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

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

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

Study Overview

• Status: Recruiting
• Conditions: Head and Neck Squamous Cell Carcinoma
• Intervention / Treatment: Procedure: Surgical resection; Drug: Carboplatin（ neoadjuvant）; Drug: Paclitaxel （neoadjuvant）; Drug: Anti-PD-1 Drugs

• Study Type: Observational
• Enrollment (Estimated): 306

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guanzhou, Guangdong, China, 510000
      • Recruiting
      • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
      • Principal Investigator: Song Fan, Doctor
      • Contact: Song Fan, Doctor; Phone Number: 020-81332477; Email: fansong2@mail.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Neoadjuvant therapy+ Surgery group( Group A); The patient was diagnosed with head and neck squamous cell carcinoma (stage I-IVA), untreated, and planned to undergo surgical treatment + combined chemotherapy and immunotherapy.	Procedure: Surgical resection; Standard of care; Drug: Carboplatin（ neoadjuvant）; Carboplatin (IV), AUC=5，administered by intravenous (IV) infusion on Day 1 of each 21-day cycle; Drug: Paclitaxel （neoadjuvant）; Paclitaxel 260mg/m2 administered by intravenous (IV) infusion on Day 1 of each 21-day cycle; Drug: Anti-PD-1 Drugs; Anti-PD-1 Drugs 200 mg administered by intravenous (IV) infusion on Day 1 of each 21-day cycle
Direct surgery group (Group B); The patient was diagnosed with head and neck squamous cell carcinoma (stage I-IVA), untreated, and planned to undergo surgery.	Procedure: Surgical resection; Standard of care
Healthy people (Group C); Healthy people

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cognitive adverse events, CoAE	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).	Baseline, 9 weeks, 6 months, 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major pathological response rate	Defined as the proportion of subjects with ≤10% viable tumor cells in resection specimens to total subjects	Within 30 days after surgery
Montreal Cognitive Assessment, MoCA	Baseline, 9 weeks, 6 months, 12 months	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,
perceived cognitive decline events , PCDE	Baseline, 9 weeks, 6 months, 12 months	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.
complete pathological response rate	Defined as the proportion of subjects without viable tumor cells in the resection specimen to the total subjects	Within 30 days after surgery

Collaborators and Investigators

• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study record dates

Study Major Dates

• Study Start (Estimated): August 23, 2024
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: August 23, 2024
• First Submitted That Met QC Criteria: August 27, 2024
• First Posted (Actual): August 28, 2024

Study Record Updates

• Last Update Posted (Actual): August 28, 2024
• Last Update Submitted That Met QC Criteria: August 27, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Head and Neck Neoplasms; Neoplasms, Squamous Cell; Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Carboplatin; Paclitaxel
• Other Study ID Numbers: SYSKY-2024-647-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No