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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 302
- 试验地点
- 1
- 主要终点
- Brief Pain Inventory (Short Form)
研究概览
简要总结
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
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Carboplatin（ neoadjuvant） (Drug)
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.
干预措施: Paclitaxel （neoadjuvant） (Drug)
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.
干预措施: Anti-PD-1 Drugs (Drug)
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.
干预措施: Surgical resection (Procedure)
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.
干预措施: Surgical resection (Procedure)
结局指标
主要结局
Brief Pain Inventory (Short Form)
时间窗: 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
时间窗: 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.
次要结局
- Complete pathological response rate(Within 30 days after surgery)
- Major pathological response rate(Within 30 days after surgery)
研究者
Song Fan, MD
Professor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University