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Nasopharyngeal CarcinomaNCT04823468

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

A study testing Abbott®Ensure, Intensity Modulated Radiation Therapy and cisplatin in people with Nasopharyngeal Carcinoma and Nutritional Support, run by Jinsheng Hong at 13 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Nasopharyngeal Carcinoma, Nutritional Support
What is being tested?
Abbott®Ensure, Intensity Modulated Radiation Therapy and cisplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
236 participants
Where
13 sitesChina
Study dates
19 Jul 2021to 15 May 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
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  • Pregnant or lactating women;
  • With previous or ongoing clinical trials;
  • Refuse to sign inform consent form.

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

China13 sites

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350001

  • First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian, 350005

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350014

  • 900th hospital of the joint logistics team, PLA

    Fuzhou, Fujian, 350025

  • Nanfang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510515

  • Jiangxi Provincial Cancer Hospital

    Nanchang, Jiangxi, 330029

  • The Nanping First Affiliated Hospital of Fujian Medical University

    Nanping, Fujian, 353000

  • Quanzhou First Hospital Affiliated to Fujian Medical University

    Quanzhou, Fujian, 362000

  • The Second Affiliated Hospital of Fujian Medical University

    Quanzhou, Fujian, 362000

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, 361003

  • Zhongshan Hospital Xiamen University

    Xiamen, Fujian, 361004

  • Zhangzhou Affiliated Hospital of Fujian Medical University

    Zhangzhou, Fujian, 363000

Other trials in China

About this study

Official 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

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.

Being tested
Abbott®Ensure, Intensity Modulated Radiation Therapy, cisplatin
Keywords
Nasopharyngeal Carcinoma, Nutritional Support, Chemoradiotherapy, Dietary Supplements, Body Weight, Cost-Effectiveness Analysis
Medical subject headings
Nasopharyngeal Carcinoma, Body Weight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Abbott®EnsureDietary supplement

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

  • Intensity Modulated Radiation TherapyRadiation

    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).

  • cisplatinDrug

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

Study groups in NCT04823468
Study groupRoleWhat they receive
Experimental groupExperimentalIn 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.
Receives: Dietary Supplement: Abbott®Ensure; Radiation: Intensity Modulated Radiation Therapy; Drug: cisplatin
Control groupOtherConventional dietary instruction and individualized nutritional counselling from the beginning to the end of radiotherapy.
Receives: Radiation: Intensity Modulated Radiation Therapy; Drug: cisplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (6)

  1. PG-SGA Score

    The scores assessed by Patient-Generated Subjective Nutrition Assessment (PG-SGA) at baseline and weekly during the course of radiotherapy

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

  2. Incidence of participants with grade ≥3 oral mucositis

    Incidence of grade 3-4 oral mucositis assessed by CTCAE v5.0, evaluated weekly during radiotherapy

    Measured: During the course of radiotherapy, up to 7 weeks

  3. Days of radiotherapy interruption

    The number of days that radiotherapy was interrupted due to treatment-related toxicity

    Measured: During the course of radiotherapy, up to 7 weeks

  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)

    The standard scores assessed by the EORTC QLQ-C30 v3.0 at baseline and the end of radiotherapy.

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

  5. Increment Cost-Utility Ratio (ICUR）

    The Increment cost-utility ratio is used to assess the economics of ONS, which is calculated as incremental cost divided by incremental utility.

    Measured: During the course of chemoradiotherapy, up to 7 weeks

  6. Score of EQ-5D-5L questionnaire

    The standard scores assessed by the EuroQol- 5 dimension-5 level (EQ-5D-5L ) questionnaire. Collect this questionnaire only in the responsible center.

    Measured: During the course of chemoradiotherapy, up to 7 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2021
  2. Study start19 Jul 2021
  3. Primary completion15 May 2025
  4. Study completion15 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
236 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04823468
Sponsor's protocol ID
FYYY-FLK-202001
Status last verified
May 2025
First submitted
26 Mar 2021
Last updated
10 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Abbott®Ensure, Intensity Modulated Radiation Therapy and cisplatin in people with Nasopharyngeal Carcinoma and Nutritional Support, run by Jinsheng Hong at 13 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of weight loss > 5% (time frame: From time of randomization to the date of radiotherapy ends, up to 7 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04823468.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2025.

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