Head and Neck Squamous Cell Carcinoma
Conditions
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
Interventions
Carboplatin (IV), AUC=5，administered by intravenous (IV) infusion on Day 1 of each 21-day cycle
Nab-paclitaxel 260mg/m2 administered by intravenous (IV) infusion on Day 1 of each 21-day cycle
DRUGAnti-PD-1 Drugs
Anti-PD-1 Drugs 200 mg administered by intravenous (IV) infusion on Day 1 of each 21-day cycle
PROCEDURESurgical resection
Standard of care
Sponsors
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Countries
China
Contacts
Primary ContactSong Fan, Doctor
Backup ContactPei-Chia Lu
Outcome results
None listed