Effect of Oral Nutritional Supplements on Body Weight Loss of Patients With Nasopharyngeal Carcinoma

Jinsheng Hong

Status

Completed

Conditions

Nasopharyngeal Carcinoma

Nutritional Support

Treatments

Radiation: Intensity Modulated Radiation Therapy

Dietary Supplement: Abbott®Ensure

Drug: cisplatin

Study type

Interventional

Funder types

Other

Identifiers

NCT04823468

FYYY-FLK-202001

Details and patient eligibility

About

Concurrent chemoradiotherapy(CCRT) is the principal treatment for nasopharyngeal carcinoma(NPC). Studies have shown that malnutrition is very common in patients with NPC after chemoradiotherapy. Malnutrition can lead to weight loss, treatment interruption, prolonged stay in hospital, increased treatment costs, reduced tolerance to anti-tumor therapy, reduced quality of life and shortened survival time. Nutritional intervention can improve the nutritional status, reduce treatment-related toxicity and improve the survival of patients with NPC.

The first choice of nutritional intervention is oral nutritional supplements(ONS). Some retrospective studies with small samples have found that early nutritional intervention can reduce weight loss and severe oral mucositis in patients with NPC, compared with late nutritional intervention. Therefore, the investigators proposed the hypothesis that ONS from the beginning of radiotherapy can reduce the nutritional impairment, treatment-related toxicity and treatment costs of patients with NPC, and improve their quality of life. The aim of this multicenter randomized controlled clinical trial is to evaluate the efficacy and cost utility of ONS from the beginning to the end of radiotherapy.

Enrollment

236 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Newly histologic diagnosis of nasopharyngeal carcinoma;
All genders, range from 18-70 years old;
Clinical stage II-IVa according to the 8th edition of the Union for International Cancer Control/American Joint Committee on Cancer (UICC/AJCC) staging system;
Patient-Generated Subjective Nutrition Assessment (PG-SGA) score ≤8;
Main organ functions test should be satisfied the following conditions: (1) Absolute neutrophil count (ANC) ≥1.5×10^9/L; (2) Platelet (PLT) ≥80×10^9/L; (3) Hemoglobin (Hb) ≥90 g/L; (4) Bilirubin < 1.5 times the upper limit of normal value (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 times the upper limit of normal value; (5) Creatinine < 1.5 times the upper limit of normal value or creatinine clearance rate >60 ml/min.

Exclusion criteria

Patients whose energy intake is less than 60% of the target energy requirement for 3 days or more;
Have or are suffering from other malignant tumors;
Refuse concurrent chemoradiotherapy;
With diabetics, galactosemia, or sever metabolic diseases or endocrine diseases;
Cannot take oral or enteral nutrition, including intestinal obstruction, severe short bowel syndrome or high output fistula, or with severe digestive system diseases;
Known allergic reaction to any component of Abbott®Ensure, or severe allergic constitution;
Pregnant or lactating women;
With previous or ongoing clinical trials;
Refuse to sign inform consent form.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

236 participants in 2 patient groups

Experimental group

Description:

In addition to conventional dietary instruction and individualized nutritional counselling, patients were given additional ONS (Abbott®Ensure of 55.8 g tid) from the beginning to the end of radiotherapy.

Treatment:

Drug: cisplatin

Dietary Supplement: Abbott®Ensure

Radiation: Intensity Modulated Radiation Therapy

Control group

Other group

Description:

Conventional dietary instruction and individualized nutritional counselling from the beginning to the end of radiotherapy.

Treatment:

Drug: cisplatin

Radiation: Intensity Modulated Radiation Therapy