Early Nutritional Intervention in NPC Patients Undergoing Concurrent Chemoradiotherapy

Guangdong Provincial People's Hospital (Guangdong Provincial Academy of Medical Sciences)

Status: Unknown

Conditions: Malnutrition; Nasopharyngeal Carcinoma

Treatments: Dietary Supplement: oral nutritional supplements

Study type: Interventional

Funder types: Other

Identifiers

NCT04810936

GDREC2018296H(R1)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 272 estimated patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pathologically confirmed nasopharyngeal carcinoma (NPC).
• The clinical stage of NPC is T1-4 N1-3 M0 (AJCC 7th edition).
• Planned to receive concurrent chemoradiotherapy with intensity-modulated radiation therapy (IMRT).
• Age ≥ 18 years and < 75 years.
• Performance status (PS) score 0-1.
• NRS2002<3 .
• Blood regular test should be satisfied the following conditions: white blood cell count ≥3.5×109/L， Neutrophil count ≥1.5×109/L，platelet count ≥100×109/L，hemoglobin ≥10g/L
• Liver and kidney functions test should be satisfied the following conditions: aspartate aminotransferase (AST) and Alanine aminotransferase (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.
• Could complete required oral nutrition, questionnaire survey and follow-up.
• Signed informed consent voluntarily.

Exclusion criteria

• Had a history of head and neck radiotherapy.
• Known allergic reaction to any component of ONS, or severe allergic constitution.
• With any unstable systemic disease (such as uncontrolled infectious diseases, uncontrolled hypertension, uncontrolled metabolic diseases and so on).
• Serious cardiovascular diseases in 6 months (such as Congestive heart failure and myocardial infarction).
• Pregnancy and lactation.
• Other conditions that the investigators consider as inappropriate for enrolling into this study.
• Has a history of malignant tumors in 5 years, except for tumors that have been cured only by surgery and with a disease free survival for five years, cured basal cell carcinoma of skin and cured carcinoma in situ of the cervix.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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272 participants in 2 patient groups

Early ONS intervention group

Experimental group

Description:

Patients in early ONS intervention group will receive nutritional counseling (follow-up visits once a week during radiotherapy and at the 1st and 3rd months after radiotherapy) and ONS intervention in the beginning of radiotherapy. The ONS is prescribed to increase oral intake of patients and to ensure total energy supply is more than 30 kcal/kg/day and protein intake more than 1.2 g/kg/day.

Treatment:

Dietary Supplement: oral nutritional supplements

Standard nutrition intervention group

No Intervention group

Description:

Patients in standard nutrition intervention group will receive nutritional counseling (follow-up visits once a week during radiotherapy and at the 1st and 3rd months after radiotherapy).