Clinical trial · Interventional
Clinical Evaluation of the Tiaoshen Anti-Cancer Regimen in Treating Psycho-Neurological Symptom Cluster in Ovarian Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Cancer Symptom Clusters | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Compound Ciwujia Granules | Drug | — | UNRESOLVED |
| Placebo granules | Drug | — | UNRESOLVED |
| Standard treatment protocol for ovarian cancer combined with psychological intervention. | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention Group
- description
- Daily Compound Ciwujia granules+ standard treatment protocol for ovarian cancer+ psychological intervention
- interventionNames
- Drug: Compound Ciwujia Granules
- Combination Product: Standard treatment protocol for ovarian cancer combined with psychological intervention.
- type
- PLACEBO_COMPARATOR
- label
- Control group
- description
- Daily placebo granules + standard treatment protocol for ovarian cancer+ psychological intervention
- interventionNames
- Drug: Placebo granules
- Combination Product: Standard treatment protocol for ovarian cancer combined with psychological intervention.
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available