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.
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;
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
Parallel
Compound Ciwujia Granules
DrugIn 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 granules
DrugIn 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 productStandard 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.
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)
Piper Fatigue Scale
Pittsburgh Sleep Quality Index (PSQI) Sleep Scale
Patient Health Questionnaire-9 (PHQ-9) Depression Scale
Chinese Traditional Medicine Syndrome Pattern Assessment Scale
Sleep quality
Assessing sleep quality using a portable wristband.
Sleep diary
Record basic sleep metrics, such as daily bedtime, sleep onset time, number and duration of nighttime awakenings, and morning wake-up time.
Functional magnetic resonance imaging (fMRI)
Functional magnetic resonance imaging (fMRI) is planned for 30 randomly selected patients per group, totaling 60 participants.
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.
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Shanghai Municipal Hospital of Traditional Chinese Medicine
Lead sponsor
Guangdong Provincial Hospital of Traditional Chinese Medicine
Collaborator
Affiliated Hospital of Qinghai University
Collaborator
Obstetrics & Gynecology Hospital of Fudan University
Collaborator
Fudan University
Collaborator
Beijing Hospital of Traditional Chinese Medicine
Collaborator
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