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

NCT04436965 | Unknown Phase 3

• 1 other identifier: 2019-FXY-348-NPC
• Study Type: interventional
• Target: 266
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nasopharyngeal Carcinoma; Nutrition Therapy

Outcome Measures

Primary Outcomes (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

  2 months

Secondary Outcomes (10)

• The incidence of WL、UBW% and BMI

  36 months

• Number of Participants With Abnormal Laboratory Values

  36 months

• Overall survival

  36 months

• Progression free survival

  36 months

• Locoregional recurrence free survival

  36 months

Study Arms (2)

Standard nutrition therapy

EXPERIMENTAL

Dynamic 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.

Other: Standardized nutrition therapy; Drug: Cisplatin; Radiation: Intensity Modulated Radiation Therapy

Conventional nutrition therapy

ACTIVE COMPARATOR

Dynamic nutrition assessment will be performed to patients throughout whole treatment, and symptomatic treatment would be performed if needed.

Drug: Cisplatin; Radiation: Intensity Modulated Radiation Therapy

Interventions

Standardized nutrition therapy OTHER

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

Standard nutrition therapy

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.

Also known as: DDP

Conventional nutrition therapy; Standard nutrition therapy

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).

Also known as: IMRT

Conventional nutrition therapy; Standard nutrition therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Wuhan University: collaborator
• The First Affiliated Hospital of Xiamen University: collaborator
• Fudan University: collaborator
• Jiangxi Provincial Cancer Hospital: collaborator
• Xijing Hospital: collaborator
• Xiangya Hospital of Central South University: collaborator
• Fujian Cancer Hospital: collaborator
• Zhejiang Cancer Hospital: collaborator
• Cancer Hospital of Guizhou Province: collaborator

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Related Links

• Home Page of Cancer Center, Sun Yat-sen University

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Cisplatin; Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• Chong Zhao, MD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jingjing Miao, MD

CONTACT

86-13631355201; miaojingjing90@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: June 16, 2020
• First Posted: June 18, 2020
• Study Start: August 16, 2021
• Primary Completion: July 15, 2024
• Study Completion: December 15, 2024
• Last Updated: January 31, 2023

Record last verified: 2023-01

Locations

CN (1)