ovarian cancer
Conditions
Interventions
Control group:The intervention adopts "placebo granules + CBT-I + standard first-line platinum-based chemotherapy regimen", with an intervention period of 18 weeks.
Intervention Group:Undergoes "Tiao Shen Zhi Ai Fang Granules + CBT-I + standard first-line platinum-based chemotherapy regimen", with an intervention period of 18 weeks.
Sequential control group:On the basis of ongoing Western maintenance therapy, Tiaoshen Zhiai Formula granules were administered sequentially. 8 weeks.
Sequential trial group:On the basis of ongoing Western maintenance therapy, Tiaoshen Zhiai Formula granules were administered sequentially, combined with regulating-sleep Daoyin therapy.
Sponsors
Shanghai Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
Female
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Patients aged 18-80 years; (2) PS score of 0-2; (3) Histopathological or cytological confirmation of primary epithelial ovarian cancer, with postoperative FIGO staging of III-IV, and planned to undergo postoperative standard first-line platinum-based chemotherapy; (4) Have undergone ovarian cancer debulking surgery, and at the time of enrollment are in a stable phase (without active infection, severe liver or kidney damage, etc.), and planned to undergo postoperative standard first-line platinum-based chemotherapy; (5) Meet the diagnostic criteria for ovarian cancer-related insomnia, with symptoms including: difficulty falling asleep, sleep maintenance difficulties (night awakenings =2 times), early morning awakening with inability to fall back asleep, occurring at least 3 times per week and persisting for =1 month; (6) Possess the ability to understand questionnaires and undergo CBT-I treatment (e.g., MMSE =24 points or education level above elementary school); (7) Have signed the informed consent form, voluntarily accept this treatment plan, and are able to independently complete a sleep diary.
Exclusion criteria
Exclusion criteria: (1) Has previously received systematic CBT-I treatment (to avoid learning effects); (2) Has a history of long-term chronic insomnia and mental disorders such as depression before the diagnosis of ovarian cancer, with a depression scale score on the health questionnaire =15 points and a generalized anxiety scale score =15 points, and a history of long-term use of sleep medications or psychiatric drugs; (3) Is pregnant, breastfeeding, or has severe diseases of important systems such as heart, brain, blood vessels, lungs, liver, kidneys, or hematopoietic system; (4) Has language barriers; (5) Has autoimmune diseases, congenital or acquired immunodeficiency diseases, hematological diseases, or a history of long-term use of hormones or immunosuppressants; (6) Has active hepatitis B, active tuberculosis, or other severe or uncontrolled inflammatory conditions (e.g., unstable or non-compensated respiratory, cardiovascular, liver, or kidney infections); (7) Has no history of long-term alcohol dependence; (8) Has primary tumors in other locations; (9) Has participated in other clinical trials within the past 3 months; (10) Lacks legal capacity or has medical or ethical reasons that may affect the continuation of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index (PSQI) Sleep Scale;Sleep quality; | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient Health Questionnaire-9 (PHQ-9) Depression Scale;Generalized Anxiety Disorder 7-item (GAD-7) Anxiety Scale ;EORTC QOL-C30 Scale (Quality of Life Questionnaire-Core 30);TCM Syndrome Pattern Assessment Scale;Syndrome Elements Questionnaire;Progression-Free Survival(PFS);1-year/2-year progression-free survival rate;Time to First Subsequent Therapy;Chemotherapy Completion Rate;Cancer Antigen 125(CA125);Risk of Ovarian Malignancy Algorithm;Human Epididymis Protein 4(HE4);Sleep diary; | — |
Countries
China
Contacts
Public ContactJianhui Tian
Shanghai Hospital of Traditional Chinese Medicine
Outcome results
None listed