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

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04303975
• Other study ID #: JM0019002
• Status: Not yet recruiting
• Start date: June 2021
• Est. completion date: December 2021

Study information

• Verified date: June 2020
• Source: Jiangmen Central Hospital
• Contact: Jiarong Chen, PhD
• Phone: 86-0750-3399003
• Email: garwingchan[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Head and Neck Cancer
• Nasopharyngeal Carcinoma
• Toxicity Due to Radiotherapy

Intervention

Other:
• clinical measurements
Only clinical parameters were recorded, no intervention was made.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jiarong Chen, MD

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Incidence of adverse events	All adverse events were recorded during treatment(for example, oral mucositis, dermatitis).	Through treatments completion,12 weeks