Status:
NOT_YET_RECRUITING
Effects of DL-3-n-butylphthalide on Chemotherapy-Induced Cognitive Impairment
Lead Sponsor:
First Hospital of China Medical University
Conditions:
Chemotherapy-Related Cognitive Impairment
DL-3-n-butylphthalide
Eligibility:
All Genders
35-80 years
Phase:
PHASE4
Brief Summary
Chemotherapy-related cognitive Impairment (CICI) is a series of neurocognitive deficits experienced during and after cancer chemotherapy. Studies have reported that CICI affects 25% to 75% of survivor...
Eligibility Criteria
Inclusion
- Treatment with paclitaxel drugs (such as paclitaxel/docetaxel/albumin-based paclitaxel, etc.) or platinum-based chemotherapy (cisplatin), and not combined with other chemotherapy drugs; (Cancer type is not limited)
- Sign the informed consent and understand the purpose and significance of the study;
- Aged between 35 and 80 years old;
- Ability to complete the questionnaire on their own or with assistance;
- Complaints of cognitive impairment involving memory and/or other cognitive areas lasting for at least 3 months;
- Cancer treatment has been completed and is considered curable, with the exception of endocrine therapy after chemotherapy;
- MMSE score: 18-26;
- Clinical Dementia Rating (CDR) score: 0.5-2;
- Fluent in Chinese;
- No visual or hearing impairment;
- Did not participate in another intervention study within 6 months prior to commencing this study;
Exclusion
- Diagnosed with a cognitively impaired disease, such as Alzheimer's disease;
- Patients will be excluded from fMRI testing if they are claustrophobic, have MRI contraindications such as pacemakers or metal implants, and patients who did not undergo fMRI testing may still participate in clinical trials if all other enrollment criteria are met;
- Take medications that may affect cognitive function
- History of brain metastases or other brain tumors;
- History of stroke or severe head trauma;
- History of epilepsy or other seizures;
- Pregnant or considering becoming pregnant;
- Any active nervous system or untreated/unremitted mental disorder (such as active major depressive disorder or other major mental disorder described in the DSM-5, allowing treatment of depression if treatment is stable)
- Any history of alcohol or drug abuse or dependence within the past 2 years;
- Any major systemic disease or unstable medical condition that may cause difficulty in complying with the protocol, including: a history of myocardial infarction or instability in the past year, serious cardiovascular disease (including angina or congestive heart failure with resting symptoms, or clinically significant abnormalities in the electrocardiogram), clinically significant and/or unstable lung, gastrointestinal, liver or kidney disease;
- Have taken any non-research drugs to improve cognitive function within 4 weeks prior to enrollment;
- Have taken butylphthalein in the past 30 days.
Key Trial Info
Start Date :
July 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06508671
Start Date
July 1 2024
End Date
December 1 2026
Last Update
July 18 2024
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