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Can ancient herbs and modern therapy help ovarian cancer patients sleep better and live longer?

NCT ID NCT07550205

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
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Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 360 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Sep 2029

An estimate. End dates often move.

Lead sponsor

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

18 to 80 years

Sex

Female participants only

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Shanghai Hospital of Traditional Chinese Medicine

    Shanghai, Shanghai Municipality, 200071, China

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Other studies related to the condition(s) this trial covers.