Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guanzhou, Guangdong, 510000, China
Location status: Recruiting
NCT Number: NCT06576180
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
Interested in participating?
Request Info18 year–80 year
All sexes
Observational
Guanzhou, Guangdong, 510000, China
Location status: Recruiting
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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
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
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
Anti-PD-1 Drugs 200 mg administered by intravenous (IV) infusion on Day 1 of each 21-day cycle
Standard of care
Time frame: 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).
Time frame: Within 30 days after surgery
Defined as the proportion of subjects with ≤10% viable tumor cells in resection specimens to total subjects
Time frame: 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
Time frame: 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
Time frame: Within 30 days after surgery
Defined as the proportion of subjects without viable tumor cells in the resection specimen to the total subjects
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Other
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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