Can ancient herbs and modern therapy help ovarian cancer patients sleep better and live longer?
NCT ID NCT07550205
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a traditional Chinese herbal formula (Tiaoshen Anti-cancer granules) combined with cognitive behavioral therapy for insomnia (CBT-I) can improve sleep and possibly extend survival in 360 women with advanced ovarian cancer. Participants will receive either the herbal granules or a placebo, plus CBT-I, for 18 weeks. The main goals are to see if sleep quality improves and if cancer progression is delayed.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Tiaoshen Anti-cancer herbal formula granules (Astragalus, Paris Polyphylla, Spina Date Seed, Curcuma Aromatic)
- What this could lead to
- If it works, this could offer a way to improve sleep and quality of life for ovarian cancer patients, and possibly help them live longer without their cancer getting worse.
- What could go wrong
- This is an early-stage trial (Phase 2/3) with 360 participants, so results may not apply to everyone. The herbal formula's benefits are unproven, and it may not improve survival or sleep more than placebo.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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About 360 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patients aged 18 to 80 years (inclusive). 2. Performance status (PS) score of 0-2. 3. 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. 4. 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. 5. 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). 6. 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). 7. Voluntarily sign the informed consent form, agree to receive the study treatment, and able to independently complete a sleep diary. Exclusion Criteria: 1. Previous systematic treatment with Cognitive Behavioral Therapy for Insomnia. 2. 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. 3. Pregnant or lactating women. 4. Comorbid severe primary diseases of the cardiovascular, cerebrovascular, pulmonary, hepatic, renal, or hematopoietic systems. 5. Language barriers that would prevent completion of assessments or therapy. 6. Comorbid autoimmune diseases, congenital or acquired immunodeficiency diseases, hematological diseases, or long-term use of corticosteroids or immunosuppressants. 7. Active hepatitis B, active tuberculosis, or other severe or uncontrolled infectious diseases. 8. History of chronic alcohol dependence. 9. Concurrent other primary malignant tumors (except for cured non-melanoma skin cancer, carcinoma in situ of the cervix, etc.). 10. Participation in any other clinical trial within 3 months prior to enrollment. 11. Legally incompetent, or any medical or ethical reason that may hinder the continuation of the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Shanghai Hospital of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 200071, China
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