Head and Neck Squamous Cell Carcinoma
Conditions
Brief summary
The goal of this observational study is to learn about the 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
Interventions
Carboplatin (IV), AUC=5，administered by intravenous (IV) infusion on Day 1 of each 21-day cycle
Paclitaxel 260mg/m2 administered by intravenous (IV) infusion on Day 1 of each 21-day cycle
DRUGAnti-PD-1 Drugs
Anti-PD-1 Drugs 200 mg administered by intravenous (IV) infusion on Day 1 of each 21-day cycle
PROCEDURESurgical resection
Standard of care
Sponsors
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| cognitive adverse events, CoAE | Baseline, 9 weeks, 6 months, 12 months | Scores on two or more of the neuropsychological battery tests (NBT) of the HVLT-R, COWA, and TMT are 1.5 SD below the standard mean (or the mean score of an appropriate control group), Or a single test score that is 2.0 SD below the mean can be marked as an objective cognitive adverse event (CoAE). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major pathological response rate | Within 30 days after surgery | Defined as the proportion of subjects with ≤10% viable tumor cells in resection specimens to total subjects |
| Montreal Cognitive Assessment, MoCA | The total score is obtained by adding up the scores of each item, and the full score is 30 points. The application results of the original English version of the scale designer show that if the number of years of education is ≤12 years, 1 point is added, | Baseline, 9 weeks, 6 months, 12 months |
| perceived cognitive decline events , PCDE | 1/2 standard deviation (SD) of the PCI score in the baseline healthy population is defined as a minimal clinically important difference (MCID), and a change in PCI score that exceeds the MCID in each test will be labeled as PCDE. | Baseline, 9 weeks, 6 months, 12 months |
| complete pathological response rate | Within 30 days after surgery | Defined as the proportion of subjects without viable tumor cells in the resection specimen to the total subjects |
Countries
China
Outcome results
None listed