NCT07050563Not yet recruiting
Clinical Evaluation of the Tiaoshen Anti-Cancer Regimen in Treating Psycho-Neurological Symptom Cluster in Ovarian Cancer
Source: ClinicalTrials.gov · Last updated 29 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 316 (estimated)
- First submitted
- 11 Jun 2025
- Start date
- 6 Oct 2025
- Primary completion date
- 1 Sept 2028
- Lead sponsor
- Shanghai Municipal Hospital of Traditional Chinese Medicine
- Diseases
- Ovarian cancer
- NCT number
- NCT07050563
What you commit to
- Study type: Interventional
- Planned participants: 316
- From 6 Oct 2025 to the primary completion date, 1 Sept 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients scheduled to undergo radiotherapy within the next 4 treatment cycles
- Pre-existing chronic insomnia or depression diagnosed prior to ovarian cancer
Other illness
- 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
- Comorbid autoimmune diseases, hematologic disorders, or long-term use of corticosteroids/immunosuppressants
- History of other primary malignancies
- HIV-positive status, congenital/acquired immunodeficiency disorders, or history of organ transplantation (including autologous bone marrow or peripheral stem cell transplantation)
- 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
Lab values
- 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)
Other
- Participation in other clinical trials within 3 months
- Legally incapacitated individuals, or cases with medical/ethical contraindications to study continuation
Who the study is looking for
- 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
Age in the registry: 18 years to 70 years · Sex: Female · Does not accept healthy volunteers
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.