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NCT Number: NCT04436965

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location status: Recruiting

Location contact

Chong Zhao, MD

CONTACT

[email protected]

02087342638

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(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;
  • 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;

Exclusion criteria

  • 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;
  • Mental disorder;
  • Pregnancy or lactation;
  • Severe complication, eg, uncontrolled hypertension;

Treatment and study plan

Standardized nutrition therapy

Other

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

Cisplatin

Drug

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

Other names: DDP

Intensity modulated radiation therapy

Radiation

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).

Other names: IMRT

Primary outcomes

  1. The incidence of IBW%

    Time frame: 2 months

    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

Secondary outcomes

  1. The incidence of WL、UBW% and BMI

    Time frame: 36 months

    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

  2. Number of Participants With Abnormal Laboratory Values

    Time frame: 36 months

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

  3. Overall survival

    Time frame: 36 months

    From date of recruited to death

  4. Progression free survival

    Time frame: 36 months

    From date of recruited to disease progression

  5. Locoregional recurrence free survival

    Time frame: 36 months

    From date of recruited to locoregional recurrence

  6. Distant metastasis free survival

    Time frame: 36 months

    From date of recruited to distant metastasis

  7. Nutrition screening and evaluation

    Time frame: 36 months

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

  8. Quality of life: EuroQoL 5 dimension

    Time frame: 36 months

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

  9. Acute toxicities

    Time frame: through study completion, an average of 2 months

    Evaluating with CTCAE v5.0

  10. Late toxicity

    Time frame: 36 months

    assessed with Radiation Therapy Oncology Group radiation morbidity scoring criteria

Study contacts

Contact information is provided by the study sponsor or research team.

Jingjing Miao, MD

CONTACT

[email protected]

86-13631355201

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Collaborators

  • Cancer Hospital of Guizhou Province
  • Fudan University
  • Fujian Cancer Hospital
  • Jiangxi Provincial Cancer Hospital
  • The First Affiliated Hospital of Xiamen University
  • Xiangya Hospital of Central South University
  • Xijing Hospital
  • Zhejiang Cancer Hospital
  • Zhongnan Hospital

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2026
Study completion
2029
First posted
Jun 18, 2020
Registry last updated
May 11, 2026

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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