The Association of hsCRP and Radiotherapy-Induced Toxicity in Patients With Nasopharyngeal Carcinoma

Study Overview
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Brief Summary
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The primary purpose of this study is to explore the association of high sensitivity C-reactive protein (hsCRP) and radiotherapy(RT)-induced toxicity in patients with nasopharyngeal carcinoma. In each patient, hsCRP levels in the pre- and post-RT plasma samples will be measured according to the schedule we set.

Official Title
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An Explorative Study on the Association of High Sensitivity C-Reactive Protein (hsCRP) and Radiotherapy-Induced Toxicity in Patients With Nasopharyngeal Carcinoma

Conditions
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Nasopharyngeal Carcinoma, Head and Neck Cancer, Toxicity Due to Radiotherapy

Intervention / Treatment
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* Other: clinical measurements


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients were pathologically newly diagnosed with nasopharyngeal carcinoma and had no previous history of other tumors According to the treatment strategies of doctors, patients need to receive radiotherapy with or without chemotherapy (for example, neoadjuvant chemotherapy, concurrent chemotherapy, adjuvant chemotherapy) or targeted therapy Willingness to sign the informed consent and return to enrolling institution for follow-up and data collection Exclusion Criteria: Patients do not conform to the inclusion criteria Pregnant or Nursing women Men or women of childbearing potential who are unwilling to employ adequate contraception Vital organs dysfunction(for example, kidneys, heart, liver, lungs, brain) Other contraindications or unsuitable conditions for radiotherapy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1: Patients with neoadjuvant chemotherapy<br>The patients of group1 will receive one of the following treatments: neoadjuvant chemotherapy & concurrent chemoradiotherapy neoadjuvant chemotherapy & radiotherapy neoadjuvant chemotherapy & radiotherapy & adjuvant chemotherapy | Other: clinical measurements<br>* Only clinical parameters were recorded, no intervention was made.<br>|
| Group 2: Patients without neoadjuvant chemotherapy<br>The patients of group2 will receive one of the following treatments: concurrent chemoradiotherapy concurrent chemoradiotherapy & adjuvant chemoradiotherapy radiotherapy & adjuvant chemotherapy | Other: clinical measurements<br>* Only clinical parameters were recorded, no intervention was made.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hsCRP levels | The hscrp levels in the plasma samples from each participant were measured at the following time points: at the time of diagnosis completion/before the initiation of the first neoadjuvant chemotherapy before the initiation of each neoadjuvant chemotherapy before the initiation of the first radiotherapy during radiotherapy, once a week 1 week and 4weeks after the last radiotherapy | Through treatments completion，12 weeks | 
| Incidence of adverse events | All adverse events were recorded during treatment(for example, oral mucositis, dermatitis). | Through treatments completion，12 weeks |