This single center, open-label, randomized controlled clinical trial was designed to investigate whether early nutritional intervention with oral nutrition supplements in patients with nasopharyngeal carcinoma undergoing chemoradiotherapy will improve nutritional status, quality of life and treatment tolerance.
Concurrent chemoradiotherapy is the standard treatment for locally advanced nasopharyngeal carcinoma (NPC). During chemoradiotherapy, malnutrition is present in 44-88% patients which is associated with adverse clinical outcomes. Although patients receive conventional nutritional intervention recommended by The European Society for Clinical Nutrition and Metabolism guidelines, there are still 35% NPC patients suffering from malnutrition during chemoradiotherapy. Recent studies have shown that early nutritional intervention before radiotherapy reduced the prevalence of malnutrition. However, there are few randomized controlled clinical studies comparing early oral nutritional supplements (ONS) intervention to conventional nutritional intervention in NPC patients undergoing chemoradiotherapy. This single center, open-label, randomized controlled clinical trial was designed to investigate whether early ONS intervention compared to conventional nutritional intervention improves nutritional status, treatment tolerance and quality of life, and decreases the incidence of grade 3-4 treatment related side-effects in NPC patients undergoing chemoradiotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
272
Oral nutritional supplements is usually administrated to improve nutritional status in cancer patients.
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
RECRUITINGThe percentage of patients who lose >5% of initial body weight
Assess body weight at the end of radiotherapy (the weight at the end of radiotherapy - the weight at the beginning of radiotherapy) / the weight at the beginning of radiotherapy \*100 %.
Time frame: 7 weeks
Weight loss at the last day of radiotherapy
The changes of weight at the last day of radiotherapy
Time frame: 7 weeks
Weight loss at the end of 4th week
The changes of weight at the end of 4th week
Time frame: 11 weeks
Patient-generated Subjective Global Assessment (PG-SGA) at the end of the 2nd week, 4th week, the last day of radiotherapy and 1 month after radiotherapy
PG-SGA at the end of the 2nd week, 4th week, the last day of radiotherapy and 1 month after radiotherapy
Time frame: 11 weeks
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 radiation induced grade 3-4 mucositis at the end of 4th week and the last day of radiotherapy
Time frame: 7 weeks
Incidence of any grade 3-4 side-effect (CTCAE 4.03).
Incidence of any grade 3-4 side-effect induced by radiotherapy or chemotherapy during chemoradiotherapy
Time frame: 7 weeks
Incidence of prolonged radiation treatment time caused by side-effects
Incidence of prolonged radiation treatment time caused by chemoradiation related side-effects. Prolonged radiation treatment time is defined as the overall treatment time is longer than plan
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Time frame: 7 weeks
Days prolonged more than planed treatment time caused by side-effects
Days prolonged more than planed treatment time caused by chemoradiation related side-effects
Time frame: 7 weeks
Incidence of unplanned hospitalization in 3 months after radiation
Incidence of unplanned hospitalization in 3 months after radiation. Unplanned hospitalization is defined as hospitalization caused by chemoradiotherapy related side effects
Time frame: 5 months
The changes of QOL-C30 at the end of radiation, the 1st and the 3rd month after radiation as compared with the beginning of radiation
The changes of QOL-C30 at the end of radiation, the 1st and the 3rd month after radiation as compared with the beginning of radiation
Time frame: 5 months
The treatment time of parenteral nutrition (PN) treatment
PN should be started if enteral nutrition (EN) is anticipated (60% of estimated energy expenditure) for more than 10 days. The treatment time of PN should be recorded
Time frame: 5 months
The changes of EORTC Quality of LifeQuestionnaire (QLQ)-H&N35 at the end of radiation, the 1st and the 3rd month after radiation as compared with the beginning of radiation
The changes of EORTC Quality of LifeQuestionnaire (QLQ)-H\&N35 at the end of radiation, the 1st and the 3rd month after radiation as compared with the beginning of radiation
Time frame: 5 months