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

NCT04823468 | Completed

• 1 other identifier: FYYY-FLK-202001
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 13

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.

Conditions

Nasopharyngeal Carcinoma; Nutritional Support

Keywords

Nasopharyngeal Carcinoma; Nutritional Support; Chemoradiotherapy; Dietary Supplements; Body Weight; Cost-Effectiveness Analysis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• PG-SGA Score

  From time of randomization to the date of radiotherapy ends, up to 7 weeks

• Incidence of participants with grade ≥3 oral mucositis

  During the course of radiotherapy, up to 7 weeks

• Days of radiotherapy interruption

  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)

  From time of randomization to the date of radiotherapy ends, up to 7 weeks

• Increment Cost-Utility Ratio (ICUR）

  During the course of chemoradiotherapy, up to 7 weeks

Study Arms (2)

Experimental group

EXPERIMENTAL

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; Radiation: Intensity Modulated Radiation Therapy; Drug: cisplatin

Control group

OTHER

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

Radiation: Intensity Modulated Radiation Therapy; Drug: cisplatin

Interventions

Abbott®Ensure DIETARY_SUPPLEMENT

Abbott®Ensure: 55.8 g each time, three times a day, from the beginning to the end of radiotherapy

Experimental group

Intensity Modulated Radiation Therapy RADIATION

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).

Control group; Experimental group

cisplatin DRUG

80-100 mg/m² cisplatin given intravenously every 3 weeks concurrently with radiotherapy.

Control group; Experimental group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jinsheng Hong: lead
• Fujian Cancer Hospital: collaborator
• The Second Affiliated Hospital of Fujian Medical University: collaborator
• The Nanping First Affiliated Hospital of Fujian Medical University: collaborator
• Quanzhou First Hospital: collaborator
• Fujian Medical University Union Hospital: collaborator
• Zhangzhou Affiliated Hospital of Fujian Medical University: collaborator
• Hunan Cancer Hospital: collaborator
• Jiangxi Provincial Cancer Hospital: collaborator
• 900 Hospital of Joint Logistics Support Force of PLA: collaborator
• Nanfang Hospital, Southern Medical University: collaborator
• The First Affiliated Hospital of Xiamen University: collaborator
• Zhongshan Hospital Xiamen University: collaborator

Study Sites (13)

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

Location

First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350005, China

Location

Fujian Cancer Hospital

Fuzhou, Fujian, 350014, China

Location

900th hospital of the joint logistics team, PLA

Fuzhou, Fujian, 350025, China

Location

The Nanping First Affiliated Hospital of Fujian Medical University

Nanping, Fujian, 353000, China

Location

Quanzhou First Hospital Affiliated to Fujian Medical University

Quanzhou, Fujian, 362000, China

Location

The Second Affiliated Hospital of Fujian Medical University

Quanzhou, Fujian, 362000, China

Location

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, 361003, China

Location

Zhongshan Hospital Xiamen University

Xiamen, Fujian, 361004, China

Location

Zhangzhou Affiliated Hospital of Fujian Medical University

Zhangzhou, Fujian, 363000, China

Location

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, 510515, China

Location

Hunan Cancer Hospital

Changsha, Hunan, 410013, China

Location

Jiangxi Provincial Cancer Hospital

Nanchang, Jiangxi, 330029, China

Location

MeSH Terms

Conditions

Nasopharyngeal Carcinoma; Body Weight

Interventions

Radiotherapy, Intensity-Modulated; Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Jinsheng Hong

  First Affiliated Hospital of Fujian Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 26, 2021
• First Posted: March 30, 2021
• Study Start: July 19, 2021
• Primary Completion: May 15, 2025
• Study Completion: May 15, 2025
• Last Updated: June 10, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (13)