Plasma SAA1 Levels in Predicting Response to Radiotherapy-induced Oral Mucositis

Recruiting

• Conditions: Biomarker; Head and Neck Cancer; Nasopharyngeal Carcinoma; Radiotherapy-induced Oral Mucositis

• Registration Number: NCT06307314
• Lead Sponsor: Nanfang Hospital, Southern Medical University

Brief Summary

Head and neck squamous cell carcinoma (SCC) is the sixth most common cancer worldwide, with more than 700,000 new cases and more than 350,000 deaths each year. At present, radiotherapy is an important measure to control the recurrence of head and neck tumors, but almost all patients with head and neck squamous cell carcinoma will have acute inflammatory reactions such as radiotherapy-induced oral mucositis (RIOM) after radiotherapy, which seriously affects the quality of life and radiotherapy efficacy of patients. Serum amyloid A1 (SAA1) is an acute phase protein associated with inflammation. Our previous basic research found that serum SAA1 expression levels can be used as biomarkers to assess the dose received by the receptor in the early stages of radiation damage. At the same time, we confirmed that the serum level of SAA1 in patients with nasopharyngeal carcinoma increased after radiotherapy. Therefore, we intend to conduct a prospective, multicenter, observational study to further explore the predictive power of plasma SAA1 levels for radiotherapy-induced oral mucositis, with a view to early screening and prevention of RIOM patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-01
• Status Verified: 2024-03
• Study First Submitted: 2024-03-06
• Study First Submitted QC: 2024-03-06
• Last Update Submitted: 2024-03-06
• Study First Posted: 2024-03-12
• Last Update Posted: 2024-03-12
• Primary Completion: 2026-12-01
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Over 18 years of age.
• Voluntarily sign informed consent.
• The pathological diagnosis was nasopharyngeal carcinoma, head and neck tumor.
• Need to be treated with radiotherapy.
• ECOG PS Score: 0/1.

Exclusion Criteria

• There are contraindications to radiotherapy.
• Combined with other tumors.
• Patients had any serious coexisting medical conditions that could pose an unacceptable risk or negatively affect trial adherence. For example, unstable heart disease requiring treatment, chronic hepatitis, kidney disease, poor disease status, uncontrolled diabetes (fasting blood glucose > 1.5 × ULN), and mental illness.
• At the investigator's discretion, those who was not considered to be suitable for participation in the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Different grades radiotherapy-induced oral mucositis	Through study completion, up to 3 years	The incidence different grades of radiotherapy-induced oral mucositis will be calculated.

Secondary Outcome Measures

Name	Time	Method
Start and duration of radiotherapy-induced oral mucositis	Through study completion, up to 3 years	Calculated the onset time and duration of radiotherapy-induced oral mucositis.
Side effects of radiotherapy	Through study completion, up to 3 years	Record other early or late side effects caused by radiotherapy.
Tumor response	Through study completion, up to 3 years	The efficacy of tumor therapy was evaluated based on RECIST 1.1.

Trial Locations

Locations (5)

Fujian Provinical Hospital; 🇨🇳 Fuzhou, China

Huizhou Central People's Hospital; 🇨🇳 Huizhou, China

Nanfang hospital, Southern medical university; 🇨🇳 Guangzhou, Guangdong, China

Jieyang People's Hospital; 🇨🇳 Jieyang, China

Meizhou People's Hospital, Meizhou Academy of Medical Sciences Meizhou; 🇨🇳 Meizhou, China