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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carboplatin（ neoadjuvant） | Drug | Carboplatin (IV), AUC=5，administered by intravenous (IV) infusion on Day 1 of each 21-day cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Brief Pain Inventory (Short Form) | 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). | Baseline, 9 weeks, 6 months, 12 months |
| HADS | 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. | Baseline, 9 weeks, 6 months, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Major pathological response rate | Defined as the proportion of subjects with ≤10% viable tumor cells in resection specimens to total subjects | Within 30 days after surgery |
| Complete pathological response rate |
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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.
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The patients were diagnosed with head and neck squamous cell carcinoma (stages I-IV) and did not receive treatment. They planned to receive only surgical treatment or combined surgical treatment + chemotherapy and immunotherapy. They were divided into two groups, and the participating groups were selected according to the inclusion criteria.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Song Fan, Doctor | Contact | 13570536658 | +86 | fansong2@mail.sysu.edu.cn |
| Pei-Chia Lu | Contact | 18359253576 | +86 | lupeic@mail2.sysu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Song Fan, Doctor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Recruiting | Guanzhou | Guangdong | 510000 | China |
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| Paclitaxel （neoadjuvant） | Drug | Nab-paclitaxel 260mg/m2 administered by intravenous (IV) infusion on Day 1 of each 21-day cycle |
|
| Anti-PD-1 Drugs | Drug | Anti-PD-1 Drugs 200 mg administered by intravenous (IV) infusion on Day 1 of each 21-day cycle |
|
| Surgical resection | Procedure | Standard of care |
|
Defined as the proportion of subjects without viable tumor cells in the resection specimen to the total subjects
| Within 30 days after surgery |
| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
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