain limited. Traditional Chinese medicine may provide comprehensive benefits for symptom management. OBJECTIVE: This study aims to evaluate the efficacy and safety of the TiaoShenZhiAi (TSZA) regimen in alleviating PNSCs in patients with ovarian cancer and to assess its effects on quality of life and survival outcomes. METHODS: A total of 316 patients with ovarian cancer aged 18 to 70 years with PNSCs will be included and randomly divided into 2 parallel groups. Both groups will receive standard treatment for ovarian cancer as the basic treatment. The intervention group will receive the TSZA regimen, that is, Compound Ciwujia Granules (containing Acanthopanax senticosus and Schisandra chinensis) combined with psychological intervention. The control group will receive a low-dose active control (simulated Compound Ciwujia Granules) combined with psychological intervention. The primary outcome is the remission rate of PNSCs at 3 months. The secondary outcome measures include the Pittsburgh Sleep Quality Index, the Patient Health Questionnaire-9, the Generalized Anxiety Disorder-7 scale, the revised Piper Fatigue Scale, the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 Quality of Life Scale, the traditional Chinese medicine syndrome scale, sleep quality, sleep diary, and the 1-year survival analysis. In addition, this study also includes a series of exploratory indicators (including functional magnetic resonance imaging, biomarkers of peripheral blood and tumor tissue, proportion of immune cells, cytokine levels, hypothalamic-pituitary-adrenal axis function, and immune gene expression analysis) and safety indicators (including vital signs, liver and kidney function, and electrocardiogram). The study outcomes will be evaluated based on different indicators during the treatment period (baseline and the 1st, 2nd, and 3rd mo of enrollment) and the follow-up period (the 6th, 9th, and 12th mo of enrollment). Data analysis will be conducted using R (version 4.5.3) software. A one-sided P value of <.03 will be considered statistically significant. RESULTS: This study is designed to enroll a total of 316 participants. Participant enrollment is set to commence in October 2025, with no recruitment having occurred as of April 2026. The recruitment period will extend until September 2028 or until the target enrollment is met. Data analysis is scheduled for November 2028, with submission of the trial results to a peer-reviewed journal anticipated by May 2029. CONCLUSIONS: This study will evaluate the efficacy of the TSZA regimen in managing PNSCs in patients with ovarian cancer and generate clinical evidence for a new therapeutic option that improves quality of life and alleviates the symptom burden.