Study Title: A Multicenter, Randomized Controlled Trial of Tiaoshen Anti-cancer Protocol Combined with Cognitive Behavioral Therapy for Insomnia in Improving Sleep and Survival in Ovarian Cancer Patients Purpose: This study aims to evaluate whether a combined therapy of traditional Chinese medicine (TCM) and modern psychotherapy can improve sleep and potentially extend survival for patients with ovarian cancer. Many patients experience severe, cancer-related insomnia, which lowers quality of life and may affect treatment outcomes.
Intervention \& Design: This is a randomized, double-blind, placebo-controlled trial conducted across multiple hospitals. Approximately 360 eligible patients with advanced ovarian cancer and significant insomnia will be enrolled.
Participants will be randomly assigned to one of two groups for the initial 18-week phase:
Experimental Group: Receives the Tiaoshen Anti-cancer herbal formula granules plus standard Cognitive Behavioral Therapy for Insomnia (CBT-I).
Control Group: Receives inactive placebo granules plus the same standard CBT-I. Neither the participants nor their treating doctors will know which granules are assigned during this phase. The primary goal is to compare the improvement in sleep quality between the two groups. Key secondary goals include assessing the therapy's impact on patients' anxiety, depression, overall quality of life, and the length of time before the cancer progresses (progression-free survival). All patients will receive standard-of-care chemotherapy.
Patients aged 18 to 80 years (inclusive).
Performance status (PS) score of 0-2.
Histologically or cytologically confirmed primary epithelial ovarian carcinoma, with postoperative FIGO stage III-IV, and scheduled to receive postoperative standard first-line platinum-based chemotherapy.
Having undergone ovarian cancer debulking surgery, in a stable condition at enrollment (no active infection, no severe hepatic or renal impairment, etc.), and planned for postoperative first-line platinum-based chemotherapy.
Previous systematic treatment with Cognitive Behavioral Therapy for Insomnia.
History of chronic insomnia, depression, or other psychiatric disorders prior to ovarian cancer diagnosis, AND with a Patient Health Questionnaire-9 score ≥15 and a Generalized Anxiety Disorder-7 score ≥15, AND long-term use of hypnotic or psychotropic medications.
Pregnant or lactating women.
Comorbid severe primary diseases of the cardiovascular, cerebrovascular, pulmonary, hepatic, renal, or hematopoietic systems.
Parallel
Tiaoshen Anti-cancer Granules
DrugThis intervention is a patented herbal formula granule (Patent No.: ZL202210718678.8) for cancer-related insomnia. Based on the "Mind-Regulating and Anti-Cancer" theory of Traditional Chinese Medicine (TCM), it is composed of four herbs: Astragalus Membranaceus (30g), Paris Polyphylla (9g), Spina Date Seed (30g), and Curcuma Aromatic (9g). The granules are manufactured by Jiangyin Tianjiang Pharmaceutical Co., Ltd. using modern standardized processes (including dynamic counter-current extraction, membrane separation, and spray drying) with a full-chain quality control system (including fingerprint chromatography) to ensure inter-batch consistency, stability, and safety. For the trial, both the active granules and a matched placebo (simulant containing only 5% of the active ingredient) are produced to be identical in appearance, smell, and packaging for the double-blind, placebo-controlled first phase.
Placebo Granules
DrugThis control intervention is a matched simulator (placebo) for the active "Tiaoshen Anti-cancer Granules." To ensure the rigor of the double-blind design, the placebo granules are identical to the active drug granules in appearance (color, shape), properties, smell, packaging specifications, and administration method. The key distinction is that the placebo contains less than 5% of the active drug ingredients (or lacks the main active components). It is manufactured by the same company (Jiangyin Tianjiang Pharmaceutical Co., Ltd.) using the same excipients and packaging processes to guarantee sensory indistinguishability, thereby enabling an objective evaluation of the true efficacy of the active drug.
Cognitive Behavioral Therapy for Insomnia
BehavioralThis intervention is a standardized, structured psychobehavioral therapy protocol designed according to international guidelines for cancer-related insomnia. It is not general psychological counseling but a systematically adapted protocol specifically targeting factors maintaining insomnia in cancer patients (e.g., somatic hyperarousal, cancer-related dysfunctional sleep beliefs, interference from treatment side effects). Core modules include: Sleep Restriction/Compression Therapy, Stimulus Control Therapy, Cognitive Restructuring (challenging catastrophizing thoughts such as "insomnia will inevitably cause cancer recurrence"), sleep hygiene education tailored for cancer patients, and relaxation training. It is delivered by certified therapists who have undergone protocol-specific training and receive regular supervision to ensure fidelity.
Standard First-line Platinum-based Chemotherapy
Other interventionThis intervention refers to the established standard first-line systemic chemotherapy regimen for postoperative patients with FIGO stage III-IV epithelial ovarian cancer, as per contemporary international authoritative clinical guidelines (e.g., CSCO, NCCN). It is not an investigational intervention of this study but the foundational anti-cancer treatment required for all enrolled patients. Specific regimens may include Paclitaxel plus Carboplatin, Nab-paclitaxel plus Carboplatin, or Docetaxel plus Carboplatin, among others. The specific drug choice and dosage are determined by the treating oncologist according to guidelines and individual patient conditions, independent of the study group assignment.
Sleep-Regulating Daoyin Exercises
BehavioralThis intervention is a standardized Traditional Chinese Medicine (TCM) Daoyin rehabilitation exercise derived from the national intangible cultural heritage, "Guben Yijin Jing Twelve Postures Daoyin Method." It is not general physical exercise or calisthenics but a seated mind-body regulation technique designed based on TCM theory for insomnia attributed to "disconnection between the heart and mind." The standardized procedure involves a series of gentle movements performed in a specific sitting posture, including pushing the arms forward and upward, leaning forward to massage the feet, and rubbing the hands to warm the kidney area, with an emphasis on the coordination of movement, breath, and mental focus. Practice is instructed by qualified Daoyin lecturers trained uniformly for the project, with adherence and accuracy ensured through instructional videos and practice logging.
Standard Maintenance Therapy
Other interventionThis intervention refers to the established standard maintenance therapy administered after completing first-line platinum-based chemotherapy, based on the patient's genetic test results (e.g., BRCA mutation, HRD status) and recommendations from clinical guidelines (e.g., CSCO, NCCN). It is not an investigational intervention of this study but the conventional anti-cancer treatment that patients in the second phase receive concurrently with the study-specific interventions (Daoyin exercises or Chinese medicine alone). Specific regimens typically involve oral PARP inhibitors (e.g., Olaparib, Niraparib) or Bevacizumab. The specific drug choice and dosage are independently determined by the treating oncologist according to guidelines and the patient's profile.
PSQI Response Rate
The proportion of subjects with a reduction of ≥ 50% in the total Pittsburgh Sleep Quality Index score from baseline. PSQI is a standardized scale assessing sleep quality, with higher scores indicating poorer sleep quality.
Progression-Free Survival
The time from randomization until the first observation of disease progression (according to RECIST 1.1 criteria) or death from any cause, whichever occurs first.
1-Year Progression-Free Survival Rate
The proportion of subjects alive and free from disease progression at 1 year after randomization.
2-Year Progression-Free Survival Rate
The proportion of subjects alive and free from disease progression at 2 years after randomization.
Time to First Subsequent Therapy
The time from the permanent discontinuation of the current (first-line) therapy to the initiation date of the next anti-cancer therapy.
Chemotherapy Completion Rate
The proportion of subjects who complete ≥ 75% of the planned (6-8 cycles) first-line platinum-based chemotherapy cycles.
Analysis of Predictive Biomarkers
Exploration of biomarkers associated with response to the "Tiaoshen" protocol (e.g., immune cell subsets, metabolites, HPA-axis related hormones) using multi-omics technologies (e.g., single-cell sequencing, metabolomics) on blood and (if accessible) tissue samples collected pre- and post-treatment.
Performance of AI Efficacy Prediction Model
Evaluate the accuracy (e.g., Area Under the Curve) of an artificial intelligence prediction model built on clinical multimodal data (demographics, lab tests, scale scores, etc.) in predicting patient PSQI response rate and progression-free survival.
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Shanghai Municipal Hospital of Traditional Chinese Medicine
Lead sponsor
Obstetrics & Gynecology Hospital of Fudan University
Collaborator
Fudan University
Collaborator
Shanghai Mental Health Center
Collaborator
The First Affiliated Hospital of Naval Medical University
Collaborator
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