Sublingual edaravone–dexborneol for chemo-related cognitive problems.

Edaravone and Dexborneol Sublingual Tablet for Treating Chemotherapy- Induced Cognitive Impairment Study

This trial will test whether a sublingual tablet combining edaravone and dexborneol can improve memory, attention, and thinking in adults aged 35–80 who have cognitive problems after chemotherapy.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 35 Years to 80 Years
• Sex: All
• Sponsor: First Hospital of China Medical University (other)
• Drugs / interventions: Lecanemab, Aducanumab, chemotherapy, Methotrexate, Cyclophosphamide, Doxorubicin
• Locations: 1 site (Shenyang, Liaoning)
• Trial ID: NCT07454473 on ClinicalTrials.gov

What this trial studies

This phase 4, single-site interventional trial administers a sublingual combination of edaravone and dexborneol to patients who develop chemotherapy-induced cognitive impairment while receiving single-agent chemotherapy. Participants are adults aged 35–80 with histologically confirmed non‑CNS malignancies who can complete cognitive questionnaires in Chinese and provide biopsy results. The protocol excludes people on concurrent therapeutic drugs or with central nervous system tumors and requires written informed consent. Outcomes focus on changes in attention, memory, and executive function over the treatment period to see if the medication improves everyday thinking and functioning.

Who should consider this trial

Good fit: Ideal candidates are Chinese-speaking adults 35–80 years old with a histologically confirmed non‑CNS cancer receiving single-agent chemotherapy, able to complete cognitive questionnaires, and willing to provide informed consent and biopsy results.

Not a fit: Patients with central nervous system tumors, those receiving combination chemotherapy or other concurrent therapeutic drugs, people outside the 35–80 age range, or those unable to complete the required questionnaires are unlikely to benefit from enrollment.

Why it matters

Potential benefit: If effective, the treatment could reduce memory and attention problems after chemotherapy and improve patients' daily functioning and quality of life.

How similar studies have performed: While edaravone and dexborneol have shown neuroprotective effects in stroke and preclinical models, their use specifically for chemotherapy-related cognitive impairment is largely novel and not yet established.

Eligibility criteria

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.

Where this trial is running

Shenyang, Liaoning

• The First Affiliated Hospital of China Medical University — Shenyang, Liaoning, China (RECRUITING)

Study contacts

• Study coordinator: chuansheng zhao

Conditions: Chemo Brain