oral mucositis in patients with nasopharyngeal carcinoma receiving intensity modulated radiotherapy (IMRT) and chemotherapy
Conditions
Interventions
treatment group:wIRA treatment
control group:regular treatment
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Patients between 18-65 years old; 2. ECOG score 0-1; 3. Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, who are planning to receive IMRT combined with chemotherapy; 4. With normal bone marrow, liver and renal function 14 days before enrollment as followed: 1) HGB = 9g/dL; 2) ANC =1.5*10^9/L, PLT = 100*10^9/L , TBIL= 1.5xULN; ALT and AST = 2×ULN; PT/APTT = 1.5×ULN; Creatinine clearance < 1.5xULN; 5. Patients must offer signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with distant metastasis; 2. Patients unable to be observed the oral mucositis due to difficulty in opening mouth; 3. With history of radiotherapy to head and neck; 4. With history of chemotherapy; 5. Patients with acute parotitis, acute otitis media, cataract and epilepsy; 6. Patients with any disease that might influence healing, such as diabetes mellitus or immunity deficient; 7. Patients undertaking photosensitive drugs, including porphyrin, tetracycline, sulfonamide, meladinin, thiophenylamine and so on; 8. Patients with history of heart disease: congestive heart-failure > NYHA grade 2, active coronary heart disease (patients suffered from myocardial infarction 6 months before enrollment could be accepted), arrhythmia that needs anti-arrhythmia therapy (beta receptor blocker and digoxin could be accepted) or uncontrolled hypertension; 9. HIV infection; 10. With severe uncontrolled infections (>grade 2, NCI-CTC v.4.0); 11. With history or tendency to bleeding or medical disorders; 12. In pregnant or lactating Female; 13. With history of photo-therapy in 4 weeks before enrollment; 14. Patients without signing informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| grade of oral mucositis;treatment interruption induced by oral mucositis; | — |
Secondary
| Measure | Time frame |
|---|---|
| The need of analgetic;change of body weight;VAS;the need of parenteral nutrition; | — |
Countries
China
Contacts
Public ContactXiang Guo
Sun Yat-sen University Cancer Center
Outcome results
None listed