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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

236 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-19

Study Completion Date

2025-05-15

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.

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Detailed Description

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Conditions

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Nasopharyngeal Carcinoma Nutritional Support

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Abbott®Ensure

Intervention Type DIETARY_SUPPLEMENT

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

Intensity Modulated Radiation Therapy

Intervention Type 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).

cisplatin

Intervention Type DRUG

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

Control group

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

Group Type OTHER

Intensity Modulated Radiation Therapy

Intervention Type 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).

cisplatin

Intervention Type DRUG

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

Interventions

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Abbott®Ensure

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

Intervention Type DIETARY_SUPPLEMENT

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).

Intervention Type RADIATION

cisplatin

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

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No