Chinese herbal granules plus talk therapy for sleep problems in ovarian cancer
Tests herbal granules with insomnia therapy in women with advanced ovarian cancer.
Plain-language title generated from the registry record
Registry title: Tiaoshen Anti-cancer Protocol and CBT for Insomnia and Survival in Ovarian Cancer
Key facts
- Where
- Shanghai, ChinaSee the site
- Phase
- Phase 2/3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for women with advanced ovarian cancer who have long-lasting sleep problems. They are about to start chemotherapy after surgery.
- Age
- 18 to 80 years
- Sex
- Women only
- Disease stage
- Primary epithelial ovarian cancer, FIGO stage III-IV, after debulking surgery, in stable condition, with cancer-related insomnia (at least 3 times a week for at least 1 month).
- Earlier treatment
- Must have had ovarian cancer debulking surgery and be planned for first-line platinum-based chemotherapy after surgery. Cannot have had a full course of Cognitive Behavioral Therapy for Insomnia before.
Main reasons for not taking part
- Pregnant or breastfeeding women
- Severe heart, brain, lung, liver, kidney or blood diseases
- Autoimmune or immune deficiency disease, or long-term use of corticosteroids or immunosuppressants
- Active hepatitis B, active tuberculosis or other severe infection
- Another primary cancer, or another clinical trial in the last 3 months
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT07550205, who can take part
Where in China
- Shanghai Hospital of Traditional Chinese MedicineShanghai, ChinaContact: Jianhui TianNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Shanghai Municipal Hospital of Traditional Chinese Medicine
- Trial code
- NCT07550205
- Record updated
- 24 April 2026
- Original description
Study Title: A Multicenter, Randomized Controlled Trial of Tiaoshen Anti-cancer Protocol Combined with Cognitive Behavioral Therapy for Insomnia in Improving Sleep and Survival in Ovarian Cancer Patients Purpose: This study aims to evaluate whether a combined therapy of traditional Chinese medicine (TCM) and modern psychotherapy can improve sleep and potentially extend survival for patients with ovarian cancer. Many patients experience severe, cancer-related insomnia, which lowers quality of life and may affect treatment outcomes.Read full original descriptionShow less
Tiaoshen Anti-cancer Protocol and CBT for Insomnia and Survival in Ovarian Cancer: A Multicenter Randomized Trial
Study Title: A Multicenter, Randomized Controlled Trial of Tiaoshen Anti-cancer Protocol Combined with Cognitive Behavioral Therapy for Insomnia in Improving Sleep and Survival in Ovarian Cancer Patients Purpose: This study aims to evaluate whether a combined therapy of traditional Chinese medicine (TCM) and modern psychotherapy can improve sleep and potentially extend survival for patients with ovarian cancer. Many patients experience severe, cancer-related insomnia, which lowers quality of life and may affect treatment outcomes.
Intervention \& Design: This is a randomized, double-blind, placebo-controlled trial conducted across multiple hospitals. Approximately 360 eligible patients with advanced ovarian cancer and significant insomnia will be enrolled.
Participants will be randomly assigned to one of two groups for the initial 18-week phase:
Experimental Group: Receives the Tiaoshen Anti-cancer herbal formula granules plus standard Cognitive Behavioral Therapy for Insomnia (CBT-I).
Control Group: Receives inactive placebo granules plus the same standard CBT-I. Neither the participants nor their treating doctors will know which granules are assigned during this phase. The primary goal is to compare the improvement in sleep quality between the two groups. Key secondary goals include assessing the therapy's impact on patients' anxiety, depression, overall quality of life, and the length of time before the cancer progresses (progression-free survival). All patients will receive standard-of-care chemotherapy.
Inclusion: Patients aged 18 to 80 years (inclusive); Performance status (PS) score of 0-2; Histologically or cytologically confirmed primary epithelial ovarian carcinoma, with postoperative FIGO stage III-IV, and scheduled to receive postoperative standard first-line platinum-based chemotherapy; Having undergone ovarian cancer debulking surgery, in a stable condition at enrollment (no active infection, no severe hepatic or renal impairment, etc.), and planned for postoperative first-line platinum-based chemotherapy; Meeting the diagnostic criteria for ovarian cancer-related insomnia (difficulty initiating sleep, sleep maintenance disturbance [nocturnal awakening ≥2 times], early morning awakening with inability to return to sleep, occurring ≥3 times per week and lasting ≥1 month); Possess the ability to comprehend assessment scales and undergo Cognitive Behavioral Therapy for Insomnia (e.g., Mini-Mental State Examination score ≥24, or education level above primary school); Voluntarily sign the informed consent form, agree to receive the study treatment, and able to independently complete a sleep diary.
Exclusion: Previous systematic treatment with Cognitive Behavioral Therapy for Insomnia; History of chronic insomnia, depression, or other psychiatric disorders prior to ovarian cancer diagnosis, AND with a Patient Health Questionnaire-9 score ≥15 and a Generalized Anxiety Disorder-7 score ≥15, AND long-term use of hypnotic or psychotropic medications; Language barriers that would prevent completion of assessments or therapy; Concurrent other primary malignant tumors (except for cured non-melanoma skin cancer, carcinoma in situ of the cervix, etc.); Participation in any other clinical trial within 3 months prior to enrollment; Comorbid severe primary diseases of the cardiovascular, cerebrovascular, pulmonary, hepatic, renal, or hematopoietic systems; Comorbid autoimmune diseases, congenital or acquired immunodeficiency diseases, hematological diseases, or long-term use of corticosteroids or immunosuppressants; Active hepatitis B, active tuberculosis, or other severe or uncontrolled infectious diseases; History of chronic alcohol dependence; Pregnant or lactating women; Legally incompetent, or any medical or ethical reason that may hinder the continuation of the study.