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

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

Interventions

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.

Sponsors & Collaborators

• Fujian Cancer Hospital

  collaborator OTHER_GOV

• The Second Affiliated Hospital of Fujian Medical University

  collaborator OTHER

• The Nanping First Affiliated Hospital of Fujian Medical University

  collaborator UNKNOWN

• Quanzhou First Hospital

  collaborator OTHER

• Fujian Medical University Union Hospital

  collaborator OTHER

• Zhangzhou Affiliated Hospital of Fujian Medical University

  collaborator OTHER

• Hunan Cancer Hospital

  collaborator OTHER

• Jiangxi Provincial Cancer Hospital

  collaborator OTHER

• 900 Hospital of Joint Logistics Support Force of PLA

  collaborator OTHER

• Nanfang Hospital, Southern Medical University

  collaborator OTHER

• The First Affiliated Hospital of Xiamen University

  collaborator OTHER

• Zhongshan Hospital Xiamen University

  collaborator OTHER

• Jinsheng Hong

  lead OTHER

Principal Investigators

• Jinsheng Hong · First Affiliated Hospital of Fujian Medical University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-07-19

Primary Completion

2025-05-15

Completion

2025-05-15

Countries

• China

Study Locations