Clinical Evaluation of the Tiaoshen Anti-Cancer Regimen in Treating Psycho-Neurological Symptom Cluster in Ovarian Cancer

Overview

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.

Interventions

• Drug Compound Ciwujia Granules
  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.
• Drug Placebo granules
  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.
• Combination product 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

Primary outcome measures

• Psychoneurological Symptom Cluster in Ovarian Cancer [Time frame: Assessments at baseline and at 1, 2, 3, 6, 9 and 12 months post-enrollment]

Secondary outcome measures (7)

• 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]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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
• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07050563 · 2024ZD0521402

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗