Randomized controlled trial for early ONS treatment vs standard nutrition treatment in patients with nasopharyngeal carcinoma undergoing concurrent chemoradiotherapy

Authors
Category Primary study
Registry of TrialsChinese Clinical Trial Register
Year 2019
INTERVENTION: experimental group:early ONS;control group:normal nutrition treatment; CONDITION: nasopharyngeal carcinoma PRIMARY OUTCOME: percentage of weight loss at the end of radiotherapy; SECONDARY OUTCOME: 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; 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.
Epistemonikos ID: 4db48008f8c0124cfc082af8c8a19e0b60b893b5
First added on: Aug 24, 2024