Predictive Factors of Acute Oral Mucositis Induced by Chemo-radiotherapy for Local Advanced Nasopharyngeal Carcinoma

Nasopharyngeal Neoplasms Clinical Trial

Official title:

Predictive Factors of Acute Oral Mucositis Induced by Intensity-Modulated Radiation Therapy With Concurrent Chemotherapy for Local Advanced Nasopharyngeal Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02945878
• Other study ID #: NPC-MUCO
• Status: Recruiting
• Phase: N/A
• First received: October 25, 2016
• Last updated: June 27, 2017
• Start date: October 2016
• Est. completion date: May 2018

Study information

• Verified date: October 2016
• Source: Zhejiang Cancer Hospital
• Contact: Yuanyuan Chen, Professor
• Phone: +86 13738103808
• Email: chenyy[@]zjcc.org.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a prospective, observational study to analyze the clinical and dosimetric factors about the radiation oral mucositis caused by radical chemo-radiotherapy for nasopharyngeal carcinoma patients and try to find the indicators for acute radiation oral mucositis.

Description:

All patients received 1 - 3 concurrent chemotherapy during the intensity modulated radiotherapy. Before radiotherapy, three types of mouth mucosa are contoured in all treatment plans. Oral mucosa grades are recorded before and during treatment. Dose-volume Histograms are got to analyze the associated factors.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: May 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Histologically conformed Initial nasopharyngeal carcinoma

2. Patients can feed through the mouth.

3. ECOG (Eastern Cooperative Oncology Group) : 0-1.

4. No history of chemo-radiotherapy, immuno-therapy or biotherapy.

5. Normal hemodynamic indices before the recruitment (including white blood cell count>4.0×109/L, neutrophil count>1.5×109/L, platelet count >100×109/L, hemoglobin=90g/l, normal liver/kidney function).

6. Informed consent signed.

Exclusion Criteria:

1. History of malignant tumors.

2. Any severe complications contraindicated chemotherapy or radiotherapy.

3. Medical history of central nervous system, cognitive or psychological diseases;

4. Pregnant or nursing women.

5. Patients with mental disease cannot complete the questionaire.

6. Patients refused the informed consent.

Related Conditions & MeSH terms

• Mucositis
• Nasopharyngeal Neoplasms
• Stomatitis

Locations

Country	Name	City	State
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	gradings of oral mucositis		3 months