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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Carboplatin（ neoadjuvant）, Paclitaxel （neoadjuvant）, Anti-PD-1 Drugs, Surgical resection.
- Who it may be relevant to
- Registry conditions: Head and Neck Squamous Cell Carcinoma. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Drug Carboplatin（ neoadjuvant）
Carboplatin (IV), AUC=5，administered by intravenous (IV) infusion on Day 1 of each 21-day cycle - Drug Paclitaxel （neoadjuvant）
Nab-paclitaxel 260mg/m2 administered by intravenous (IV) infusion on Day 1 of each 21-day cycle - Drug Anti-PD-1 Drugs
Anti-PD-1 Drugs 200 mg administered by intravenous (IV) infusion on Day 1 of each 21-day cycle - Procedure Surgical resection
Standard of care
Primary outcome measures
- Brief Pain Inventory (Short Form) [Time frame: Baseline, 9 weeks, 6 months, 12 months]
- HADS [Time frame: Baseline, 9 weeks, 6 months, 12 months]
Secondary outcome measures (2)
- Major pathological response rate [Time frame: Within 30 days after surgery]
- Complete pathological response rate [Time frame: Within 30 days after surgery]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
China · 1 center
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University — Guanzhou
Identifiers
NCT: NCT06575322 · SYSKY-2024-646-01