Clinical trial NCT06576180: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Head and Neck Squamous Cell Carcinoma
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2024-08-28
Enrollment: 306
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients were diagnosed with head and neck squamous cell carcinoma (stages I-IV) and did not receive treatment. They planned to receive only surgical treatment or combined surgical treatment + chemotherapy and immunotherapy. They were divided into two groups, and the participating groups were selected according to the inclusion criteria.

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


Eligibility 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

Primary outcomes:
measure: cognitive adverse events, CoAE
timeFrame: Baseline, 9 weeks, 6 months, 12 months
Secondary outcomes:
measure: Major pathological response rate
timeFrame: Within 30 days after surgery
measure: Montreal Cognitive Assessment, MoCA
timeFrame: 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,
measure: perceived cognitive decline events , PCDE
timeFrame: 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.
measure: complete pathological response rate
timeFrame: Within 30 days after surgery
Other outcomes:
Locations:
city: Guanzhou
country: China
facility: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
state: Guangdong
Study officials:
References: