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

Sun Yat-sen University

Status: Enrolling

Conditions: Head and Neck Squamous Cell Carcinoma

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

Study type: Observational

Funder types: Other

Identifiers

NCT06575322

SYSKY-2024-646-01

Details and patient eligibility

About

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

Enrollment: 302 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

302 participants in 2 patient groups

Neoadjuvant therapy+ Surgery group( Group A)

Description:

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.

Treatment:

Drug: Paclitaxel （neoadjuvant）

Drug: Anti-PD-1 Drugs

Procedure: Surgical resection

Drug: Carboplatin（ neoadjuvant）

Direct surgery group (Group B)

Description:

The patient was diagnosed with head and neck squamous cell carcinoma (stage I-IVA), untreated, and planned to undergo surgery.

Treatment:

Procedure: Surgical resection