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Not yet recruitingNCT06508671Updated Jul 18, 2024

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

A Phase 4 interventional study of DL-3-n-butylphthalide and Empty Medication Capsules in Chemotherapy-Related Cognitive Impairment and DL-3-n-butylphthalide, sponsored by First Hospital of China Medical University. Not yet recruiting. Open to participants aged 35 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-07-18.

Sponsored by First Hospital of China Medical University · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 4
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
35 Years to 80 Years
Sex
All
01

Study 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.

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Conditions studied

  • Chemotherapy-Related Cognitive Impairment
  • DL-3-n-butylphthalide
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In context

Chemotherapy-Related Cognitive Impairment

37 studies on the registry are indexed under Chemotherapy-Related Cognitive Impairment; 17 are open to participants now.

This study's planned enrollment of 100 is above the median of 80 across 29 interventional studies indexed under Chemotherapy-Related Cognitive Impairment.

Browse Chemotherapy-Related Cognitive Impairment studies →

Lead sponsor

First Hospital of China Medical University is the lead sponsor of 59 studies on the registry; 32 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
35 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    dl-3-n-butylphthalide

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

    Drug: DL-3-n-butylphthalide

  • Placebo comparator
    placebo

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

    Drug: Empty Medication Capsules

Interventions

  • DrugDL-3-n-butylphthalide

    Take butylphthalide soft capsules orally

  • DrugEmpty Medication Capsules

    Take empty medication capsules orally

06

What researchers measure

Primary outcomes

  1. 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: 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)

    Patients' cognitive domains were assessed with 11 test items in eight cognitive domains: attention and concentration, executive function, memory, language, visual structure skills, abstract thinking, computation, and orientation. Total score 30, ≥26 normal. Combined with the basic characteristics of patients, preoperative and post-chemotherapy assessment was performed to determine the status of patients with mild cognitive impairment.

    Time frame: 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)

Secondary outcomes

  1. Clinician's Interview-based Impression of Change plus caregiver input(CIBIC-plus)

    CIBIC-plus reflects the clinical improvement of the subject through interviews with the subject and their caregivers.

    Time frame: 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. Clinical Dementia Rating(CDR)

    CDR is a multidimensional dementia severity scale, scored on a 0-3 scale, with higher scores indicating poorer functioning.

    Time frame: 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)

  3. Activities of Daily Living (ADL)

    ADL are used to assess a patient's ability to perform daily living.

    Time frame: 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)

  4. Hamilton Depression Scale(HAMD)

    HAMD is used to assess the severity and progression of depressive symptoms.

    Time frame: 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)

  5. Hamilton Anxiety Scale(HAMA)

    HAMA is mainly used to assess the severity of neurosis and other anxiety symptoms in patients.

    Time frame: 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)

  6. Self-rating depression scale(SDS)

    SDS is mainly suitable for adults with depressive symptoms, and can intuitively reflect the subjective feelings of depressed patients.

    Time frame: 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)

  7. self-rating anxiety scale(SAS)

    SAS is mainly suitable for adults with anxiety symptoms and can directly reflect the subjective feelings of patients with anxiety.

    Time frame: 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)

  8. Functional Magnetic Resonance Imaging(fMRI)

    fMRI is a research method that stimulates specific senses to cause neural activity (functional area activation) in the corresponding parts of the cerebral cortex and shows it through magnetic resonance images.

    Time frame: 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)

  9. Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

    PRO-CTCAE is a tool used to document self-reported adverse events and their severity on a 5-point scale. In our trial, we plan to evaluate 12 symptoms selected from the original PRO-CTCAE scale, specifically decreased appetite, nausea, vomiting, heartburn, bloating, constipation, diarrhea, abdominal pain, insomnia, fatigue, headache, and dizziness.

    Time frame: 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)

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06508671
Lead sponsor
First Hospital of China Medical University
Responsible party
Chuansheng Zhao (Professor, First Hospital of China Medical University) — Principal investigator
First posted
Jul 18, 2024
Start date
Jul 2024 (estimated)
Primary completion
Dec 2025 (estimated)
Completion
Dec 2026 (estimated)
Last update
Jul 18, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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