Assessing SAA1 Levels to Predict Oral Mucositis from Radiotherapy
A Prospective Cohort Study of Plasma SAA1 Levels in Predicting Response to Radiotherapy-induced Oral Mucositis
This study is testing if measuring a specific protein in the blood can help predict how severe mouth sores will be for patients with head and neck cancer who are getting radiation treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nanfang Hospital, Southern Medical University Academic / other |
| Drugs / interventions | radiation |
| Locations | 5 sites (Guangzhou, Guangdong and 4 other locations) |
| Trial ID | NCT06307314 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the levels of serum amyloid A1 (SAA1) as a biomarker for predicting the response to radiotherapy-induced oral mucositis in patients with nasopharyngeal carcinoma and head and neck tumors. By measuring SAA1 levels before and after radiotherapy, the study seeks to understand the relationship between inflammation and the severity of oral mucositis. The study will be conducted across multiple centers, focusing on patients who are undergoing radiotherapy for their cancer treatment. The findings could help in tailoring treatment plans to minimize side effects and improve patient quality of life.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old with a confirmed diagnosis of nasopharyngeal carcinoma or head and neck tumors who are scheduled to receive radiotherapy.
Not a fit: Patients with contraindications to radiotherapy or those with serious coexisting medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better management strategies for preventing and treating oral mucositis in patients undergoing radiotherapy.
How similar studies have performed: While the use of SAA1 as a biomarker in this context is novel, previous studies have indicated the potential of biomarkers in predicting treatment responses in cancer patients.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Guangzhou, Guangdong and 4 other locations
- Nanfang hospital, Southern medical university — Guangzhou, Guangdong, China (Recruiting)
- Fujian Provinical Hospital — Fuzhou, China (Not_yet_recruiting)
- Huizhou Central People's Hospital — Huizhou, China (Not_yet_recruiting)
- Jieyang People's Hospital — Jieyang, China (Not_yet_recruiting)
- Meizhou People's Hospital, Meizhou Academy of Medical Sciences Meizhou — Meizhou, China (Not_yet_recruiting)
Study contacts
- Principal investigator: Jian Guan, Ph.D. — Nanfang Hospital, Southern Medical University
- Study coordinator: Jian Guan, Ph.D.
- Email: guanjian5461@163.com
- Phone: +8613632102247
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.