The purpose of this study was to investigate the role of immunonutrion compared with standard nutrition in reducing oral mucositis in patients with locally advanced nasopharyngeal carcinoma.
Oral mucositis is the most common adverse reaction in patients with nasopharyngeal carcinoma receiving chemoradiotherapy, of which 40-50% of patients are severe (grade 3-4). Oral mucositis usually results in pain, dysphagia, reduced feeding, and malnutrition. Severe malnutrition in turn increases the risk of severe oral mucositis. Persistent severe oral mucositis will lead to delay and interruption of treatment, impairing patients'quality of life and prognosis. It's reported that nutritional intervention can not only reduce the risk and severity of oral mucositis and improve the nutritional status of patients with head and neck tumors, but also improve patients' tolerance to radiotherapy, quality of life, and prognosis. Immunonutrition refers to the addition of high content of immune nutrients on the basis of sufficient calories, which not only ensures the supply of nutrition, but also takes into account the effects of anti-inflammation, regulating immunity, improving treatment tolerance, improving prognosis and so on. It has been reported that, comparing with standard enteral nutrition, the incidence of severe oral mucositis and esophagitis in patients with head and neck tumors treated with immunonutrition was lower, suffering less weight loss, and the antitumor immune response was enhanced. The 3-year OS and PFS were significantly improved in patients with good compliance. It remains to be seen whether or not NPC patients receiving chemoradiotherapy can be benifit from immunonutritional therapy. Therefore, we conducted a prospective, multi-center, randomized controlled clinical study in patients with nasopharyngeal carcinoma who received radiotherapy and chemotherapy without metastases, to further improve the quality of life and prognosis of patients with nasopharyngeal carcinoma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
190
Enteral immunonutrition (Oral Impact®, Nestle), 250ml/ bottle, 2 bottles per day, from 5 days before radiotherapy to the end of radiotherapy.
Isocaloric standard enteral nutrition formula (ENSURE®), 250 mL per administration, 3 times per day. Preparation of the 250 mL dose involves adding 200 mL of potable water to a cup and slowly stirring in 52.7 g of ENSURE powder (approximately 6 scoops).
Fujian Provincial Hospital
Fuzhou, Fujian, China
The incidence of severe oral mucositis
Incidence of grade 3-4 oral mucositis
Time frame: 7 weeks
The latency period of severe oral mucositis
Total duration from the start of radiotherapy to the severe oral mucositis
Time frame: 7 weeks
The duration period of severe oral mucositis
The number of days of severe oral mucositis during the oral mucositis observation period
Time frame: 7 weeks
Assessment of immune state
T-lymphocyte subsets
Time frame: 4 months
Serum hypersensitive C-reactive protein (hsCRP) level
Change in high sensitivity C-reactive protein from baseline to end of radiotherapy
Time frame: 4 months
Serum Interleukin-6 (IL-6) level
Change in serum level of Interleukin-6 from baseline to end of radiotherapy
Time frame: 4 months
Hemoglobin level
Change in hemoglobin level from baseline to end of radiotherapy
Time frame: 4 months
Serum albumin level
Change in hemoglobin level from baseline to end of radiotherapy
Time frame: 4 months
Serum Pre-Albumin level
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Fujian Cancer Hospital
Fuzhou, Fujian, China
RECRUITINGGuangdong Provincial People's Hospital
Guangzhou, Guangdong, China
RECRUITINGAffiliated Cancer Hospital & Institute of Guangzhou Medical University
Guangzhou, Guangdong, China
RECRUITINGHuizhou Municipal Central Hospital
Huizhou, Guangdong, China
RECRUITINGThe Affiliated Hospital of Guilin Medical University
Guilin, Guangxi, China
RECRUITINGLiuzhou Workers Hospital
Liuchow, Guangxi, China
RECRUITINGThe First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
RECRUITINGWuzhou Red Cross Hospital
Wuzhou, Guangxi, China
RECRUITINGFirst People People's Hospital of Yulin City
Yulin, Guangxi, China
RECRUITING...and 10 more locations
Change in hemoglobin level from baseline to end of radiotherapy
Time frame: 4 months
Nutritional risk
Change in nutritional risk determined by the by the nutrition risk screening-2002 (NRS-2002) from baseline to end of radiotherapy
Time frame: 4 months
Nutrition status
Change in nutritional status determined by the Patient-Generated Subjective Global Assessment (PG-SGA) from baseline to end of radiotherapy
Time frame: 4 months
Physical functional status
Changes in handgrip strength from baseline to end of radiotherapy
Time frame: 4 months
overall survival rate (OS)
compare OS between two groups
Time frame: at 2 years after randomisation
progression-free survival rate (PFS)
compare PFS between two groups
Time frame: at 2 years after randomisation
Locoregional recurrence free survival rate (LRRFS)
compare LRRFS between two groups
Time frame: at 2 years after randomisation
Distance metastasis-free survival rate (DMFS)
compare DMFS between two groups
Time frame: at 2 years after randomisation
Quality of life (QoL) assessed by EORTC QLQ-C30 questionnaire
EORTC QLQ-C30 is a specific quality of life assessment scale based on EORTC QLQ-C 30, with 35 items. All of the scales and single-item measures range from 0 to 100. A EORTC QLQ-C30 is a specific quality of life assessment scale, with 30 items. All of the scales and single-item measures range from 0 to 100. More global and functional scales is better. less symptom scales is better.
Time frame: 4 months
Quality of life (QoL) assessed by the EORTC-QLQ-H&N35 Questionnaire
EORTC QLQ-H\&N35 is a specific quality of life assessment scale based on EORTC QLQ-C 30, with 35 items. All of the scales and single-item measures range from 0 to 100. High scores represent increased (worse) symptoms.
Time frame: 4 months
Number of participants with adverse events
Analysis of acute and late adverse events (AEs) are evaluated.
Time frame: up to 2 years after randomisation