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
Overview
- Phase
- Not Applicable
- Intervention
- Carboplatin（ neoadjuvant）
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Enrollment
- 302
- Locations
- 1
- Primary Endpoint
- Brief Pain Inventory (Short Form)
- Status
- Recruiting
- Last Updated
- last year
Overview
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 pain, anxiety and depression in patients with operable head and neck squamous cell carcinoma: a prospective cohort study
Investigators
Song Fan, MD
Professor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Eligibility Criteria
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.
Arms & Interventions
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.
Intervention: Carboplatin（ neoadjuvant）
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.
Intervention: Paclitaxel （neoadjuvant）
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.
Intervention: Anti-PD-1 Drugs
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.
Intervention: 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.
Intervention: Surgical resection
Outcomes
Primary Outcomes
Brief Pain Inventory (Short Form)
Time Frame: Baseline, 9 weeks, 6 months, 12 months
The BPI-SF contains 15 items that measure pain severity and pain interference, with each item assessed on an 11-point numeric rating scale ranging from "no pain" (0) to "worst pain imaginable" (10).
HADS
Time Frame: Baseline, 9 weeks, 6 months, 12 months
HADS is a 14-item self-report scale, including two subscales: anxiety (HADS-A) and depression (HADS-D). The total HADS score ranges from 0 to 42, and the subscales range from 0 to 21.
Secondary Outcomes
- Complete pathological response rate(Within 30 days after surgery)
- Major pathological response rate(Within 30 days after surgery)