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NCT Number: NCT04823468

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

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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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

900th hospital of the joint logistics team, PLA, Fuzhou, Fujian, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Abbott®Ensure

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

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

Drug

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Jinsheng Hong

Other

Collaborators

  • 900th Hospital of PLA Joint Logistic Support Force
  • Fujian Cancer Hospital
  • Fujian Medical University Union Hospital
  • Hunan Cancer Hospital
  • Jiangxi Provincial Cancer Hospital
  • Nanfang Hospital, Southern Medical University
  • Quanzhou First Hospital
  • The First Affiliated Hospital of Xiamen University
  • The Nanping First Affiliated Hospital of Fujian Medical University
  • The Second Affiliated Hospital of Fujian Medical University
  • Zhangzhou Affiliated Hospital of Fujian Medical University
  • Zhongshan Hospital Xiamen University

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Mar 30, 2021
Registry last updated
Jun 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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