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

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Oral Nutritional Supplements From the Beginning of Radiotherapy on Body Weight Loss of Patients With Nasopharyngeal Carcinoma and Its Cost-effectiveness Analysis: A Prospective Multicenter Randomized Controlled Trial

Conditions
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Nasopharyngeal Carcinoma, Nutritional Support

Intervention / Treatment
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* Dietary Supplement: Abbott®Ensure
* Radiation: Intensity Modulated Radiation Therapy
* Drug: cisplatin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>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. | Dietary Supplement: Abbott®Ensure<br>* Abbott®Ensure: 55.8 g each time, three times a day, from the beginning to the end of radiotherapy<br>Radiation: Intensity Modulated Radiation Therapy<br>* The prescribed dose was 68-76 Gy to Planning target volume of the primary tumor (PTVnx), 66-70 Gy to Planning target volume of the cervical lymph node (PTVnd), 60-64 Gy to planning target volume 1 (PTV1), and 50-54 Gy to planning target volume 2 (PTV2) in 30-33 fractions. The details of dose limits for organs at risk were based on the study 0225 from The Radiation Therapy Oncology Group (RTOG 0225).<br>Drug: cisplatin<br>* 80-100 mg/m² cisplatin given intravenously every 3 weeks concurrently with radiotherapy.<br>|
| Other: Control group<br>Conventional dietary instruction and individualized nutritional counselling from the beginning to the end of radiotherapy. | Radiation: Intensity Modulated Radiation Therapy<br>* The prescribed dose was 68-76 Gy to Planning target volume of the primary tumor (PTVnx), 66-70 Gy to Planning target volume of the cervical lymph node (PTVnd), 60-64 Gy to planning target volume 1 (PTV1), and 50-54 Gy to planning target volume 2 (PTV2) in 30-33 fractions. The details of dose limits for organs at risk were based on the study 0225 from The Radiation Therapy Oncology Group (RTOG 0225).<br>Drug: cisplatin<br>* 80-100 mg/m² cisplatin given intravenously every 3 weeks concurrently with radiotherapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of weight loss > 5% | 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 | From time of randomization to the date of radiotherapy ends, up to 7 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nasopharyngeal Carcinoma, Nutritional Support, Chemoradiotherapy, Dietary Supplements, Body Weight, Cost-Effectiveness Analysis