NCT07550205Not yet recruitingPhase 2/3
Tiaoshen Anti-cancer Protocol and CBT for Insomnia and Survival in Ovarian Cancer
Tiaoshen Anti-cancer Protocol and CBT for Insomnia and Survival in Ovarian Cancer: A Multicenter Randomized Trial
Source: ClinicalTrials.gov · Last updated 24 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 360 (estimated)
- First submitted
- 21 Mar 2026
- Start date
- 1 May 2026
- Primary completion date
- 30 Sept 2029
- Lead sponsor
- Shanghai Municipal Hospital of Traditional Chinese Medicine
- Diseases
- Ovarian cancer
- NCT number
- NCT07550205
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 360
- From 1 May 2026 to the primary completion date, 30 Sept 2029
- 1 site in 1 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
- 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.
Other illness
- 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.
Other
- Pregnant or lactating women.
- Legally incompetent, or any medical or ethical reason that may hinder the continuation of the study.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Hospital of Traditional Chinese Medicine Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.