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

NCT04303975 | Unknown

• 1 other identifier: JM0019002
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• hsCRP levels

  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

  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

Study Arms (2)

Group 1: Patients with neoadjuvant chemotherapy

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

Other: clinical measurements

Group 2: Patients without neoadjuvant chemotherapy

The patients of group2 will receive one of the following treatments: 1. concurrent chemoradiotherapy 2. concurrent chemoradiotherapy \& adjuvant chemoradiotherapy 3. radiotherapy \& adjuvant chemotherapy

Other: clinical measurements

Interventions

clinical measurements OTHER

Only clinical parameters were recorded, no intervention was made.

Group 1: Patients with neoadjuvant chemotherapy; Group 2: Patients without neoadjuvant chemotherapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with nasopharyngeal carcinoma during the conducting of this trail at Jiangmen Central Hospital.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jiarong Chen, MD: lead

MeSH Terms

Conditions

Nasopharyngeal Carcinoma; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Study Officials

• Jiarong Chen, PhD

  Affiliated Jiangmen Hospital of Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiarong Chen, PhD

CONTACT

86-0750-3399003; garwingchan@163.com

Yanghao Ruan

CONTACT

ruanyanghao@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 6, 2020
• First Posted: March 11, 2020
• Study Start: June 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: June 11, 2020

Record last verified: 2020-06