Tiaoshen Anti-cancer Protocol and CBT for Insomnia and Survival in Ovarian Cancer

Browse trials for

• Sleep Initiation and Maintenance Disorders 1,855
• Ovarian Neoplasms 2,695

Keywords

• Ovarian Cancer
• Cancer-Related Insomnia
• Traditional Chinese Medicine
• Cognitive Behavioral Therapy for Insomnia
• Randomized Controlled Trial
• Progression-Free Survival

Sleep Initiation and Maintenance Disorders

1,855 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 593 are open to participants now.

This study's planned enrollment of 360 is above the median of 73 across 1,631 interventional studies indexed under Sleep Initiation and Maintenance Disorders.

Lead sponsor

Shanghai Municipal Hospital of Traditional Chinese Medicine is the lead sponsor of 14 studies on the registry; 9 are open to participants now.

Study arms

• Experimental
  Tiaoshen Granules + CBT-I Group

  Drug: Tiaoshen Anti-cancer Granules · Behavioral: Cognitive Behavioral Therapy for Insomnia · Other: Standard First-line Platinum-based Chemotherapy

• Placebo comparator
  Placebo + CBT-I Grou

  Drug: Placebo Granules · Behavioral: Cognitive Behavioral Therapy for Insomnia · Other: Standard First-line Platinum-based Chemotherapy

• Experimental
  Tiaoshen Granules + Daoyin Group

  Drug: Tiaoshen Anti-cancer Granules · Behavioral: Sleep-Regulating Daoyin Exercises · Other: Standard Maintenance Therapy

• Active comparator
  Tiaoshen Granules Only Group

  Drug: Tiaoshen Anti-cancer Granules · Other: Standard Maintenance Therapy

Interventions

• DrugTiaoshen Anti-cancer Granules

  This 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.

• DrugPlacebo Granules

  This 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.

• BehavioralCognitive Behavioral Therapy for Insomnia

  This 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.

• OtherStandard First-line Platinum-based Chemotherapy

  This 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.

• BehavioralSleep-Regulating Daoyin Exercises

  This 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.

• OtherStandard Maintenance Therapy

  This 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.

Primary outcomes

1. 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.

   Time frame: Baseline, Week 18

2. 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.

   Time frame: From randomization, assessed continuously up to 2 years

Secondary outcomes

1. 1-Year Progression-Free Survival Rate

   The proportion of subjects alive and free from disease progression at 1 year after randomization.

   Time frame: 1 year after randomization

2. 2-Year Progression-Free Survival Rate

   The proportion of subjects alive and free from disease progression at 2 years after randomization.

   Time frame: 2 years after randomization

3. 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.

   Time frame: From the end of first-line therapy, assessed until start of second-line therapy or death (up to 2 years)

4. Chemotherapy Completion Rate

   The proportion of subjects who complete ≥ 75% of the planned (6-8 cycles) first-line platinum-based chemotherapy cycles.

   Time frame: During the first-line chemotherapy phase (approximately within 18 weeks)

5. Change in Patient Health Questionnaire-9 Score

   A 9-item scale used to assess the severity of depressive symptoms. Total scores range from 0 to 27, with higher scores indicating greater severity of depression.

   Time frame: Baseline, Weeks 3, 6, 9, 12, 15, 18, 22, 26

6. Change in Generalized Anxiety Disorder-7 Score

   A 7-item scale used to assess the severity of anxiety symptoms. Total scores range from 0 to 21, with higher scores indicating greater severity of anxiety.

   Time frame: Baseline, Weeks 3, 6, 9, 12, 15, 18, 22, 26

7. Change in EORTC QLQ-C30 Score

   The EORTC QLQ-C30 is a core quality-of-life questionnaire developed by the European Organisation for Research and Treatment of Cancer. It consists of multiple subscales: global health status (range 0-100), functional domains (physical, role, emotional, cognitive, social; each range 0-100), and symptom domains (fatigue, nausea/vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea; each range 0-100). For the global health status and functional subscales, higher scores indicate better quality of life and functioning (better outcome). For the symptom subscales, higher scores indicate more severe symptoms (worse outcome). Each subscale will be analyzed separately as a continuous variable.

   Time frame: Baseline, Weeks 6, 12, 18, 22, 26

8. Change in TCM Syndrome Score

   The Traditional Chinese Medicine (TCM) Symptom Score is a scale developed according to the "Shanghai TCM Disease Diagnosis and Treatment Routine." It assesses 7 core symptoms (difficulty falling asleep, light sleep with easy awakening, dream-disturbed sleep and early awakening, fatigue and weakness, irritability, palpitations and forgetfulness, dry mouth and throat), each scored from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe). The total score ranges from 0 to 21. Higher scores indicate more severe TCM symptoms, representing worse outcomes.

   Time frame: Baseline, Weeks 6, 12, 18, 22, 26

Other outcomes

1. 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.

   Time frame: Baseline, Week 18

2. 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.

   Time frame: Up to 30 months.

Study documents

• Protocol and statistical analysis plan · Oct 31, 2025
• Informed consent form · Oct 31, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — IPD will not be shared outside the primary research team at this stage. The study involves a proprietary TCM formula (Mind-Regulating Cancer Treatment Protocol) and a unique integrative intervention. Premature data sharing could compromise pending patents and ongoing mechanistic studies. The dataset includes multimodal information (clinical scales, TCM syndrome evaluations, multi-omics, AI data). Accurate interpretation requires domain expertise; premature release risks misinterpretation. The ethics-approved informed consent did not include broad data sharing provisions. Therefore, IPD will not be publicly available. However, de-identified data supporting primary/secondary outcomes may be available upon reasonable request to the corresponding author after main results are published, subject to a formal data use agreement and ethics approval.