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| Name | Class |
|---|---|
| Guangdong Provincial Hospital of Traditional Chinese Medicine | OTHER |
| Affiliated Hospital of Qinghai University | OTHER |
| Obstetrics & Gynecology Hospital of Fudan University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | Daily Compound Ciwujia granules+ standard treatment protocol for ovarian cancer+ psychological intervention |
|
| Control group | Placebo Comparator | Daily placebo granules + standard treatment protocol for ovarian cancer+ psychological intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Compound Ciwujia Granules | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Assessments at baseline and at 1, 2, 3, 6, 9 and 12 months post-enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Piper Fatigue Scale | Assessments at baseline and at 1, 2, 3, 6, 9 and 12 months post-enrollment | |
| Pittsburgh Sleep Quality Index (PSQI) Sleep Scale | Assessments at baseline and at 1, 2, 3, 6, 9 and 12 months post-enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep quality | Assessing sleep quality using a portable wristband. | Assessments at baseline and at 1, 2, and 3 months post-enrollment |
| Sleep diary | Record basic sleep metrics, such as daily bedtime, sleep onset time, number and duration of nighttime awakenings, and morning wake-up time. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ze Liu, Master | Contact | 86-13069967983 | lzlz1136491317@163.com | |
| Jialiang Yao, Doctor | Contact | jialiangyao@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Jianhui Tian, Doctor | Shanghai Municipal Hospital of Traditional Chinese Medicine - Oncology Research Center | Study Director |
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| Fudan University |
| OTHER |
| Beijing Hospital of Traditional Chinese Medicine | OTHER |
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| Placebo granules | Drug | 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. |
|
| Patient Health Questionnaire-9 (PHQ-9) Depression Scale | Assessments at baseline and at 1, 2, 3, 6, 9 and 12 months post-enrollment |
| Chinese Traditional Medicine Syndrome Pattern Assessment Scale | 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 | 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 | 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. | Determined at the 1-year follow-up after random assignment |
| Assessments at baseline and at 1, 2, and 3 months post-enrollment |
| Functional magnetic resonance imaging (fMRI) | Functional magnetic resonance imaging (fMRI) is planned for 30 randomly selected patients per group, totaling 60 participants. | Assessed at baseline and 3 months post-enrollment |
| Biological targets in peripheral blood | Using targeted proteomics, we detect differential protein expression in cancer patients with psychoneurological symptom clusters before and after treatment, with the goal of exploring potential actionable therapeutic targets. The study is to randomly select 50 cases from each group, totaling 100 patients for examination. | Assessments at baseline and 3 months post-enrollment |
| Biological targets in tumor tissue | Utilizing exclusively pre-treatment tumor tissues, we performed targeted proteomics to detect differential protein expression between cancer patients exhibiting psychoneurological symptom clusters and cancer-free healthy controls. The study plan to randomly select 50 cases from each group, totaling 100 patients for examination. | Tumor tissue is collected exclusively at baseline |
| Heart rate | Safety indicator | Assessments at baseline and at 1, 2, 3, 6, 9 and 12 months post-enrollment |
| Respiration | Safety indicator | Assessments at baseline and at 1, 2, 3, 6, 9 and 12 months post-enrollment |
| Body temperature | Safety indicator | Assessments at baseline and at 1, 2, 3, 6, 9 and 12 months post-enrollment |
| Blood pressure | Safety indicator | Assessments at baseline and at 1, 2, 3, 6, 9 and 12 months post-enrollment |
| Alanine Aminotransferase (ALT) | Safety indicator | At baseline and 3 months after enrollment |
| Aspartate Aminotransferase(AST) | Safety indicator | Assessed at baseline and 3 months post-enrollment |
| Serum creatinine | Safety indicator | Assessed at baseline and 3 months post-enrollment |
| Urinary protein | Safety indicator | Assessed at baseline and 3 months post-enrollment |
| Urinary leukocytes | Safety indicator | Assessed at baseline and 3 months post-enrollment |
| White blood cells (WBC) | Safety indicator | Assessed at baseline and 3 months post-enrollment |
| Hemoglobin (Hb) | Safety indicator | Assessed at baseline and 3 months post-enrollment |
| Platelets (PLT) | Safety indicator | Assessed at baseline and 3 months post-enrollment |
| Adrenocorticotropic hormone (ACTH) | As indicator for assessing Hypothalamic-Pituitary-Adrenal(HPA) axis function, assayed via blood sampling. The study is to randomly select 50 cases from each group, totaling 100 patients for examination | Assessed at baseline and 3 months post-enrollment |
| Urinary free cortisol | As indicator for assessing Hypothalamic-Pituitary-Adrenal(HPA) axis function, assayed via urine sampling. The study is to randomly select 50 cases from each group, totaling 100 patients for examination | Assessed at baseline and 3 months post-enrollment |
| Plasma cortisol | As indicators for assessing Hypothalamic-Pituitary-Adrenal(HPA) axis function, assayed via blood sampling. The study is to randomly select 50 cases from each group, totaling 100 patients for examination. | Assessed at baseline and 3 months post-enrollment |
| Proportions of immune cells | Measure the proportions of immune cells such as T cells, B cells, and natural killer (NK) cells. The study is to randomly select 50 cases from each group, totaling 100 patients for examination. | Assessed at baseline and 3 months post-enrollment |
| Cytokine levels | Measure the expression levels of cytokines such as IL-6, IL-10, TNF-α, and IFN-γ. The study is to randomly select 50 cases from each group, totaling 100 patients for examination. | Assessed at baseline and 3 months post-enrollment |
| Immune gene expression analysis | Perform RNA sequencing analysis on patient samples to investigate expression changes in immune-related genes, with a specific focus on their roles in immune regulation. The study is to randomly select 50 cases from each group, totaling 100 patients for examination. | Assessed at baseline and 3 months post-enrollment |
| Tumor marker CA-125 | The unit of CA125 is U/ml. Indicators exceeding the normal range indicate a poor prognosis | Assessments at baseline and 3 months post-enrollment |
| Tumor marker Humanepididymisprotein4 (HE4) | The unit of HE4 is pmol/l. Indicators exceeding the normal range indicate a poor prognosis | Assessments at baseline and 3 months post-enrollment |
| Electrocardiogram | QT interval, as a safety indicator | Assessments at baseline and 3 months post-enrollment |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000083626 | Psychosocial Intervention |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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