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

March 23, 2024 updated by: Jinsheng Hong

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

214

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Recruiting
        • Fujian Medical University Union Hospital
        • Contact:
      • Fuzhou, Fujian, China, 350014
        • Not yet recruiting
        • Fujian Cancer Hospital
        • Contact:
      • Fuzhou, Fujian, China, 350005
        • Recruiting
        • First Affiliated Hospital of Fujian Medical University
        • Contact:
        • Contact:
      • Fuzhou, Fujian, China, 350025
        • Not yet recruiting
        • 900th hospital of the joint logistics team, PLA
        • Contact:
      • Nanping, Fujian, China, 353000
        • Recruiting
        • The Nanping First Affiliated Hospital of Fujian Medical University
        • Contact:
      • Quanzhou, Fujian, China, 362000
        • Recruiting
        • The Second Affiliated Hospital of Fujian Medical University
        • Contact:
      • Quanzhou, Fujian, China, 362000
        • Recruiting
        • Quanzhou First Hospital Affiliated to Fujian Medical University
        • Contact:
      • Xiamen, Fujian, China, 361003
        • Not yet recruiting
        • The First Affiliated Hospital of Xiamen University
        • Contact:
      • Xiamen, Fujian, China, 361004
        • Recruiting
        • Zhongshan Hospital Xiamen University
        • Contact:
      • Zhangzhou, Fujian, China, 363000
        • Not yet recruiting
        • Zhangzhou Affiliated Hospital of Fujian Medical University
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Not yet recruiting
        • Nanfang Hospital of Southern Medical University
        • Contact:
    • Hunan
      • Changsha, Hunan, China, 410013
        • Not yet recruiting
        • Hunan Cancer hospital
        • Contact:
    • Jiangxi
      • Nanchang, Jiangxi, China, 330029
        • Not yet recruiting
        • Jiangxi Provincial Cancer Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
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
Abbott®Ensure: 55.8 g each time, three times a day, from the beginning to the end of radiotherapy
Radiation: Intensity Modulated Radiation Therapy
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).
Drug: cisplatin
80-100 mg/m² cisplatin given intravenously every 3 weeks concurrently with radiotherapy.
Other: Control group
Conventional dietary instruction and individualized nutritional counselling from the beginning to the end of radiotherapy.
Radiation: Intensity Modulated Radiation Therapy
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).
Drug: cisplatin
80-100 mg/m² cisplatin given intravenously every 3 weeks concurrently with radiotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of weight loss > 5%
Time Frame: 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
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
Time Frame: 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
From time of randomization to the date of radiotherapy ends, up to 7 weeks
Incidence of participants with grade ≥3 oral mucositis
Time Frame: 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
During the course of radiotherapy, up to 7 weeks
Days of radiotherapy interruption
Time Frame: During the course of radiotherapy, up to 7 weeks
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)
Time Frame: 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.
From time of randomization to the date of radiotherapy ends, up to 7 weeks
Increment Cost-Utility Ratio (ICUR）
Time Frame: 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.
During the course of chemoradiotherapy, up to 7 weeks
Score of EQ-5D-5L questionnaire
Time Frame: 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.
During the course of chemoradiotherapy, up to 7 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jinsheng Hong

Collaborators

Zhongshan Hospital Xiamen University
Fujian Cancer Hospital
Hunan Cancer Hospital
Jiangxi Provincial Cancer Hospital
Fujian Medical University Union Hospital
The Second Affiliated Hospital of Fujian Medical University
The First Affiliated Hospital of Xiamen University
Zhangzhou Affiliated Hospital of Fujian Medical University
Quanzhou First Hospital Affiliated to Fujian Medical University
The Nanping First Affiliated Hospital of Fujian Medical University
900th hospital of the joint logistics team, PLA
Nanfang Hospital, Southern Medical University

Investigators

  • Principal Investigator: Jinsheng Hong, First Affiliated Hospital of Fujian Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 19, 2021

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

March 26, 2021

First Submitted That Met QC Criteria

March 26, 2021

First Posted (Actual)

March 30, 2021

Study Record Updates

Last Update Posted (Actual)

March 26, 2024

Last Update Submitted That Met QC Criteria

March 23, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FYYY-FLK-202001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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