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

Head and Neck Cancer Clinical Trial

Official title:

A Prospective Cohort Study of Plasma SAA1 Levels in Predicting Response to Radiotherapy-induced Oral Mucositis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06307314
• Other study ID #: NFEC-2024-093
• Status: Recruiting
• Start date: February 1, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: March 2024
• Source: Nanfang Hospital, Southern Medical University
• Contact: Jian Guan, Ph.D.
• Phone: +8613632102247
• Email: guanjian5461[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2026
• Est. primary completion date: December 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Biomarker
• Head and Neck Cancer
• Head and Neck Neoplasms
• Mucositis
• Nasopharyngeal Carcinoma
• Stomatitis

Locations

Country	Name	City	State
China	Fujian Provinical Hospital	Fuzhou
China	Nanfang hospital, Southern medical university	Guangzhou	Guangdong
China	Huizhou Central People's Hospital	Huizhou
China	Jieyang People's Hospital	Jieyang
China	Meizhou People's Hospital, Meizhou Academy of Medical Sciences Meizhou	Meizhou

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital, Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Different grades radiotherapy-induced oral mucositis	The incidence different grades of radiotherapy-induced oral mucositis will be calculated.	Through study completion, up to 3 years
Secondary	Start and duration of radiotherapy-induced oral mucositis	Calculated the onset time and duration of radiotherapy-induced oral mucositis.	Through study completion, up to 3 years
Secondary	Side effects of radiotherapy	Record other early or late side effects caused by radiotherapy.	Through study completion, up to 3 years
Secondary	Tumor response	The efficacy of tumor therapy was evaluated based on RECIST 1.1.	Through study completion, up to 3 years