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NCT Number: NCT06307314

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nanfang hospital, Southern medical university, Guangzhou, Guangdong, China

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Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Primary outcomes

  1. Different grades radiotherapy-induced oral mucositis

    Time frame: Through study completion, up to 3 years

    The incidence different grades of radiotherapy-induced oral mucositis will be calculated.

Secondary outcomes

  1. Start and duration of radiotherapy-induced oral mucositis

    Time frame: Through study completion, up to 3 years

    Calculated the onset time and duration of radiotherapy-induced oral mucositis.

  2. Side effects of radiotherapy

    Time frame: Through study completion, up to 3 years

    Record other early or late side effects caused by radiotherapy.

  3. Tumor response

    Time frame: Through study completion, up to 3 years

    The efficacy of tumor therapy was evaluated based on RECIST 1.1.

Study contacts

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

Jian Guan, Ph.D.

CONTACT

[email protected]

+8613632102247

Sponsors and collaborators

Lead sponsor

Nanfang Hospital, Southern Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 12, 2024
Registry last updated
Mar 12, 2024

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

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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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