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
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Interventions
- Procedure: Surgical resectionDrug: Carboplatin（ neoadjuvant）Drug: Anti-PD-1 Drugs
- Registration Number
- NCT06575322
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 302
- 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.
-
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Direct surgery group (Group B) Surgical resection The patient was diagnosed with head and neck squamous cell carcinoma (stage I-IVA), untreated, and planned to undergo surgery. Neoadjuvant therapy+ Surgery group( Group A) Carboplatin（ neoadjuvant） 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. Neoadjuvant therapy+ Surgery group( Group A) Anti-PD-1 Drugs 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. Neoadjuvant therapy+ Surgery group( Group A) Paclitaxel （neoadjuvant） 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. Neoadjuvant therapy+ Surgery group( Group A) Surgical resection 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.
- Primary Outcome Measures
Name Time Method Brief Pain Inventory (Short Form) 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 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 Outcome Measures
Name Time Method Complete pathological response rate Within 30 days after surgery Defined as the proportion of subjects without viable tumor cells in the resection specimen to the total subjects
Major pathological response rate Within 30 days after surgery Defined as the proportion of subjects with ≤10% viable tumor cells in resection specimens to total subjects
Trial Locations
- Locations (1)
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
🇨🇳Guanzhou, Guangdong, China