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

NCT06575322 | Recruiting

• 1 other identifier: SYSKY-2024-646-01
• Study Type: observational
• Target: 302
• Locations: 1 country
• Sites: 1

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

Conditions

Head and Neck Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (2)

• Major pathological response rate

  Within 30 days after surgery

• Complete pathological response rate

  Within 30 days after surgery

Study Arms (2)

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.

Drug: Carboplatin（ neoadjuvant）; Drug: Paclitaxel （neoadjuvant）; Drug: Anti-PD-1 Drugs; Procedure: Surgical resection

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.

Procedure: Surgical resection

Interventions

Carboplatin（ neoadjuvant） DRUG

Carboplatin (IV), AUC=5，administered by intravenous (IV) infusion on Day 1 of each 21-day cycle

Neoadjuvant therapy+ Surgery group( Group A)

Paclitaxel （neoadjuvant） DRUG

Nab-paclitaxel 260mg/m2 administered by intravenous (IV) infusion on Day 1 of each 21-day cycle

Neoadjuvant therapy+ Surgery group( Group A)

Anti-PD-1 Drugs DRUG

Anti-PD-1 Drugs 200 mg administered by intravenous (IV) infusion on Day 1 of each 21-day cycle

Neoadjuvant therapy+ Surgery group( Group A)

Surgical resection PROCEDURE

Standard of care

Direct surgery group (Group B); Neoadjuvant therapy+ Surgery group( Group A)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• \- 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.
• : Ability to speak Chinese and possess basic reading and writing skills.

You may not qualify if:

• : Presence of mental illnesses such as dementia or delirium.
• : Active use of narcotic drugs, including consuming alcohol more than 4 times per day or more than 4 times per week.
• : Patients who alter their treatment plan during the course of treatment.
• : Current or prior use of antidepressants.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Guanzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Study Officials

• Song Fan, Doctor

  Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  STUDY CHAIR

Central Study Contacts

Song Fan, Doctor

CONTACT

13570536658; fansong2@mail.sysu.edu.cn

Pei-Chia Lu

CONTACT

18359253576; lupeic@mail2.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 23, 2024
• First Posted: August 28, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: August 28, 2024

Record last verified: 2024-08

Locations

CN (1)