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

• Conditions: Toxicity Due to Radiotherapy; Nasopharyngeal Carcinoma; Head and Neck Cancer
• Interventions: Other: clinical measurements

• Registration Number: NCT04303975
• Lead Sponsor: Jiarong Chen, MD

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-06
• Study First Submitted QC: 2020-03-07
• Study First Posted: 2020-03-11
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-09
• Last Update Posted: 2020-06-11
• Study Start: 2021-06
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

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

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 2: Patients without neoadjuvant chemotherapy	clinical measurements	The patients of group2 will receive one of the following treatments: 1. concurrent chemoradiotherapy 2. concurrent chemoradiotherapy \& adjuvant chemoradiotherapy 3. radiotherapy \& adjuvant chemotherapy
Group 1: Patients with neoadjuvant chemotherapy	clinical measurements	The patients of group1 will receive one of the following treatments: 1. neoadjuvant chemotherapy \& concurrent chemoradiotherapy 2. neoadjuvant chemotherapy \& radiotherapy 3. neoadjuvant chemotherapy \& radiotherapy \& adjuvant chemotherapy

Primary Outcome Measures

Name	Time	Method
hsCRP levels	Through treatments completion，12 weeks	The hscrp levels in the plasma samples from each participant were measured at the following time points: 1. at the time of diagnosis completion/before the initiation of the first neoadjuvant chemotherapy; 2. before the initiation of each neoadjuvant chemotherapy; 3. before the initiation of the first radiotherapy; 4. during radiotherapy, once a week; 5. 1 week and 4weeks after the last radiotherapy
Incidence of adverse events	Through treatments completion，12 weeks	All adverse events were recorded during treatment(for example, oral mucositis, dermatitis).