Ovarian Neoplasms MalignantPhase 2/3NCT07550205
Tiaoshen Anti-cancer Protocol and CBT for Insomnia and Survival in Ovarian Cancer
A Phase 2/3 study testing Tiaoshen Anti-cancer Granules, Cognitive Behavioral Therapy for Insomnia and Standard First-line Platinum-based Chemotherapy in people with Ovarian Neoplasms Malignant and Sleep Initiation and Maintenance Disorders, run by Shanghai Municipal Hospital of Traditional Chinese Medicine at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Ovarian Neoplasms Malignant, Sleep Initiation and Maintenance Disorders, Medicine, Chinese Traditional
- What is being tested?
- Tiaoshen Anti-cancer Granules, Cognitive Behavioral Therapy for Insomnia and Standard First-line Platinum-based Chemotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 360 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2026to 30 Sep 2029
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai Hospital of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 200071
Jianhui Tian, 86+18917763382, tjhhawk@163.com
About this study
Official title: Tiaoshen Anti-cancer Protocol and CBT for Insomnia and Survival in Ovarian Cancer: A Multicenter Randomized Trial
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.
Read more
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.
Read the detailed description
This clinical trial investigates a novel integrative approach for managing cancer-related insomnia in advanced ovarian cancer. Targeting a prevalent yet under-addressed issue affecting over 60% of patients, the study evaluates the synergistic effect of combining the Tiaoshen Anti-cancer Protocol, a patented Traditional Chinese Medicine formula, with standard Cognitive Behavioral Therapy for Insomnia (CBT-I). In this multicenter, randomized, double-blind, placebo-controlled trial, approximately 360 patients with FIGO stage III-IV ovarian cancer and clinically significant insomnia will be randomized to receive either active Tiaoshen herbal granules or matched placebo for 18 weeks, with both groups concurrently receiving structured CBT-I. The co-primary endpoints are the improvement in sleep quality, measured by the Pittsburgh Sleep Quality Index response rate, and progression-free survival. Secondary objectives include assessing impacts on anxiety, depression, quality of life, and exploring predictive biomarkers. The study employs a two-stage adaptive design, where initial responders may be re-randomized to evaluate the added benefit of a mind-body exercise in a maintenance phase. This research aims to provide high-level evidence for a holistic strategy to break the "insomnia-progression" cycle, ultimately seeking to improve both quality of life and survival outcomes.
- Conditions
- Ovarian Neoplasms Malignant, Sleep Initiation and Maintenance Disorders, Medicine, Chinese Traditional, Chinese Herbal Medicine, Cognitive Behavioral Therapy
- Being tested
- Tiaoshen Anti-cancer Granules, Placebo Granules, Cognitive Behavioral Therapy for Insomnia, Standard First-line Platinum-based Chemotherapy, Sleep-Regulating Daoyin Exercises
- Keywords
- Ovarian Cancer, Cancer-Related Insomnia, Traditional Chinese Medicine, Cognitive Behavioral Therapy for Insomnia, Randomized Controlled Trial, Progression-Free Survival
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tiaoshen Anti-cancer GranulesDrug
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.
Placebo GranulesDrug
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.
Cognitive Behavioral Therapy for InsomniaBehavioural
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.
Standard First-line Platinum-based ChemotherapyOther
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.
Sleep-Regulating Daoyin ExercisesBehavioural
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.
Standard Maintenance TherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Tiaoshen Granules + CBT-I Group | Experimental | Not described Receives: Drug: Tiaoshen Anti-cancer Granules; Behavioral: Cognitive Behavioral Therapy for Insomnia; Other: Standard First-line Platinum-based Chemotherapy |
| Placebo + CBT-I Grou | Placebo comparator | Not described Receives: Drug: Placebo Granules; Behavioral: Cognitive Behavioral Therapy for Insomnia; Other: Standard First-line Platinum-based Chemotherapy |
| Tiaoshen Granules + Daoyin Group | Experimental | Not described Receives: Drug: Tiaoshen Anti-cancer Granules; Behavioral: Sleep-Regulating Daoyin Exercises; Other: Standard Maintenance Therapy |
| Tiaoshen Granules Only Group | Active comparator | Not described Receives: Drug: Tiaoshen Anti-cancer Granules; Other: Standard Maintenance Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From randomization, assessed continuously up to 2 years
Secondary outcomes (8)
1-Year Progression-Free Survival Rate
The proportion of subjects alive and free from disease progression at 1 year after randomization.
Measured: 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.
Measured: 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.
Measured: From the end of first-line therapy, assessed until start of second-line therapy or death (up to 2 years)
Chemotherapy Completion Rate
The proportion of subjects who complete ≥ 75% of the planned (6-8 cycles) first-line platinum-based chemotherapy cycles.
Measured: During the first-line chemotherapy phase (approximately within 18 weeks)
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.
Measured: Baseline, Weeks 3, 6, 9, 12, 15, 18, 22, 26
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.
Measured: Baseline, Weeks 3, 6, 9, 12, 15, 18, 22, 26
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.
Measured: Baseline, Weeks 6, 12, 18, 22, 26
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.
Measured: Baseline, Weeks 6, 12, 18, 22, 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completion30 Sep 2029 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian Neoplasms MalignantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Municipal Hospital of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Obstetrics & Gynecology Hospital of Fudan University, Fudan University, Shanghai Mental Health Center, First Affiliated Hospital of the Chinese People's Liberation Army Naval Medical University
- Responsible party
- Sponsor
- Investigators
- Jianhui Tian, Study chair, Shanghai Hospital of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07550205
- Sponsor's protocol ID
- 25Y12800600
- Status last verified
- Apr 2026
- First submitted
- 21 Mar 2026
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tiaoshen Anti-cancer Protocol and CBT for Insomnia and Survival in Ovarian Cancer: A Multicenter Randomized Trial
- ClinicalTrials.gov ID
- NCT07550205
- Acronym / sponsor ID
- 25Y12800600
- Conditions
- Ovarian Neoplasms Malignant, Sleep Initiation and Maintenance Disorders, Medicine, Chinese Traditional, Chinese Herbal Medicine, Cognitive Behavioral Therapy
- Keywords
- Ovarian Cancer, Cancer-Related Insomnia, Traditional Chinese Medicine, Cognitive Behavioral Therapy for Insomnia, Randomized Controlled Trial, Progression-Free Survival
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Shanghai Municipal Hospital of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Obstetrics & Gynecology Hospital of Fudan University, Fudan University, Shanghai Mental Health Center, First Affiliated Hospital of the Chinese People's Liberation Army Naval Medical University
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 30 Sep 2029 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 24 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This clinical trial investigates a novel integrative approach for managing cancer-related insomnia in advanced ovarian cancer. Targeting a prevalent yet under-addressed issue affecting over 60% of patients, the study evaluates the synergistic effect of combining the Tiaoshen Anti-cancer Protocol, a patented Traditional Chinese Medicine formula, with standard Cognitive Behavioral Therapy for Insomnia (CBT-I). In this multicenter, randomized, double-blind, placebo-controlled trial, approximately 360 patients with FIGO stage III-IV ovarian cancer and clinically significant insomnia will be randomized to receive either active Tiaoshen herbal granules or matched placebo for 18 weeks, with both groups concurrently receiving structured CBT-I. The co-primary endpoints are the improvement in sleep quality, measured by the Pittsburgh Sleep Quality Index response rate, and progression-free survival. Secondary objectives include assessing impacts on anxiety, depression, quality of life, and exploring predictive biomarkers. The study employs a two-stage adaptive design, where initial responders may be re-randomized to evaluate the added benefit of a mind-body exercise in a maintenance phase. This research aims to provide high-level evidence for a holistic strategy to break the "insomnia-progression" cycle, ultimately seeking to improve both quality of life and survival outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tiaoshen Anti-cancer GranulesThis 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. | Drug | Tiaoshen Granules + CBT-I Group, Tiaoshen Granules + Daoyin Group, Tiaoshen Granules Only Group |
| Placebo GranulesThis 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. | Drug | Placebo + CBT-I Grou |
| Cognitive Behavioral Therapy for InsomniaThis 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. | Behavioural | Placebo + CBT-I Grou, Tiaoshen Granules + CBT-I Group |
| Standard First-line Platinum-based ChemotherapyThis 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. | Other | Placebo + CBT-I Grou, Tiaoshen Granules + CBT-I Group |
| Sleep-Regulating Daoyin ExercisesThis 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. | Behavioural | Tiaoshen Granules + Daoyin Group |
| Standard Maintenance TherapyThis 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. | Other | Tiaoshen Granules + Daoyin Group, Tiaoshen Granules Only Group |
Primary outcome
PSQI Response Rate
Time frame: Baseline, Week 18
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
Time frame: From randomization, assessed continuously up to 2 years
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.
8 secondary outcomes
1-Year Progression-Free Survival Rate
Time frame: 1 year after randomization
2-Year Progression-Free Survival Rate
Time frame: 2 years after randomization
Time to First Subsequent Therapy
Time frame: From the end of first-line therapy, assessed until start of second-line therapy or death (up to 2 years)
Chemotherapy Completion Rate
Time frame: During the first-line chemotherapy phase (approximately within 18 weeks)
Change in Patient Health Questionnaire-9 Score
Time frame: Baseline, Weeks 3, 6, 9, 12, 15, 18, 22, 26
Change in Generalized Anxiety Disorder-7 Score
Time frame: Baseline, Weeks 3, 6, 9, 12, 15, 18, 22, 26
Change in EORTC QLQ-C30 Score
Time frame: Baseline, Weeks 6, 12, 18, 22, 26
Change in TCM Syndrome Score
Time frame: Baseline, Weeks 6, 12, 18, 22, 26
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Individual participant dataSharing planned: 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.
Related trials for Ovarian Neoplasms Malignant
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Recruiting
A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer
Ovarian Carcinoma
RecruitingPhase 2
Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer
Ovarian Cancer, Fallopian Tube Cancer
Active, not recruitingPhase 1/2
Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...
Colorectal Neoplasms, Breast Neoplasms
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jianhui Tian study chair
Shanghai Hospital of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Tiaoshen Anti-cancer Granules, Cognitive Behavioral Therapy for Insomnia and Standard First-line Platinum-based Chemotherapy in people with Ovarian Neoplasms Malignant and Sleep Initiation and Maintenance Disorders, run by Shanghai Municipal Hospital of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jianhui Tian, M.D. (86+18917763382, tjhhawk@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PSQI Response Rate (time frame: Baseline, Week 18). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.