Effects of DL-3-n-butylphthalide on Chemotherapy-Induced Cognitive Impairment

ConditionsChemotherapy-Related Cognitive Impairment DL-3-n-butylphthalide

Trial statusNot yet recruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age35-80

SponsorFirst Hospital of China Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

DL-3-n-butylphthalide
Drug
Take butylphthalide soft capsules orally
Empty Medication Capsules
Drug
Take empty medication capsules orally

Treatment groups

100 Participants

are divided into 2 treatment groups

Group A: dl-3-n-butylphthalideExperimental treatment 1 intervention

Group B: placeboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Mini-mental State Examination (MMSE)

The scale ranges from 0 to 30 points. Test scores are closely related to literacy level, and the normal cut-off values are: illiterate \>17 points, primary \>20 points, junior high school and above \>24 points. Combined with the basic characteristics of patients, preoperative and post-chemotherapy assessment was performed to determine the dementia status of patients.

Time frame