Chemotherapy-Related Cognitive ImpairmentPhase 4NCT06508671
Effects of DL-3-n-butylphthalide on Chemotherapy-Induced Cognitive Impairment
A Phase 4 study testing DL-3-n-butylphthalide and Empty Medication Capsules in people with Chemotherapy-Related Cognitive Impairment and DL-3-n-butylphthalide, run by First Hospital of China Medical University.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Chemotherapy-Related Cognitive Impairment, DL-3-n-butylphthalide
- What is being tested?
- DL-3-n-butylphthalide and Empty Medication Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jul 2024to Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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;
Who cannot join
- 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;
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- 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.
About this study
Official title: Effects of DL-3-n-butylphthalide on Chemotherapy-Induced Cognitive Impairment (NBP CICI)：a Prospective, Randomized, Double Blinded, Multicenter, Placebo Controlled Study
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.
- Being tested
- DL-3-n-butylphthalide, Empty Medication Capsules
- Medical subject headings
- Chemotherapy-Related Cognitive Impairment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DL-3-n-butylphthalideDrug
Take butylphthalide soft capsules orally
Empty Medication CapsulesDrug
Take empty medication capsules orally
| Study group | Role | What they receive |
|---|---|---|
| dl-3-n-butylphthalide | Experimental | Take 200 mg butylphthalide soft capsules (NBP) orally three times a day for 24 weeks Receives: Drug: DL-3-n-butylphthalide |
| placebo | Placebo comparator | Take 200 mg placebo of the same appearance with NBP orally three times a day for 24 weeks Receives: Drug: Empty Medication Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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 (9)
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.
Measured: 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)
Clinical Dementia Rating(CDR)
CDR is a multidimensional dementia severity scale, scored on a 0-3 scale, with higher scores indicating poorer functioning.
Measured: 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)
Activities of Daily Living (ADL)
ADL are used to assess a patient's ability to perform daily living.
Measured: 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)
Hamilton Depression Scale(HAMD)
HAMD is used to assess the severity and progression of depressive symptoms.
Measured: 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)
Hamilton Anxiety Scale(HAMA)
HAMA is mainly used to assess the severity of neurosis and other anxiety symptoms in patients.
Measured: 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)
Self-rating depression scale(SDS)
SDS is mainly suitable for adults with depressive symptoms, and can intuitively reflect the subjective feelings of depressed patients.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study startJul 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-Related Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Hospital of China Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chuansheng Zhao, First Hospital of China Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06508671
- Sponsor's protocol ID
- NBP-CICI-202405
- Status last verified
- Jul 2024
- First submitted
- 14 Jul 2024
- Last updated
- 18 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of DL-3-n-butylphthalide on Chemotherapy-Induced Cognitive Impairment (NBP CICI)：a Prospective, Randomized, Double Blinded, Multicenter, Placebo Controlled Study
- ClinicalTrials.gov ID
- NCT06508671
- Acronym / sponsor ID
- NBP-CICI-202405
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- First Hospital of China Medical UniversityUniversity, hospital or other
- Study start
- Jul 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 18 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dl-3-n-butylphthalide | Experimental | Drug: DL-3-n-butylphthalideTake 200 mg butylphthalide soft capsules (NBP) orally three times a day for 24 weeks |
| placebo | Placebo comparator | Drug: Empty Medication CapsulesTake 200 mg placebo of the same appearance with NBP orally three times a day for 24 weeks |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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;
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DL-3-n-butylphthalideTake butylphthalide soft capsules orally | Drug | dl-3-n-butylphthalide |
| Empty Medication CapsulesTake empty medication capsules orally | Drug | placebo |
Primary outcome
Mini-mental State Examination (MMSE)
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)
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.
Montreal Cognitive Assessment (MoCA)
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)
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.
9 secondary outcomes
Clinician's Interview-based Impression of Change plus caregiver input(CIBIC-plus)
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)
Clinical Dementia Rating(CDR)
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)
Activities of Daily Living (ADL)
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)
Hamilton Depression Scale(HAMD)
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)
Hamilton Anxiety Scale(HAMA)
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)
Self-rating depression scale(SDS)
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)
self-rating anxiety scale(SAS)
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)
Functional Magnetic Resonance Imaging(fMRI)
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)
Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing DL-3-n-butylphthalide and Empty Medication Capsules in people with Chemotherapy-Related Cognitive Impairment and DL-3-n-butylphthalide, run by First Hospital of China Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mini-mental State Examination (MMSE) (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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2024.