NCT Number: NCT07050563
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.
Trial opening soon.
Get Notified18 year–70 year
Female
Interventional
Not applicable
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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: 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.
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)
Time frame: Assessments at baseline and at 1, 2, 3, 6, 9 and 12 months post-enrollment
Time frame: Assessments at baseline and at 1, 2, 3, 6, 9 and 12 months post-enrollment
Time frame: Assessments at baseline and at 1, 2, 3, 6, 9 and 12 months post-enrollment
Time frame: Assessments at baseline and at 1, 2, 3, 6, 9 and 12 months post-enrollment
Time frame: Assessments at baseline and at 1, 2, 3, 6, 9 and 12 months post-enrollment
Quality of Life Questionnaire-Core 30
Time frame: Assessments at baseline and at 1, 2, 3, 6, 9 and 12 months post-enrollment
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
Time frame: Determined at the 1-year follow-up after random assignment
From randomization, patients underwent regular imaging assessments to determine 1-year overall survival (OS) and progression-free survival (PFS) rates.
Time frame: Assessments at baseline and at 1, 2, and 3 months post-enrollment
Assessing sleep quality using a portable wristband.
Time frame: Assessments at baseline and at 1, 2, and 3 months post-enrollment
Record basic sleep metrics, such as daily bedtime, sleep onset time, number and duration of nighttime awakenings, and morning wake-up time.
Time frame: Assessed at baseline and 3 months post-enrollment
Functional magnetic resonance imaging (fMRI) is planned for 30 randomly selected patients per group, totaling 60 participants.
Time frame: Assessments at baseline and 3 months post-enrollment
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.
Time frame: Tumor tissue is collected exclusively at baseline
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.
Time frame: Assessments at baseline and at 1, 2, 3, 6, 9 and 12 months post-enrollment
Safety indicator
Time frame: Assessments at baseline and at 1, 2, 3, 6, 9 and 12 months post-enrollment
Safety indicator
Time frame: Assessments at baseline and at 1, 2, 3, 6, 9 and 12 months post-enrollment
Safety indicator
Time frame: Assessments at baseline and at 1, 2, 3, 6, 9 and 12 months post-enrollment
Safety indicator
Time frame: At baseline and 3 months after enrollment
Safety indicator
Time frame: Assessed at baseline and 3 months post-enrollment
Safety indicator
Time frame: Assessed at baseline and 3 months post-enrollment
Safety indicator
Time frame: Assessed at baseline and 3 months post-enrollment
Safety indicator
Time frame: Assessed at baseline and 3 months post-enrollment
Safety indicator
Time frame: Assessed at baseline and 3 months post-enrollment
Safety indicator
Time frame: Assessed at baseline and 3 months post-enrollment
Safety indicator
Time frame: Assessed at baseline and 3 months post-enrollment
Safety indicator
Time frame: Assessed at baseline and 3 months post-enrollment
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
Time frame: Assessed at baseline and 3 months post-enrollment
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
Time frame: Assessed at baseline and 3 months post-enrollment
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.
Time frame: Assessed at baseline and 3 months post-enrollment
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.
Time frame: Assessed at baseline and 3 months post-enrollment
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.
Time frame: Assessed at baseline and 3 months post-enrollment
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.
Time frame: Assessments at baseline and 3 months post-enrollment
The unit of CA125 is U/ml. Indicators exceeding the normal range indicate a poor prognosis
Time frame: Assessments at baseline and 3 months post-enrollment
The unit of HE4 is pmol/l. Indicators exceeding the normal range indicate a poor prognosis
Time frame: Assessments at baseline and 3 months post-enrollment
QT interval, as a safety indicator
Contact information is provided by the study sponsor or research team.
Jialiang Yao, Doctor
CONTACT
Ze Liu, Master
CONTACT
Shanghai Municipal Hospital of Traditional Chinese Medicine
Other
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