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

NCT07550205 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: 25Y12800600
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ovarian Neoplasms Malignant; Chinese Herbal Medicine; Cognitive Behavioral Therapy; Medicine, Chinese Traditional; Sleep Initiation and Maintenance Disorders

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline, Week 18

• 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.

  From randomization, assessed continuously up to 2 years

Secondary Outcomes (8)

• 1-Year Progression-Free Survival Rate

  1 year after randomization

• 2-Year Progression-Free Survival Rate

  2 years after randomization

• Time to First Subsequent Therapy

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

• Chemotherapy Completion Rate

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

• Change in Patient Health Questionnaire-9 Score

  Baseline, Weeks 3, 6, 9, 12, 15, 18, 22, 26

Other Outcomes (2)

• Analysis of Predictive Biomarkers

  Baseline, Week 18

• Performance of AI Efficacy Prediction Model

  Up to 30 months.

Study Arms (4)

Tiaoshen Granules + CBT-I Group

EXPERIMENTAL

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

Placebo + CBT-I Grou

PLACEBO COMPARATOR

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

Tiaoshen Granules + Daoyin Group

EXPERIMENTAL

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

Tiaoshen Granules Only Group

ACTIVE COMPARATOR

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

Interventions

Tiaoshen Anti-cancer Granules DRUG

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.

Tiaoshen Granules + CBT-I Group; Tiaoshen Granules + Daoyin Group; Tiaoshen Granules Only Group

Placebo Granules DRUG

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.

Placebo + CBT-I Grou

Cognitive Behavioral Therapy for Insomnia BEHAVIORAL

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.

Placebo + CBT-I Grou; Tiaoshen Granules + CBT-I Group

Standard First-line Platinum-based Chemotherapy OTHER

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.

Placebo + CBT-I Grou; Tiaoshen Granules + CBT-I Group

Sleep-Regulating Daoyin Exercises BEHAVIORAL

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.

Tiaoshen Granules + Daoyin Group

Standard Maintenance Therapy OTHER

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.

Tiaoshen Granules + Daoyin Group; Tiaoshen Granules Only Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Meeting the diagnostic criteria for ovarian cancer-related insomnia (difficulty initiating sleep, sleep maintenance disturbance \[nocturnal awakening ≥2 times\], early morning awakening with inability to return to sleep, occurring ≥3 times per week and lasting ≥1 month).
• Possess the ability to comprehend assessment scales and undergo Cognitive Behavioral Therapy for Insomnia (e.g., Mini-Mental State Examination score ≥24, or education level above primary school).
• Voluntarily sign the informed consent form, agree to receive the study treatment, and able to independently complete a sleep diary.

You may not qualify if:

• 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.
• Language barriers that would prevent completion of assessments or therapy.
• Comorbid autoimmune diseases, congenital or acquired immunodeficiency diseases, hematological diseases, or long-term use of corticosteroids or immunosuppressants.
• Active hepatitis B, active tuberculosis, or other severe or uncontrolled infectious diseases.
• History of chronic alcohol dependence.
• Concurrent other primary malignant tumors (except for cured non-melanoma skin cancer, carcinoma in situ of the cervix, etc.).
• Participation in any other clinical trial within 3 months prior to enrollment.
• Legally incompetent, or any medical or ethical reason that may hinder the continuation of the study.

Sponsors & Collaborators

• Shanghai Municipal Hospital of Traditional Chinese Medicine: lead
• Obstetrics & Gynecology Hospital of Fudan University: collaborator
• Fudan University: collaborator
• Shanghai Mental Health Center: collaborator
• The First Affiliated Hospital of Naval Medical University: collaborator

Study Sites (1)

Shanghai Hospital of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, 200071, China

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Ovarian Neoplasms

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Jianhui Tian

  Shanghai Hospital of Traditional Chinese Medicine

  STUDY CHAIR

Central Study Contacts

Jianhui Tian, M.D.

CONTACT

86+18917763382; tjhhawk@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2026
• First Posted: April 24, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): September 30, 2029
• Study Completion (Estimated): September 30, 2029
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)