CancerNCT07050563
Clinical Evaluation of the Tiaoshen Anti-Cancer Regimen in Treating Psycho-Neurological Symptom Cluster in Ovarian Cancer
A study testing Compound Ciwujia Granules and Standard treatment protocol for ovarian cancer combined with psychological intervention. in people with Cancer and Cancer Symptom Clusters, run by Shanghai Municipal Hospital of Traditional Chinese Medicine.
Trial summary
The academic community generally believes that cancer symptom clusters (CSCs) are not independent diseases, but a group of symptoms that accompany cancer patients. Based on etiology, they can be classified into CSCs related to tumor progression, CSCs related to cancer treatment, or a combination of both. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Cancer, Cancer Symptom Clusters
- What is being tested?
- Compound Ciwujia Granules and Standard treatment protocol for ovarian cancer combined with psychological intervention.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 316 participants
- Where
- No sites listed yet
- Study dates
- 6 Oct 2025to 30 Nov 2028
- Phase
- Interventional
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed primary epithelial ovarian cancer
- Meet diagnostic criteria for chronic insomnia defined by the Sleep Disorders Group of the Neurology Branch of the Chinese Medical Association: Pittsburgh Sleep Quality Index (PSQI) total score >8 Piper Fatigue Scale total score >4 and Patient Health Questionnaire-9 (PHQ-9) total score >5
- Moderate-to-severe symptom severity (average score ≥4 on the MD Anderson Symptom Inventory for Ovarian Cancer [MDASI-OC] subscale assessing sleep disturbance-fatigue-distress-sadness)
- Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score 0-2;
- Age 18-70 years
- Meeting TCM diagnostic criteria for spleen-kidney yang deficiency syndrome;
- Expected survival >1 year
- Signed informed consent form with voluntary acceptance of the treatment protocol and ability to independently complete sleep diaries
Who cannot join
- Patients scheduled to undergo radiotherapy within the next 4 treatment cycles
- Comorbid severe primary diseases of the heart, brain, liver, kidney, or hematopoietic system, including hepatic dysfunction (AST/ALT >1.5 times the upper limit of normal [ULN]) or renal impairment (serum creatinine [Cr] >1.2 times ULN)
- Pregnant or lactating women, individuals with psychiatric disorders (e.g., schizophrenia, bipolar disorder, mania, depression, anxiety disorders, phobias), intellectual/language impairments, or other mental health conditions;
- Scores ≥15 on the Patient Health Questionnaire (PHQ-9) for depression or ≥15 on the Generalized Anxiety Disorder-7 (GAD-7) at screening
- Pre-existing chronic insomnia or depression diagnosed prior to ovarian cancer
- Comorbid autoimmune diseases, hematologic disorders, or long-term use of corticosteroids/immunosuppressants
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- History of other primary malignancies
- Participation in other clinical trials within 3 months
- HIV-positive status, congenital/acquired immunodeficiency disorders, or history of organ transplantation (including autologous bone marrow or peripheral stem cell transplantation)
- Legally incapacitated individuals, or cases with medical/ethical contraindications to study continuation
- Active hepatitis B, active tuberculosis, or evidence of severe/uncontrolled systemic inflammatory conditions (e.g., unstable respiratory, cardiovascular, hepatic, or renal diseases)
- Patients with diabetes
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Jialiang Yao, Doctor contact
About this study
The academic community generally believes that cancer symptom clusters (CSCs) are not independent diseases, but a group of symptoms that accompany cancer patients. Based on etiology, they can be classified into CSCs related to tumor progression, CSCs related to cancer treatment, or a combination of both. According to symptom manifestations, they can be divided into psychological symptom CSCs, somatic symptom CSCs, and CSCs with coexisting psychological and somatic symptoms. CSCs are universally present during the progression or treatment of cancer. Traditional Chinese medicine (TCM) can leverage its unique characteristics in the intervention of symptom clusters and symptom management. This study is planned to conduct a high-level, prospective, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of a TCM regimen for cancer symptom clusters (CSCs), and to simultaneously analyze the characteristics of the population that may benefit most from TCM treatment for CSCs.
Read the detailed description
Targeting ovarian cancer patients with psychoneurological symptom clusters, a multicenter, randomized, placebo-controlled, superiority clinical trial was conducted. On the basis of psychological intervention and conventional cancer treatment, the treatment group and the control group respectively received Compound Ciwujia Granules or a placebo. The intervention lasted for three months, with the alleviation of psychoneurological symptoms assessed before and after treatment in both groups.
The primary efficacy endpoint was the mean score of the subscale comprising sleep disturbance, fatigue, distress, and sadness from the Chinese version of the MD Anderson Symptom Inventory for Ovarian Cancer (MDASI-OC). Secondary efficacy endpoints included the EORTC QLQ-C30 quality of life scale, sleep quality assessment, and sleep diaries. Exploratory endpoints included the 1-year overall survival (OS) rate and progression-free survival (PFS) rate. Peripheral blood samples and tumor tissue specimens were collected to investigate common biological targets underlying the psychoneurological symptom cluster in ovarian cancer.
- Conditions
- Cancer, Cancer Symptom Clusters
- Being tested
- Compound Ciwujia Granules, Placebo granules, Standard treatment protocol for ovarian cancer combined with psychological intervention.
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compound Ciwujia GranulesDrug
In addition to standard treatment protocol for ovarian cancer combined with psychological intervention, Compound Ciwujia Granules were administered at a dosage of one sachet twice daily for a treatment duration of 3 months.
Placebo granulesDrug
In addition to standard treatment protocol for ovarian cancer combined with psychological intervention, placebo granules which containing 10% of Compound Ciwujia Granules drug were administered at a dosage of one sachet twice daily for a treatment duration of 3 months.
Standard treatment protocol for ovarian cancer combined with psychological intervention.Combination product
Standard treatment protocol for ovarian cancer: In accordance with the 2024 NCCN International Guidelines, patients opt for chemotherapy regimens containing platinum-based drugs and/or targeted therapy, anti-angiogenic therapy, hormonal therapy, etc. Psychological intervention is conducted once a week in the form of online and offline patient education sessions for psychological intervention, continuing until the end of the study period. Both the intervention group and the control group use this as the baseline treatment plan.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Daily Compound Ciwujia granules+ standard treatment protocol for ovarian cancer+ psychological intervention Receives: Drug: Compound Ciwujia Granules; Combination Product: Standard treatment protocol for ovarian cancer combined with psychological intervention. |
| Control group | Placebo comparator | Daily placebo granules + standard treatment protocol for ovarian cancer+ psychological intervention Receives: Drug: Placebo granules; Combination Product: Standard treatment protocol for ovarian cancer combined with psychological intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychoneurological Symptom Cluster in Ovarian Cancer
Mean score of the subscale composed of sleep disturbance, fatigue, distress, and sadness in the MD Anderson Symptom Inventory for ovarian cancer (MDASI-OC)
Measured: Assessments at baseline and at 1, 2, 3, 6, 9 and 12 months post-enrollment
Secondary outcomes (7)
Piper Fatigue Scale
Measured: Assessments at baseline and at 1, 2, 3, 6, 9 and 12 months post-enrollment
Pittsburgh Sleep Quality Index (PSQI) Sleep Scale
Measured: Assessments at baseline and at 1, 2, 3, 6, 9 and 12 months post-enrollment
Patient Health Questionnaire-9 (PHQ-9) Depression Scale
Measured: Assessments at baseline and at 1, 2, 3, 6, 9 and 12 months post-enrollment
Chinese Traditional Medicine Syndrome Pattern Assessment Scale
Measured: Assessments at baseline and at 1, 2, 3, 6, 9 and 12 months post-enrollment
EORTC QOL-C30 Scale
Quality of Life Questionnaire-Core 30
Measured: Assessments at baseline and at 1, 2, 3, 6, 9 and 12 months post-enrollment
Generalized Anxiety Disorder 7-item (GAD-7) Anxiety Scale
It is a self-assessment tool used to evaluate the severity of anxiety symptoms, consisting of 7 questions with a total score ranging from 0 to 21 points. It can be divided into 4 grades, and the higher the score, the more severe the condition
Measured: Assessments at baseline and at 1, 2, 3, 6, 9 and 12 months post-enrollment
1-year survival analysis
From randomization, patients underwent regular imaging assessments to determine 1-year overall survival (OS) and progression-free survival (PFS) rates.
Measured: Determined at the 1-year follow-up after random assignment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start6 Oct 2025 (estimated)
- Primary completion1 Sep 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 316 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Municipal Hospital of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Guangdong Provincial Hospital of Traditional Chinese Medicine, Affiliated Hospital of Qinghai University, Obstetrics & Gynecology Hospital of Fudan University, Fudan University, Beijing Hospital of Traditional Chinese Medicine
- Responsible party
- Sponsor
- Investigators
- Jianhui Tian, Doctor, Study director, Shanghai Municipal Hospital of Traditional Chinese Medicine - Oncology Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07050563
- Sponsor's protocol ID
- 2024ZD0521402
- Status last verified
- Sep 2025
- First submitted
- 11 Jun 2025
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Liu Z, Yao J, Lu X, Yang Y, Luo B, Wang Y, Cheng X, Jiang W, Yang G, Xiao J, Zhao J, Tian J. Evaluation of the TiaoShenZhiAi Regimen for Patients With Ovarian Cancer Experiencing a Psychoneurological Symptom Cluster: Protocol for a Multicenter, Double-Blind, Randomized Controlled Trial. JMIR Res Protoc. 2026 Jun 12;15:e88625. doi: 10.2196/88625.
PubMed 42284089
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Tiaoshen Anti-Cancer Regimen in Treating Psycho-Neurological Symptom Cluster in Ovarian Cancer
- ClinicalTrials.gov ID
- NCT07050563
- Acronym / sponsor ID
- 2024ZD0521402
- Conditions
- Cancer, Cancer Symptom Clusters
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 316 participants (estimated)
- Lead sponsor
- Shanghai Municipal Hospital of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Guangdong Provincial Hospital of Traditional Chinese Medicine, Affiliated Hospital of Qinghai University, Obstetrics & Gynecology Hospital of Fudan University, Fudan University, Beijing Hospital of Traditional Chinese Medicine
- Study start
- 6 Oct 2025 (estimated)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 3 Jul 2025 (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.
The academic community generally believes that cancer symptom clusters (CSCs) are not independent diseases, but a group of symptoms that accompany cancer patients. Based on etiology, they can be classified into CSCs related to tumor progression, CSCs related to cancer treatment, or a combination of both. According to symptom manifestations, they can be divided into psychological symptom CSCs, somatic symptom CSCs, and CSCs with coexisting psychological and somatic symptoms. CSCs are universally present during the progression or treatment of cancer. Traditional Chinese medicine (TCM) can leverage its unique characteristics in the intervention of symptom clusters and symptom management. This study is planned to conduct a high-level, prospective, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of a TCM regimen for cancer symptom clusters (CSCs), and to simultaneously analyze the characteristics of the population that may benefit most from TCM treatment for CSCs.
Detailed description
Targeting ovarian cancer patients with psychoneurological symptom clusters, a multicenter, randomized, placebo-controlled, superiority clinical trial was conducted. On the basis of psychological intervention and conventional cancer treatment, the treatment group and the control group respectively received Compound Ciwujia Granules or a placebo. The intervention lasted for three months, with the alleviation of psychoneurological symptoms assessed before and after treatment in both groups.
The primary efficacy endpoint was the mean score of the subscale comprising sleep disturbance, fatigue, distress, and sadness from the Chinese version of the MD Anderson Symptom Inventory for Ovarian Cancer (MDASI-OC). Secondary efficacy endpoints included the EORTC QLQ-C30 quality of life scale, sleep quality assessment, and sleep diaries. Exploratory endpoints included the 1-year overall survival (OS) rate and progression-free survival (PFS) rate. Peripheral blood samples and tumor tissue specimens were collected to investigate common biological targets underlying the psychoneurological symptom cluster in ovarian cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Drug: Compound Ciwujia Granules, Combination Product: Standard treatment protocol for ovarian cancer combined with psychological intervention.Daily Compound Ciwujia granules+ standard treatment protocol for ovarian cancer+ psychological intervention |
| Control group | Placebo comparator | Drug: Placebo granules, Combination Product: Standard treatment protocol for ovarian cancer combined with psychological intervention.Daily placebo granules + standard treatment protocol for ovarian cancer+ psychological intervention |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically or cytologically confirmed primary epithelial ovarian cancer
- Meet diagnostic criteria for chronic insomnia defined by the Sleep Disorders Group of the Neurology Branch of the Chinese Medical Association: Pittsburgh Sleep Quality Index (PSQI) total score >8 Piper Fatigue Scale total score >4 and Patient Health Questionnaire-9 (PHQ-9) total score >5
- Moderate-to-severe symptom severity (average score ≥4 on the MD Anderson Symptom Inventory for Ovarian Cancer [MDASI-OC] subscale assessing sleep disturbance-fatigue-distress-sadness)
- Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score 0-2;
- Age 18-70 years
Key exclusion criteria (12 listed)
- Patients scheduled to undergo radiotherapy within the next 4 treatment cycles
- Comorbid severe primary diseases of the heart, brain, liver, kidney, or hematopoietic system, including hepatic dysfunction (AST/ALT >1.5 times the upper limit of normal [ULN]) or renal impairment (serum creatinine [Cr] >1.2 times ULN)
- Pregnant or lactating women, individuals with psychiatric disorders (e.g., schizophrenia, bipolar disorder, mania, depression, anxiety disorders, phobias), intellectual/language impairments, or other mental health conditions;
- Scores ≥15 on the Patient Health Questionnaire (PHQ-9) for depression or ≥15 on the Generalized Anxiety Disorder-7 (GAD-7) at screening
- Pre-existing chronic insomnia or depression diagnosed prior to ovarian cancer
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 |
|---|---|---|
| Compound Ciwujia GranulesIn addition to standard treatment protocol for ovarian cancer combined with psychological intervention, Compound Ciwujia Granules were administered at a dosage of one sachet twice daily for a treatment duration of 3 months. | Drug | Intervention Group |
| Placebo granulesIn addition to standard treatment protocol for ovarian cancer combined with psychological intervention, placebo granules which containing 10% of Compound Ciwujia Granules drug were administered at a dosage of one sachet twice daily for a treatment duration of 3 months. | Drug | Control group |
| Standard treatment protocol for ovarian cancer combined with psychological intervention.Standard treatment protocol for ovarian cancer: In accordance with the 2024 NCCN International Guidelines, patients opt for chemotherapy regimens containing platinum-based drugs and/or targeted therapy, anti-angiogenic therapy, hormonal therapy, etc. Psychological intervention is conducted once a week in the form of online and offline patient education sessions for psychological intervention, continuing until the end of the study period. Both the intervention group and the control group use this as the baseline treatment plan. | Combination product | Control group, Intervention Group |
Primary outcome
Psychoneurological Symptom Cluster in Ovarian Cancer
Time frame: Assessments at baseline and at 1, 2, 3, 6, 9 and 12 months post-enrollment
Mean score of the subscale composed of sleep disturbance, fatigue, distress, and sadness in the MD Anderson Symptom Inventory for ovarian cancer (MDASI-OC)
7 secondary outcomes
Piper Fatigue Scale
Time frame: Assessments at baseline and at 1, 2, 3, 6, 9 and 12 months post-enrollment
Pittsburgh Sleep Quality Index (PSQI) Sleep Scale
Time frame: Assessments at baseline and at 1, 2, 3, 6, 9 and 12 months post-enrollment
Patient Health Questionnaire-9 (PHQ-9) Depression Scale
Time frame: Assessments at baseline and at 1, 2, 3, 6, 9 and 12 months post-enrollment
Chinese Traditional Medicine Syndrome Pattern Assessment Scale
Time frame: Assessments at baseline and at 1, 2, 3, 6, 9 and 12 months post-enrollment
EORTC QOL-C30 Scale
Time frame: Assessments at baseline and at 1, 2, 3, 6, 9 and 12 months post-enrollment
Generalized Anxiety Disorder 7-item (GAD-7) Anxiety Scale
Time frame: Assessments at baseline and at 1, 2, 3, 6, 9 and 12 months post-enrollment
1-year survival analysis
Time frame: Determined at the 1-year follow-up after random assignment
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 29 Sep 2025.
- Derived from this study: PubMed 42284089Liu Z, Yao J, Lu X, Yang Y, Luo B, Wang Y, Cheng X, Jiang W, Yang G, Xiao J, Zhao J, Tian J. Evaluation of the TiaoShenZhiAi Regimen for Patients With Ovarian Cancer Experiencing a Psychoneurological Symptom Cluster: Protocol for a Multicenter, Double-Blind, Randomized Controlled Trial. JMIR Res Protoc. 2026 Jun 12;15:e88625. doi: 10.2196/88625.
- Individual participant dataSharing planned: Undecided
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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.
Jialiang Yao, Doctor contact
Jianhui Tian, Doctor study director
Shanghai Municipal Hospital of Traditional Chinese Medicine - Oncology Research Center
Questions about this trial
What is this clinical trial studying?
A study testing Compound Ciwujia Granules and Standard treatment protocol for ovarian cancer combined with psychological intervention. in people with Cancer and Cancer Symptom Clusters, run by Shanghai Municipal Hospital of Traditional Chinese Medicine.
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 8 inclusion and 12 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 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
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 Ze Liu, Master (86-13069967983, lzlz1136491317@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychoneurological Symptom Cluster in Ovarian Cancer (time frame: Assessments at baseline and at 1, 2, 3, 6, 9 and 12 months post-enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07050563, which also lists 1 linked publication.
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 29 Sep 2025.