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

NCT07050563 | Not Yet Recruiting DMC

• 1 other identifier: 2024ZD0521402
• Study Type: interventional
• Target: 316
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Cancer; Cancer Symptom Clusters

Outcome Measures

Primary Outcomes (1)

• 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)

  Assessments at baseline and at 1, 2, 3, 6, 9 and 12 months post-enrollment

Secondary Outcomes (7)

• Piper Fatigue Scale

  Assessments at baseline and at 1, 2, 3, 6, 9 and 12 months post-enrollment

• Pittsburgh Sleep Quality Index (PSQI) Sleep Scale

  Assessments at baseline and at 1, 2, 3, 6, 9 and 12 months post-enrollment

• Patient Health Questionnaire-9 (PHQ-9) Depression Scale

  Assessments at baseline and at 1, 2, 3, 6, 9 and 12 months post-enrollment

• Chinese Traditional Medicine Syndrome Pattern Assessment Scale

  Assessments at baseline and at 1, 2, 3, 6, 9 and 12 months post-enrollment

• EORTC QOL-C30 Scale

  Assessments at baseline and at 1, 2, 3, 6, 9 and 12 months post-enrollment

Other Outcomes (26)

• Sleep quality

  Assessments at baseline and at 1, 2, and 3 months post-enrollment

• Sleep diary

  Assessments at baseline and at 1, 2, and 3 months post-enrollment

• Functional magnetic resonance imaging (fMRI)

  Assessed at baseline and 3 months post-enrollment

Study Arms (2)

Intervention Group

EXPERIMENTAL

Daily Compound Ciwujia granules+ standard treatment protocol for ovarian cancer+ psychological intervention

Drug: Compound Ciwujia Granules; Combination Product: Standard treatment protocol for ovarian cancer combined with psychological intervention.

Control group

PLACEBO COMPARATOR

Daily placebo granules + standard treatment protocol for ovarian cancer+ psychological intervention

Drug: Placebo granules; Combination Product: Standard treatment protocol for ovarian cancer combined with psychological intervention.

Interventions

Compound Ciwujia Granules DRUG

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.

Intervention Group

Placebo granules DRUG

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.

Control group

Standard treatment protocol for ovarian cancer combined with psychological intervention. COMBINATION_PRODUCT

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.

Control group; Intervention Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Municipal Hospital of Traditional Chinese Medicine: lead
• 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

MeSH Terms

Conditions

Neoplasms

Interventions

Psychosocial Intervention

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Jianhui Tian, Doctor

  Shanghai Municipal Hospital of Traditional Chinese Medicine - Oncology Research Center

  STUDY DIRECTOR

Central Study Contacts

Ze Liu, Master

CONTACT

86-13069967983; lzlz1136491317@163.com

Jialiang Yao, Doctor

CONTACT

jialiangyao@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2025
• First Posted: July 3, 2025
• Study Start: October 6, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): November 30, 2028
• Last Updated: September 29, 2025

Record last verified: 2025-09