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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02945878

Enrollment

Registered

2016-10-26

Start date

2016-10-31

Completion date

2018-05-31

Last updated

2017-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nasopharyngeal Neoplasms, Stomatitis

Keywords

radiotherapy, oral mucositis,oral mucosa protection

Brief 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.

Detailed 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
gradings of oral mucositis	3 months

Countries

China

Contacts

Primary ContactYuanyuan Chen, Professor

chenyy@zjcc.org.cn+86 13738103808

Backup ContactShuang Huang, Doctor

hnhuangshuang525@163.com+86 18069801225

Outcome results