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Nasopharyngeal CarcinomaPhase 3NCT04436965

Effect of Standard Nutrition Therapy on Nutritional Status and Prognosis in Locoregionally Advanced Nasopharyngeal Carcinoma Patients With Malnutrition

A Phase 3 study testing Standardized nutrition therapy, Cisplatin and Intensity Modulated Radiation Therapy in people with Nasopharyngeal Carcinoma and Nutrition Therapy, run by Sun Yat-sen University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is a multicenter, randomized controlled, phase III clinical trial. The purpose of this study is to evaluate the efficacy of standard nutrition treatment versus conventional nutrition treatment in local advanced nasopharyngeal carcinoma patients. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Nasopharyngeal Carcinoma, Nutrition Therapy
What is being tested?
Standardized nutrition therapy, Cisplatin and Intensity Modulated Radiation Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
266 participants
Where
1 siteChina
Study dates
16 Aug 2021to Dec 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Newly histologic diagnosis of nasopharyngeal carcinoma(WHO II/III);
  • All genders，range from 18～65 years old;
  • Karnofsky performance status(KPS) ≥ 80;
  • Clinical stage III~IVa(AJCC/UICC 8th);
  • Without significant digestive system disease，nutritional and metabolic diseases or endocrine disease
  • Without significant cardiac，respiratory，kidney or liver disease;
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  • Not received radiotherapy, chemotherapy and other anti-tumor treatment(including immunotherapy);
  • White blood cell(WBC) count ≥ 4×109/L, neutrophile granulocyte(NE) count ≥ 1.5×109/L, Hemoglobin(HGB) ≥ 9g/L, platelet(PLT) count ≥ 100×109/L
  • Total bilirubin(TBIL)、alanine aminotransferase (ALT) or aspartate aminotransferase(AST) < 2.5×upper limit of normal(ULN);
  • Adequate renal function: BUN/CRE ≤ 1.5×ULN or endogenous creatinine clearance ≥ 60ml/min (Cockcroft-Gault formula);
  • No contraindications to chemotherapy or radiotherapy;
  • Inform consent form;

Who cannot join

  • Have some PEG/PEJ contraindications, such as coagulopathy, recent anticoagulant medications and aspirin, gastric ulcer or history of gastric bleeding, portal hypertension combined with abdominal and esophageal fundal varices, pyloric obstruction due to residual stomach under the costal arch after various major gastrectomy or various reasons;
  • Distance metastases;
  • Have or are suffering from other malignant tumors;
  • Participating in other clinical trials;
  • Drug or alcohol addition;
  • Do not have full capacity for civil acts;
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  • Mental disorder;
  • Pregnancy or lactation;
  • Severe complication, eg, uncontrolled hypertension;

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jingjing Miao, MD contact

86-13631355201

miaojingjing90@163.com

China1 site, 1 recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

    Chong Zhao, MD, 02087342638, zhaochong@sysucc.org.cn

    Recruiting

Other trials in China

About this study

Official title: Effect of Standard Nutrition Therapy on Nutritional Status and Prognosis in Locoregionally Advanced Nasopharyngeal Carcinoma Patients With Malnutrition: A Prospective, Multicenter, Phase III Randomized Control Clinical Trial

This is a multicenter, randomized controlled, phase III clinical trial. The purpose of this study is to evaluate the efficacy of standard nutrition treatment versus conventional nutrition treatment in local advanced nasopharyngeal carcinoma patients.

Being tested
Standardized nutrition therapy, Cisplatin, Intensity Modulated Radiation Therapy
Medical subject headings
Nasopharyngeal Carcinoma

What participants receive

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

  • Standardized nutrition therapyOther

    Standardized nutrition therapy with ONS, nasal feeding tube, PEG or parenteral nutrition

  • CisplatinDrug

    Also called DDP

    Patients in both arms received concurrent cisplatin chemotherapy:100 mg/m² cisplatin given intravenously every 3 weeks on days 1, 22 concurrently with radiotherapy.

  • Intensity Modulated Radiation TherapyRadiation

    Also called IMRT

    Patients in both arms received Intensity Modulated Radiation Therapy:All target volumes were outlined slice by slice on the axial contrast-enhanced CT with MR fusion images in the treatment planning system. The target volumes were defined in accordance with the International Commission on Radiation Units and Measurements Reports 83. The prescribed dose was 70-72 Gy to PTVnx (Planning target volume of the primary tumor), 64-70 Gy to PTVnd (Planning target volume of the cervical lymph node),60- 64Gy to PTV1 (Planning target volume 1), and 54-58 Gy to PTV2 (Planning target volume 2) in 30-32 fractions. The details of dose limits for organs at risk were based on the study 0225 from The Radiation Therapy Oncology Group (RTOG 0225).

Study groups in NCT04436965
Study groupRoleWhat they receive
Standard nutrition therapyExperimentalDynamic nutrition assessment will be performed to patients. If malnutrion happened, patients would receive oral nutritional supplements (ONS) first, then feeded with nasal feeding tube or PEG when ONS wasn't enough. If all the these enteral nutrition methods couldn't make up for patient's nutritional deficiencies, parenteral nutrition would be considered.
Receives: Other: Standardized nutrition therapy; Drug: Cisplatin; Radiation: Intensity Modulated Radiation Therapy
Conventional nutrition therapyActive comparatorDynamic nutrition assessment will be performed to patients throughout whole treatment, and symptomatic treatment would be performed if needed.
Receives: Drug: Cisplatin; Radiation: Intensity Modulated Radiation Therapy

What is being measured

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

  1. The incidence of IBW%

    To observe the changes and differences in the incidence of the actual weight/ideal weight (IBW%) less than 90% during the treatment of the two groups of patients

    Measured: 2 months

Secondary outcomes (10)

  1. The incidence of WL、UBW% and BMI

    To observe the changes and differences in the incidence of body weight loss (WL)≥5%/10%, actual body weight/usual body weight (UBW%), body mass index (BMI) before, during and after treatment

    Measured: 36 months

  2. Number of Participants With Abnormal Laboratory Values

    To observe patients' complete blood cell count and blood biochemical examination during the treatment and three years after the treatment.

    Measured: 36 months

  3. Overall survival

    From date of recruited to death

    Measured: 36 months

  4. Progression free survival

    From date of recruited to disease progression

    Measured: 36 months

  5. Locoregional recurrence free survival

    From date of recruited to locoregional recurrence

    Measured: 36 months

  6. Distant metastasis free survival

    From date of recruited to distant metastasis

    Measured: 36 months

  7. Nutrition screening and evaluation

    To observe the changes and differences of nutrition screening and evaluation (NRS2002 and PG-SGA) before, during and after treatment in the two groups

    Measured: 36 months

  8. Quality of life: EuroQoL 5 dimension

    Evaluating with questionnaire of EuroQoL 5 dimension, 5 level health state utility index (EQ-5D-5L)

    Measured: 36 months

  9. Acute toxicities

    Evaluating with CTCAE v5.0

    Measured: through study completion, an average of 2 months

  10. Late toxicity

    assessed with Radiation Therapy Oncology Group radiation morbidity scoring criteria

    Measured: 36 months

Timeline

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

  1. First posted18 Jun 2020
  2. Study start16 Aug 2021
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2029 (estimated)

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
266 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04436965
Sponsor's protocol ID
2019-FXY-348-NPC
Status last verified
May 2026
First submitted
16 Jun 2020
Last updated
11 May 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Standardized nutrition therapy, Cisplatin and Intensity Modulated Radiation Therapy in people with Nasopharyngeal Carcinoma and Nutrition Therapy, run by Sun Yat-sen University at 1 site 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 12 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: looking for participants now, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Contact Jingjing Miao, MD (86-13631355201, miaojingjing90@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence of IBW% (time frame: 2 months). 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 NCT04436965.

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 11 May 2026.

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