nasopharyngeal carcinoma
Conditions
Interventions
experimental group:early ONS
control group:normal nutrition treatment
Sponsors
Guangdong General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Pathologically confirmed nasopharyngeal carcinoma (NPC); 2. The clinical stage of NPC is TxN1-3M0 (AJCC 7th edition); 3. Planned to receive concurrent chemoradiotherapy with intensity-modulated radiation therapy (IMRT). 4. Aged 18 to 75 years; 5. Performance status (PS) score 0-1; 6. NRS2002<3; 7. Blood regular test should be satisfied the following conditions: white blood cell count =3.5×10^9/L Neutrophil count =1.5×10^9/Lplatelet count =100×10^9/Lhemoglobin =10g/L; 8. Liver and kidney functions test should be satisfied the following conditions: AST and ALT < 2.5 times the upper limit of normal value, bilirubin < 1.2 times the upper limit of normal value, creatinine < 1.2 times the upper limit of normal value, and alkaline phosphatase < 5 times the upper limit of normal value; 9. Could complete required oral nutrition, questionnaire survey and follow-up; 10. Signed informed consent voluntarily.
Exclusion criteria
Exclusion criteria: 1. Had a history of head and neck radiotherapy; 2. Known allergic reaction to any component of ONS, or severe allergic constitution; 3. With any unstable systemic disease (such as uncontrolled infectious diseases, uncontrolled hypertension, uncontrolled metabolic diseases and so on); 4. Serious cardiovascular diseases in 6 months (such as Congestive heart failure and myocardial infarction); 5. Pregnancy and lactation; 6. Other conditions that the investigators consider as inappropriate for enrolling into this study; 7. Has a history of malignant tumors in 5 years, except for tumors that have been cured only by surgery and with a disease free survival for five years, cured basal cell carcinoma of skin and cured carcinoma in situ of the cervix.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| percentage of weight loss at the end of radiotherapy; | — |
Secondary
| Measure | Time frame |
|---|---|
| The changes of weight at the end of 4th week and the last day of radiotherapy;PGS-GA at the end of the 2nd week, 4th week, the last day of radiotherapy and 1 month after radiotherapy;Incidence of radiation induced grade 3-4 mucositis (CTCAE 4.03) at the end of 4th week and the last day of radiotherapy;Incidence of any grade 3-4 side-effect (CTCAE 4.03);Incidence of prolonged radiation treatment time caused by side-effects;Days prolonged more than planed treatment time caused by side-effects;Incidence of unplanned hospitalization in 3 months after radiation.;The changes of QOL-C30, EORTC QLQ-H&N35 at the end of radiation, the 1st and the 3rd month after radiation as compared with the beginning of radiation; | — |
Countries
China
Contacts
Public ContactPAN YI
Guangdong General Hospital
Outcome results
None listed