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

NCT ID: NCT06508671

Last Updated: 2024-07-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-31
• Study Completion Date: 2026-12-31

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 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.

Conditions

Chemotherapy-Related Cognitive Impairment; DL-3-n-butylphthalide

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

dl-3-n-butylphthalide

Take 200 mg butylphthalide soft capsules (NBP) orally three times a day for 24 weeks

Group Type: EXPERIMENTAL

DL-3-n-butylphthalide

Intervention Type: DRUG

Take butylphthalide soft capsules orally

placebo

Take 200 mg placebo of the same appearance with NBP orally three times a day for 24 weeks

Group Type: PLACEBO_COMPARATOR

Empty Medication Capsules

Intervention Type: DRUG

Take empty medication capsules orally

Interventions

DL-3-n-butylphthalide

Take butylphthalide soft capsules orally

Intervention Type: DRUG

Empty Medication Capsules

Take empty medication capsules orally

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. 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)

2. Sign the informed consent and understand the purpose and significance of the study;

3. Aged between 35 and 80 years old;

4. Ability to complete the questionnaire on their own or with assistance;

5. Complaints of cognitive impairment involving memory and/or other cognitive areas lasting for at least 3 months;

6. Cancer treatment has been completed and is considered curable, with the exception of endocrine therapy after chemotherapy;

7. MMSE score: 18-26;

8. Clinical Dementia Rating (CDR) score: 0.5-2;

9. Fluent in Chinese;

10. No visual or hearing impairment;

11. Did not participate in another intervention study within 6 months prior to commencing this study;

Exclusion Criteria

1. Diagnosed with a cognitively impaired disease, such as Alzheimer's disease;

2. 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;

3. Take medications that may affect cognitive function

4. History of brain metastases or other brain tumors;

5. History of stroke or severe head trauma;

6. History of epilepsy or other seizures;

7. Pregnant or considering becoming pregnant;

8. 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)

9. Any history of alcohol or drug abuse or dependence within the past 2 years;

10. 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;

11. Have taken any non-research drugs to improve cognitive function within 4 weeks prior to enrollment;

12. Have taken butylphthalein in the past 30 days.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Hospital of China Medical University

OTHER

Sponsor Role: lead

Responsible Party

Chuansheng Zhao

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

NBP-CICI-202405

Identifier Type: -

Identifier Source: org_study_id