Effects of Neoadjuvant Therapy With Carboplatin, Paclitaxel Combined With Anti-PD-1 Drugs on Pain, Anxiety and Depression in Patients With Resectable Head and Neck Squamous Cell Carcinoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

302 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-09-01

Study Completion Date

2027-03-01

Brief Summary

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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 pain, anxiety and depression in patients with operable head and neck squamous cell carcinoma: a prospective cohort study

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Detailed Description

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Conditions

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Head and Neck Squamous Cell Carcinoma

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Carboplatin（ neoadjuvant）

Intervention Type DRUG

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

Paclitaxel （neoadjuvant）

Intervention Type DRUG

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

Anti-PD-1 Drugs

Intervention Type DRUG

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

Surgical resection

Intervention Type PROCEDURE

Standard of care

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.

Surgical resection

Intervention Type PROCEDURE

Standard of care

Interventions

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Carboplatin（ neoadjuvant）

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

Intervention Type DRUG

Paclitaxel （neoadjuvant）

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

Intervention Type DRUG

Anti-PD-1 Drugs

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

Intervention Type DRUG

Surgical resection

Standard of care

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

\- 1: Clinical diagnosis of head and neck squamous cell carcinoma (stage I-IVA), without prior treatment, and planning to undergo either surgical treatment alone or surgical treatment combined with chemotherapy and immunotherapy.

2: Ability to speak Chinese and possess basic reading and writing skills.

Exclusion Criteria

* 1: Presence of mental illnesses such as dementia or delirium.

2: Active use of narcotic drugs, including consuming alcohol more than 4 times per day or more than 4 times per week.

3: Patients who alter their treatment plan during the course of treatment.

4: Current or prior use of antidepressants.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No