๐ฌIn plain words
What the trial is, and whether it could suit you
Chemotherapy-induced cognitive impairment (CICI), also known as "chemobrain," is a range of neurocognitive deficits experienced during and after cancer chemotherapy. It is also one of the significant factors affecting the quality of life of cancer patients. Due to patients' subjective feelings, the definition of cognitive impairment, the variety of testing scales, and the lack of pre-chemotherapy cognitive function measurements, it is difficult to determine its incidence rate. Consequently, the diagnosis and treatment of this condition are delayed. Existing studies report a high incidence of CICI, affecting 17% to 78% of survivors, and it may persist for years after chemotherapy cessation, leading to more severe progressive manifestations. Its main clinical presentations include deficits in attention, memory, reasoning, multi-tasking ability, decision-making ability, as well as learning
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
* 1\. Patients receiving \*\*monotherapy with any chemotherapeutic agent\*\* (including but not limited to):
* \*Alkylating agents\*: Cyclophosphamide, Carmustine, Lomustine, Temozolomide, etc.
* \*Antimetabolites\*: 5-Fluorouracil, Methotrexate, Capecitabine, Gemcitabine, etc.
* \*Platinum-based drugs\*: Cisplatin, Carboplatin, Oxaliplatin, etc.
* \*Taxanes\*: Paclitaxel, Docetaxel, etc.
* \*Anthracyclines\*: Doxorubicin, Epirubicin, etc.
* \*Other agents\*: Vincristine, Etoposide, Irinotecan, etc.
* and\*\* meeting all subconditions\*\*:
* No concurrent use of other therapeutic drugs
* Histologically confirmed malignant tumor (excluding central nervous system tumors) requiring chemotherapy
* Availability of tissue biopsy results
2\. Full comprehension of the study's purpose, potential adverse reactions, and provision of \*\*written informed consent\*\*.
3\. Aged \*\*35-80 years\*\*, fluent in Chinese, cognitively capable of completing questionnaires independently, \*\*with caregiver assistance\*\* for questionnaire completion.
4\. Initial complaint of cognitive impairment (memory and/or other domains) \*\*occurring โฅ3 months before chemotherapy initiation\*\*.
5\. Completion of cancer treatment with \*\*curative intent\*\* (excluding post-chemotherapy endocrine therapy).
6\. \*\*Clinical Dementia Rating (CDR)\*\* global score of \*\*0.5-2\*\* (indicating questionable to moderate cognitive impairment) and \*\*no significant visual or auditory deficits
Exclusion Criteria:
* 1\. Established diagnosis of \*\*cognitive impairment disorders\*\* (e.g., Alzheimer's disease, frontotemporal dementia, Parkinson's dementia).
2\. Primary or metastatic \*\*central nervous system malignancies\*\*. 3. History of \*\*brain metastases or other intracranial tumors\*\*. 4. Severe \*\*head trauma\*\* or stroke with significant residual deficits (\*\*Activities of Daily Living \[ADL\] score \< 60\*\*).
5\. Poorly controlled \*\*epilepsy\*\* or other seizure disorders. 6. \*\*Contraindications to MRI\*\* (e.g., claustrophobia, cardiac pacemakers, metal implants) - \*excluded from fMRI testing only\*; otherwise eligible participants may enroll without fMRI.
7\. Current use of \*\*cognition-affecting medications\*\*, including but not limited to:
* \*Cholinesterase inhibitors\*: Donepezil, Rivastigmine, Galantamine
* \*NMDA receptor antagonists\*: Memantine
* \*Other agents\*: Sodium oligomannate, Ginkgo biloba extract, Oxiracetam, Piracetam, Nicergoline, Lecanemab, Aducanumab 8. \*\*Pregnancy\*\*, lactation, or plans for pregnancy. 9. Active \*\*neurological or untreated/unremitted psychiatric disorders\*\* (e.g., active major depressive disorder per DSM-5; \*stable treated depression permitted\*).
10\. \*\*Alcohol/substance abuse or dependence\*\* within the past 2 years. 11. \*\*Clinically significant systemic diseases/unstable medical conditions\*\*, including:
* Cardiac: Myocardial infarction (โค1 year), unstable angina, congestive heart failure, or clinically abnormal ECG
* Pulmonary: Acute asthma exacerbation, pulmonary embolism
* Gastrointestinal: Active bleeding, inflammatory bowel disease
* Hepatic: Cirrhosis or ALT/AST \>2ร ULN
* Renal: Serum creatinine \>1.5ร ULN 12. Use of \*\*non-study cognition-enhancing drugs\*\* within 4 weeks prior to enrollment.
13\. Use of edaravone dexborneol within 30 days prior to enrollment.