Chemo BrainPhase 4EDS-CICINCT07454473
Edaravone and Dexborneol Sublingual Tablet for Treating Chemotherapy- Induced Cognitive Impairment Study
A Phase 4 study testing Edaravone Dexborneol in people with Chemo Brain, run by Chuansheng Zhao at 1 site in China.
Trial summary
Chemotherapy-induced cognitive impairment (CICI), also known as "chemobrain," is a range of neurocognitive deficits experienced during and after cancer chemotherapy. It is also one of the significant factors affecting the quality of life of cancer patients. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Chemo Brain
- What is being tested?
- Edaravone Dexborneol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 2 Mar 2026to 31 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- *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
Who cannot join
- 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
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- *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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, 110000
About this study
Chemotherapy-induced cognitive impairment (CICI), also known as "chemobrain," is a range of neurocognitive deficits experienced during and after cancer chemotherapy. It is also one of the significant factors affecting the quality of life of cancer patients. Due to patients' subjective feelings, the definition of cognitive impairment, the variety of testing scales, and the lack of pre-chemotherapy cognitive function measurements, it is difficult to determine its incidence rate. Consequently, the diagnosis and treatment of this condition are delayed. Existing studies report a high incidence of CICI, affecting 17% to 78% of survivors, and it may persist for years after chemotherapy cessation, leading to more severe progressive manifestations. Its main clinical presentations include deficits in attention, memory, reasoning, multi-tasking ability, decision-making ability, as well as learning and language impairments. These significantly affect patients' functional independence, imposing a heavy burden on families and society. Numerous studies have proposed several potential mechanisms and etiologies for CICI, including direct neurotoxicity of chemotherapeutic drugs, blood-brain barrier disruption, reduced hippocampal neurogenesis, white matter abnormalities, secondary neuroinflammatory responses, and increased oxidative stress. However, the exact underlying mechanisms remain unclear. Currently, there is no clear and effective diagnosis or treatment method for CICI. How to effectively diagnose and treat cognitive impairment caused by chemobrain remains a key focus and challenge in current research.
Previous studies indicate that in the treatment of ischemic stroke, Edaravone exerts its effects by scavenging oxygen free radicals, reducing inflammatory responses, mitigating neuronal and endothelial cell damage, and inhibiting excitatory neurotoxicity. It also inhibits neuronal lipid peroxidation and alleviates brain tissue damage and cerebral edema caused by cerebral ischemia and hypoxia. Dexborneol, as a bicyclic monoterpenoid compound, can also inhibit inflammatory responses, protect blood-brain barrier permeability, and reduce cell apoptosis. The combination of these two active ingredients can exert multiple mechanisms of action, including free radical scavenging, anti-inflammation, and blood-brain barrier protection, significantly reducing neuronal damage caused by acute ischemic stroke and exerting neuroprotective effects. Clinically, it effectively reduces infarct volume and improves neurological function.
Read more
The aforementioned pathogenesis of CICI precisely involves increased neuroinflammation and oxidative stress, as well as damage to the blood-brain barrier. Furthermore, the sublingual tablet dosage form offers advantages in convenience compared to injections. Based on this, we hypothesize that Edaravone Borneol sublingual tablets may also have considerable efficacy in treating chemotherapy-related cognitive impairment.
This study addresses a clinical cross-disciplinary event in neurology and oncology. It aims to evaluate the efficacy of Edaravone Dexborneol sublingual tablets for CICI and conduct preliminary exploration of early diagnostic biomarkers for CICI by collecting clinical patient imaging data, blood samples, and neuropsychological scale results. This will ultimately help optimize chemotherapy regimens to the greatest extent.
- Conditions
- Chemo Brain
- Being tested
- Edaravone Dexborneol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Edaravone DexborneolDrug
CICI
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | EDS tablet Receives: Drug: Edaravone Dexborneol |
| Control group | Placebo comparator | placebo Receives: Drug: Edaravone Dexborneol |
What is being measured
The primary outcome is the main question the study is designed to answer.
FACT-Cog score
Measured: From trial enrollment until the completion of the 14-week treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start2 Mar 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemo BrainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chuansheng Zhao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chuansheng Zhao, First Hospital of China Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07454473
- Sponsor's protocol ID
- EDS-CICI-2025
- Acronym
- EDS-CICI
- Status last verified
- Mar 2026
- First submitted
- 2 Mar 2026
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Edaravone and Dexborneol Sublingual Tablet for Treating Chemotherapy- Induced Cognitive Impairment Study
- ClinicalTrials.gov ID
- NCT07454473
- Acronym / sponsor ID
- EDS-CICI / EDS-CICI-2025
- Conditions
- Chemo Brain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Chuansheng ZhaoUniversity, hospital or other
- Study start
- 2 Mar 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 6 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chemotherapy-induced cognitive impairment (CICI), also known as "chemobrain," is a range of neurocognitive deficits experienced during and after cancer chemotherapy. It is also one of the significant factors affecting the quality of life of cancer patients. Due to patients' subjective feelings, the definition of cognitive impairment, the variety of testing scales, and the lack of pre-chemotherapy cognitive function measurements, it is difficult to determine its incidence rate. Consequently, the diagnosis and treatment of this condition are delayed. Existing studies report a high incidence of CICI, affecting 17% to 78% of survivors, and it may persist for years after chemotherapy cessation, leading to more severe progressive manifestations. Its main clinical presentations include deficits in attention, memory, reasoning, multi-tasking ability, decision-making ability, as well as learning and language impairments. These significantly affect patients' functional independence, imposing a heavy burden on families and society. Numerous studies have proposed several potential mechanisms and etiologies for CICI, including direct neurotoxicity of chemotherapeutic drugs, blood-brain barrier disruption, reduced hippocampal neurogenesis, white matter abnormalities, secondary neuroinflammatory responses, and increased oxidative stress. However, the exact underlying mechanisms remain unclear. Currently, there is no clear and effective diagnosis or treatment method for CICI. How to effectively diagnose and treat cognitive impairment caused by chemobrain remains a key focus and challenge in current research.
Previous studies indicate that in the treatment of ischemic stroke, Edaravone exerts its effects by scavenging oxygen free radicals, reducing inflammatory responses, mitigating neuronal and endothelial cell damage, and inhibiting excitatory neurotoxicity. It also inhibits neuronal lipid peroxidation and alleviates brain tissue damage and cerebral edema caused by cerebral ischemia and hypoxia. Dexborneol, as a bicyclic monoterpenoid compound, can also inhibit inflammatory responses, protect blood-brain barrier permeability, and reduce cell apoptosis. The combination of these two active ingredients can exert multiple mechanisms of action, including free radical scavenging, anti-inflammation, and blood-brain barrier protection, significantly reducing neuronal damage caused by acute ischemic stroke and exerting neuroprotective effects. Clinically, it effectively reduces infarct volume and improves neurological function.
The aforementioned pathogenesis of CICI precisely involves increased neuroinflammation and oxidative stress, as well as damage to the blood-brain barrier. Furthermore, the sublingual tablet dosage form offers advantages in convenience compared to injections. Based on this, we hypothesize that Edaravone Borneol sublingual tablets may also have considerable efficacy in treating chemotherapy-related cognitive impairment.
This study addresses a clinical cross-disciplinary event in neurology and oncology. It aims to evaluate the efficacy of Edaravone Dexborneol sublingual tablets for CICI and conduct preliminary exploration of early diagnostic biomarkers for CICI by collecting clinical patient imaging data, blood samples, and neuropsychological scale results. This will ultimately help optimize chemotherapy regimens to the greatest extent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: Edaravone DexborneolEDS tablet |
| Control group | Placebo comparator | Drug: Edaravone Dexborneolplacebo |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
- *Cholinesterase inhibitors*: Donepezil, Rivastigmine, Galantamine
- *NMDA receptor antagonists*: Memantine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Edaravone DexborneolCICI | Drug | Control group, Treatment group |
Primary outcome
FACT-Cog score
Time frame: From trial enrollment until the completion of the 14-week treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Edaravone Dexborneol in people with Chemo Brain, run by Chuansheng Zhao at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact chuansheng zhao (+86-13940369251, cszhao@cmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FACT-Cog score (time frame: From trial enrollment until the completion of the 14-week treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.