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NCT Number: NCT06575322

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

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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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Guanzhou, Guangdong, 510000, China

Location status: Recruiting

Location contact

Song Fan, Doctor

CONTACT

[email protected]

020-81332477

Song Fan, Doctor

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Carboplatin（ neoadjuvant）

Drug

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

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

Primary outcomes

  1. Brief Pain Inventory (Short Form)

    Time frame: 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).

  2. HADS

    Time frame: 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 outcomes

  1. Major pathological response rate

    Time frame: Within 30 days after surgery

    Defined as the proportion of subjects with ≤10% viable tumor cells in resection specimens to total subjects

  2. Complete pathological response rate

    Time frame: Within 30 days after surgery

    Defined as the proportion of subjects without viable tumor cells in the resection specimen to the total subjects

Study contacts

Contact information is provided by the study sponsor or research team.

Pei-Chia Lu

CONTACT

[email protected]

18359253576 ext. +86

Song Fan, Doctor

CONTACT

[email protected]

13570536658 ext. +86

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Aug 28, 2024
Registry last updated
Aug 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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