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

NCT06576180 | Recruiting

• 1 other identifier: SYSKY-2024-647-01
• Study Type: observational
• Target: 306
• Locations: 1 country
• Sites: 1

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

Conditions

Head and Neck Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Major pathological response rate

  Within 30 days after surgery

• 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,

• 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.

• complete pathological response rate

  Within 30 days after surgery

Study Arms (3)

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.

Drug: Carboplatin（ neoadjuvant）; Drug: Paclitaxel （neoadjuvant）; Drug: Anti-PD-1 Drugs; Procedure: Surgical resection

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

Healthy people (Group C)

Healthy people

Interventions

Carboplatin（ neoadjuvant） DRUG

Carboplatin (IV), AUC=5，administered by intravenous (IV) infusion on Day 1 of each 21-day cycle

Neoadjuvant therapy+ Surgery group( Group A)

Paclitaxel （neoadjuvant） DRUG

Paclitaxel 260mg/m2 administered by intravenous (IV) infusion on Day 1 of each 21-day cycle

Neoadjuvant therapy+ Surgery group( Group A)

Anti-PD-1 Drugs DRUG

Anti-PD-1 Drugs 200 mg administered by intravenous (IV) infusion on Day 1 of each 21-day cycle

Neoadjuvant therapy+ Surgery group( Group A)

Surgical resection PROCEDURE

Standard of care

Direct surgery group (Group B); Neoadjuvant therapy+ Surgery group( Group A)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• : 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.
• : Can speak Chinese and have certain reading and writing skills
• : Healthy group: Dental inpatients with non-oral cancer, no history of neurological diseases, and no previous history of malignant tumors

You may not qualify if:

• : Brain tumor, brain injury, or stroke at baseline or during follow-up
• : A history of stroke or a medical condition that puts you at high risk for future dementia or recurrence
• : Active mental illness or active narcotic drug use, including using alcohol more than 4 times per day or more than 4 times per week
• : Neurocognitive diseases that affect cognitive function, such as Parkinson's disease or Alzheimer's disease
• : History of drug-associated encephalopathy or brain infection
• : Patients who change their treatment plan during treatment
• : Patients who are currently taking or have taken antidepressants

Sponsors & Collaborators

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

Study Sites (1)

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Guanzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 23, 2024
• First Posted: August 28, 2024
• Study Start: August 23, 2024
• Primary Completion: September 1, 2024
• Study Completion (Estimated): September 1, 2026
• Last Updated: August 28, 2024

Record last verified: 2024-08

Locations

CN (1)