Effects of neoadjuvant therapy on cognitive function in head and neck cancer patients
Effects of Neoadjuvant Therapy With Carboplatin, Paclitaxel Combined With Anti-PD-1 Drugs on Cognitive Function in Patients With Resectable Head and Neck Squamous Cell Carcinoma: a Prospective Cohort Study
This study is testing how treatment with certain cancer drugs affects thinking and memory in patients with head and neck cancer before and after their surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 306 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Guanzhou, Guangdong) |
| Trial ID | NCT06576180 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate how neoadjuvant therapy using carboplatin, paclitaxel, and anti-PD-1 drugs impacts cognitive function in patients diagnosed with resectable head and neck squamous cell carcinoma. Participants will be monitored for cognitive changes before and after treatment, providing valuable insights into the effects of these therapies. The study will include a cohort of patients who are scheduled for surgical intervention, allowing for a comprehensive assessment of cognitive outcomes related to cancer treatment.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with stage I-IVA head and neck squamous cell carcinoma who are planning to undergo surgical treatment.
Not a fit: Patients with a history of neurological diseases or those at high risk for cognitive decline may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify cognitive risks associated with neoadjuvant therapies, leading to improved patient management and care strategies.
How similar studies have performed: While there have been studies on cognitive effects of cancer treatments, this specific combination of therapies in head and neck cancer is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1: The patient was diagnosed with head and neck squamous cell carcinoma (stage I-IVA), without treatment, and planned to undergo only surgical treatment or surgical treatment + chemotherapy and immunotherapy. 2: Can speak Chinese and have certain reading and writing skills 3: Healthy group: Dental inpatients with non-oral cancer, no history of neurological diseases, and no previous history of malignant tumors Exclusion Criteria: * 1: Brain tumor, brain injury, or stroke at baseline or during follow-up 2: A history of stroke or a medical condition that puts you at high risk for future dementia or recurrence 3: Active mental illness or active narcotic drug use, including using alcohol more than 4 times per day or more than 4 times per week 4: Neurocognitive diseases that affect cognitive function, such as Parkinson's disease or Alzheimer's disease 5: History of drug-associated encephalopathy or brain infection 6: Patients who change their treatment plan during treatment 7: Patients who are currently taking or have taken antidepressants
Where this trial is running
Guanzhou, Guangdong
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University — Guanzhou, Guangdong, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.