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NCT Number: 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

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Guanzhou, Guangdong, 510000, China

Location status: Recruiting

Location contact

Song Fan, Doctor

CONTACT

[email protected]

020-81332477

Song Fan, Doctor

PRINCIPAL_INVESTIGATOR

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Carboplatin( neoadjuvant)

Drug

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

Paclitaxel (neoadjuvant)

Drug

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

Anti-PD-1 Drugs

Drug

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

Surgical resection

Procedure

Standard of care

Primary outcomes

  1. cognitive adverse events, CoAE

    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).

Secondary outcomes

  1. Major pathological response rate

    Time frame: Within 30 days after surgery

    Defined as the proportion of subjects with ≤10% viable tumor cells in resection specimens to total subjects

  2. Montreal Cognitive Assessment, MoCA

    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

  3. perceived cognitive decline events , PCDE

    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

  4. complete pathological response rate

    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

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2026
First posted
Aug 28, 2024
Registry last updated
Aug 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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