Malnutrition is very common in locally advanced nasopharyngeal carcinoma(NPC) patients undergoing current chemoradiotherapy (CRT) due to dysphagia, mucositis, nausea and other treatment-related problems. Malnutrition is associated with lower physical functioning, lower immune status, more severe (grade III/IV) late RT-induced toxicities, treatment interruption of chemo(radio)therapy, lower chemotherapy response rates, hospital readmission, impaired quality of life (QoL), and increased mortality. Although the international guidelines recommend early nutritional support in the presence of nutritional risk, the best type of nutritional intervention is still unclear. Individualized dietary counseling showed beneficial effects in nutritional intake, nutritional status and QoL in head and neck cancer patients undergoing RT or CRT-treatment; oral nutritional supplements (ONS) was most acceptable in Chinese NPC patients. Previous nutritional intervention trials in head-neck cancer patients have been conducted on small samples and did not clarify the role of oral nutritional supplements (ONS). Accordingly, although current guidelines recommend as grade A the use of ONS associated with dietary counseling for head-neck cancer patients undergoing RT, the efficacy of this nutritional intervention still needs to be evaluated in adequately sized and randomized clinical trials for Chinese NPC patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
ONS group will receive Healing Elements ONS everyday during CRT
Shanghai ninth people's hospital
Shanghai, Shanghai Municipality, China
Body weight(kg)change during concurrent chemotherapy
Time frame: every week during the course of radiotherapy, up to 6-7 weeks
Disease-free survival
From date of randomization until date of first documented disease progression or death from any cause, assessed up to 2 years.
Time frame: 2 years
Score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Core 35 (EORTC QLQ-HN35) during the concurrent treatment
participants will be followed for the duration of hospital stay, an expected average of 6-7 weeks
Time frame: every 2 weeks during the course of radiotherapy, up to 6-7 weeks
Number of participants with treatment-related adverse events as assessed by CTCAE v3.0
Time frame: every week during the course of radiotherapy, up to 6-7 weeks
Body cell mass(kg) change measured by multifrequency segmental bioelectrical impedance analysis
Time frame: every week during the course of radiotherapy, up to 6-7 weeks
Fat mass (kg) change measured by multifrequency segmental bioelectrical impedance analysis
Time frame: every week during the course of radiotherapy, up to 6-7 weeks
Fat free mass (kg) change measured by multifrequency segmental bioelectrical impedance analysis
Time frame: every week during the course of radiotherapy, up to 6-7 weeks
Skeletal muscle mass (kg) change measured by multifrequency segmental bioelectrical impedance analysis
Time frame: every week during the course of radiotherapy, up to 6-7 weeks
Phase angle(°) change measured by multifrequency segmental bioelectrical impedance analysis
Time frame: every week during the course of radiotherapy, up to 6-7 weeks
Serum albumin（g/L) change
Time frame: every 2 weeks during the course of radiotherapy, up to 6-7 weeks
Serum prealbumin（mg/dL) change
Time frame: every 2 weeks during the course of radiotherapy, up to 6-7 weeks
Serum transferrins（mg/dL）change
Time frame: every 2 weeks during the course of radiotherapy, up to 6-7 weeks
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