Malignant Neoplasm of Nasopharynx
Conditions
Keywords
nasopharyngeal carcinoma, intensity-modulated radiotherapy, nutrition support, nutrition assessment
Brief summary
The chemo-radiotherapy for the local advanced nasopharyngeal carcinoma patients will induce the mucosal ulcer and damage salivary glands. Consequently, it can disturb the nutrition conditions and clinical outcomes of patients. This research tries to evaluate the nutrition status at the baseline, before and after radiotherapy, during the follow-up by the body mass index, hematological indexes, immunological indexes, and nutrition questionnaires including PG-SGA and NRS 2002. Through the evaluation of two different nutritional interventions, the investigators aim to find an optimized assessment model and the best nutrition support patterns.
Detailed description
All nasopharyngeal patients received radical treatment including neo-adjuvant chemotherapy and concurrent chemo-radiotherapy. At the beginning, the investigators assign patient to experimental and control groups randomly. Patients in experimental group received standard nutritional support by adding NUTRISON. Control patients will give conventional nutritional guidance. The investigators collected all the nutritional indexed at first visit, before and after radiotherapy, 1, 3, 6, 9, 12 months after radiotherapy. All these data will be set into statistical software to produce an optimized model for clinical practice.
Interventions
DIETARY_SUPPLEMENTNutrison
Nutrison(400-600ml/d) will be given to Arm 1 patient between regular diet. When the daily ration was cut down to 50%,100ml/h Nutrison was added. When grade Ⅲ-Ⅳ oral mucositis appeared, total Nutrison was applied to patients by NG or PEG.
Sponsors
Zhejiang Cancer Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Histologically conformed Initial nasopharyngeal carcinoma 2. Patients can feed through the mouth. 3. ECOG (Eastern Cooperative Oncology Group) : 0-2. 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 | Description |
|---|---|---|
| Overall survival | 5 years | From the first treatment to the death of any causes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progress free survival | 5 years | From the first treatment to the progress of diseases |
Countries
China
Outcome results
None listed