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

Not Applicable

Active, not recruiting

• Conditions: Nutritional Support; Nasopharyngeal Carcinoma
• Interventions: Radiation: Intensity Modulated Radiation Therapy; Dietary Supplement: Abbott®Ensure; Drug: cisplatin

• Registration Number: NCT04823468
• Lead Sponsor: Jinsheng Hong

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-26
• Study First Submitted QC: 2021-03-26
• Study First Posted: 2021-03-30
• Study Start: 2021-07-19
• Primary Completion: 2025-03-26
• Status Verified: 2025-05
• Study Completion: 2025-05
• Last Update Submitted: 2025-05-07
• Last Update Posted: 2025-05-13

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 214

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Intensity Modulated Radiation Therapy	Conventional dietary instruction and individualized nutritional counselling from the beginning to the end of radiotherapy.
Experimental group	Abbott®Ensure	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.
Experimental group	Intensity Modulated Radiation Therapy	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.
Experimental group	cisplatin	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.
Control group	cisplatin	Conventional dietary instruction and individualized nutritional counselling from the beginning to the end of radiotherapy.

Primary Outcome Measures

Name	Time	Method
Incidence of weight loss > 5%	From time of randomization to the date of radiotherapy ends, up to 7 weeks	The percentage of patients whose body weight decreased more than 5% over baseline, body weight (in kilograms) are measured at baseline and weekly during the course of radiotherapy

Secondary Outcome Measures

Name	Time	Method
Days of radiotherapy interruption	During the course of radiotherapy, up to 7 weeks	The number of days that radiotherapy was interrupted due to treatment-related toxicity
Increment Cost-Utility Ratio (ICUR）	During the course of chemoradiotherapy, up to 7 weeks	The Increment cost-utility ratio is used to assess the economics of ONS, which is calculated as incremental cost divided by incremental utility.
PG-SGA Score	From time of randomization to the date of radiotherapy ends, up to 7 weeks	The scores assessed by Patient-Generated Subjective Nutrition Assessment (PG-SGA) at baseline and weekly during the course of radiotherapy
Incidence of participants with grade ≥3 oral mucositis	During the course of radiotherapy, up to 7 weeks	Incidence of grade 3-4 oral mucositis assessed by CTCAE v5.0, evaluated weekly during radiotherapy
Score of EQ-5D-5L questionnaire	During the course of chemoradiotherapy, up to 7 weeks	The standard scores assessed by the EuroQol- 5 dimension-5 level (EQ-5D-5L ) questionnaire. Collect this questionnaire only in the responsible center.
Score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 v3.0 (EORTC QLQ-C30 v3.0)	From time of randomization to the date of radiotherapy ends, up to 7 weeks	The standard scores assessed by the EORTC QLQ-C30 v3.0 at baseline and the end of radiotherapy.

Trial Locations

Locations (13)

Fujian Medical University Union Hospital; 🇨🇳 Fuzhou, Fujian, China

First Affiliated Hospital of Fujian Medical University; 🇨🇳 Fuzhou, Fujian, China

Fujian Cancer Hospital; 🇨🇳 Fuzhou, Fujian, China

900th hospital of the joint logistics team, PLA; 🇨🇳 Fuzhou, Fujian, China

The Nanping First Affiliated Hospital of Fujian Medical University; 🇨🇳 Nanping, Fujian, China

Quanzhou First Hospital Affiliated to Fujian Medical University; 🇨🇳 Quanzhou, Fujian, China

The Second Affiliated Hospital of Fujian Medical University; 🇨🇳 Quanzhou, Fujian, China

The First Affiliated Hospital of Xiamen University; 🇨🇳 Xiamen, Fujian, China

Zhongshan Hospital Xiamen University; 🇨🇳 Xiamen, Fujian, China

Zhangzhou Affiliated Hospital of Fujian Medical University; 🇨🇳 Zhangzhou, Fujian, China

Nanfang Hospital of Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China

Hunan Cancer Hospital; 🇨🇳 Changsha, Hunan, China

Jiangxi Provincial Cancer Hospital; 🇨🇳 Nanchang, Jiangxi, China