JMIR Publications

ABSTRACT

Background:

Symptom clusters are closely related to the decline in patients’ quality of life, increased risk of treatment interruption and poor prognosis. Among patients with ovarian cancer, the manifestation of psychoneurological symptom clusters are particularly prominent, seriously affecting their quality of life and prognosis of the disease. Efficient intervention measures are urgently needed. However, there is still a lack of specific treatment methods for the psychoneurological symptom clusters of ovarian cancer at present. Traditional Chinese medicine shows great potential in improving tumor-related symptom clusters and has unique advantages in overall regulation and comprehensive intervention.

Objective:

The primary objective of this study is to evaluate the efficacy and safety of the TSZA regimen in alleviating mental and psychological symptoms among ovarian cancer patients. Secondary objectives include assessing its impact on patients’ quality of life and survival outcomes. Furthermore, the study aims to explore the characteristics of the patient population that derives benefit from the TSZA regimen for these symptoms.

Methods:

A total of 316 ovarian cancer patients aged 18 to 70 with psychoneurological symptom cluster will be included and randomly divided into two parallel groups. Both groups will receive standard treatment for ovarian cancer as the basic treatment. The experimental 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 placebo combined with psychological intervention. The primary outcome measure is the psychoneurological symptom cluster score. Secondary outcome measures included the Pittsburgh Sleep Quality Index (PSQI), the Patient Health Questionnaire -9 (PHQ-9), the Generalized Anxiety Disorder -7 (GAD-7) scale, the revised Piper Fatigue Scale, the EORTC QLQ-C30 Quality of Life Scale, the TCM Syndrome Scale, and the 1-year survival analysis. In addition, this study also set a series of exploratory indicators (including sleep diary, functional magnetic resonance imaging, biomarkers of peripheral blood and tumor tissue, proportion of immune cells, cytokine levels, HPA axis function and immune gene expression analysis) and safety indicators (including vital signs, liver and kidney function and electrocardiogram). The study will be evaluated based on different indicators during the treatment period (baseline and the 1st, 2nd, and 3rd months of enrollment) and the follow-up period (the 6th, 9th, and 12th months of enrollment). Data analysis will be conducted using SPSS 26 software. A p value <0.05 is 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 November 2025. 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 psychoneurological symptom clusters in ovarian cancer patients, and generate clinical evidence for a new therapeutic option that improves quality of life and alleviates the symptom burden. Clinical Trial: ClinicalTrials.gov NCT07050563; https://clinicaltrials.gov/study/NCT07050563