Effects of DL-3-n-butylphthalide on Chemotherapy-Induced Cognitive Impairment (NCT06508671) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Effects of DL-3-n-butylphthalide on Chemotherapy-Induced Cognitive Impairment
100 participantsStarted 2024-07
Plain-language 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 survivors and can persist for years after chemotherapy is discontinued, causing more severe progressive manifestations and placing a heavy burden on families and society. Numerous studies have proposed several potential mechanisms and etiologies for CICI, including direct neurotoxicity, disruption of the blood-brain barrier, reduced hippocampal neurogenesis, white matter abnormalities, secondary neuroinflammatory responses, and increased oxidative stress. At present, there is no clear and effective diagnosis and therapy for CICI, and how to diagnose and treat cognitive impairment caused by chemotherapy effectively is still the focus and difficulty.
Based on the previous consensus on the application of dl-3-n-butylphthalide, butylphthalein can play a neuroprotective role by reducing oxidative stress and inflammatory response, inhibiting neuronal apoptosis, improving mitochondrial function and other mechanisms, and significantly improve the performance of the central nervous system caused by cerebral ischemia and vascular dementia. However, the increase of neuroinflammatory response and oxidative stress is precisely one of the potential mechanisms of CICI pathogenesis. Therefore, based on the above findings, this study hypothesized that dl-3-n-butylphthalide would also have considerable efficacy in the treatment of CICI.
Who can participate
Age range35 Years – 80 Years
SexALL
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Inclusion criteria
✓. 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;
Exclusion criteria
✕. Diagnosed with a cognitively impaired disease, such as Alzheimer's disease;
What they're measuring
1
Mini-mental State Examination (MMSE)
Timeframe: Before chemotherapy,during chemotherapy (12 week after the start of chemotherapy,24 week after the start of chemotherapy),after chemotherapy (12 days after the last chemotherapy)
2
Montreal Cognitive Assessment (MoCA)
Timeframe: Before chemotherapy,during chemotherapy (12 week after the start of chemotherapy,24 week after the start of chemotherapy),after chemotherapy (12 days after the last chemotherapy)
✕. 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)