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Could a stroke drug fix chemo brain?

NCT ID NCT07454473

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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
The full record has not been published yet, so there is little to show here.
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This status has not been confirmed recently, so it may be out of date.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 a sublingual tablet (Edaravone and Dexborneol) to treat chemo brain, a common side effect of cancer treatment that causes memory, focus, and thinking problems. About 80 adults who have received chemotherapy and now have cognitive issues will take the tablet. The goal is to see if it improves their thinking and quality of life by reducing brain inflammation and damage.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 80 people

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

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

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

35 to 80 years

Sex

Anyone

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 receiving \*\*monotherapy with any chemotherapeutic agent\*\* (including but not limited to): * \*Alkylating agents\*: Cyclophosphamide, Carmustine, Lomustine, Temozolomide, etc. * \*Antimetabolites\*: 5-Fluorouracil, Methotrexate, Capecitabine, Gemcitabine, etc. * \*Platinum-based drugs\*: Cisplatin, Carboplatin, Oxaliplatin, etc. * \*Taxanes\*: Paclitaxel, Docetaxel, etc. * \*Anthracyclines\*: Doxorubicin, Epirubicin, etc. * \*Other agents\*: Vincristine, Etoposide, Irinotecan, etc. * and\*\* meeting all subconditions\*\*: * No concurrent use of other therapeutic drugs * Histologically confirmed malignant tumor (excluding central nervous system tumors) requiring chemotherapy * Availability of tissue biopsy results 2\. Full comprehension of the study's purpose, potential adverse reactions, and provision of \*\*written informed consent\*\*. 3\. Aged \*\*35-80 years\*\*, fluent in Chinese, cognitively capable of completing questionnaires independently, \*\*with caregiver assistance\*\* for questionnaire completion. 4\. Initial complaint of cognitive impairment (memory and/or other domains) \*\*occurring ≥3 months before chemotherapy initiation\*\*. 5\. Completion of cancer treatment with \*\*curative intent\*\* (excluding post-chemotherapy endocrine therapy). 6\. \*\*Clinical Dementia Rating (CDR)\*\* global score of \*\*0.5-2\*\* (indicating questionable to moderate cognitive impairment) and \*\*no significant visual or auditory deficits Exclusion Criteria: * 1\. Established diagnosis of \*\*cognitive impairment disorders\*\* (e.g., Alzheimer's disease, frontotemporal dementia, Parkinson's dementia). 2\. Primary or metastatic \*\*central nervous system malignancies\*\*. 3. History of \*\*brain metastases or other intracranial tumors\*\*. 4. Severe \*\*head trauma\*\* or stroke with significant residual deficits (\*\*Activities of Daily Living \[ADL\] score \< 60\*\*). 5\. Poorly controlled \*\*epilepsy\*\* or other seizure disorders. 6. \*\*Contraindications to MRI\*\* (e.g., claustrophobia, cardiac pacemakers, metal implants) - \*excluded from fMRI testing only\*; otherwise eligible participants may enroll without fMRI. 7\. Current use of \*\*cognition-affecting medications\*\*, including but not limited to: * \*Cholinesterase inhibitors\*: Donepezil, Rivastigmine, Galantamine * \*NMDA receptor antagonists\*: Memantine * \*Other agents\*: Sodium oligomannate, Ginkgo biloba extract, Oxiracetam, Piracetam, Nicergoline, Lecanemab, Aducanumab 8. \*\*Pregnancy\*\*, lactation, or plans for pregnancy. 9. Active \*\*neurological or untreated/unremitted psychiatric disorders\*\* (e.g., active major depressive disorder per DSM-5; \*stable treated depression permitted\*). 10\. \*\*Alcohol/substance abuse or dependence\*\* within the past 2 years. 11. \*\*Clinically significant systemic diseases/unstable medical conditions\*\*, including: * Cardiac: Myocardial infarction (≤1 year), unstable angina, congestive heart failure, or clinically abnormal ECG * Pulmonary: Acute asthma exacerbation, pulmonary embolism * Gastrointestinal: Active bleeding, inflammatory bowel disease * Hepatic: Cirrhosis or ALT/AST \>2× ULN * Renal: Serum creatinine \>1.5× ULN 12. Use of \*\*non-study cognition-enhancing drugs\*\* within 4 weeks prior to enrollment. 13\. Use of edaravone dexborneol within 30 days prior to enrollment.

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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

  • The First Affiliated Hospital of China Medical University

    RECRUITING

    Shenyang, Liaoning, 110000, China

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