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

NCT ID: NCT04436965

Last Updated: 2023-01-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 266 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-16
• Study Completion Date: 2024-12-15

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard nutrition therapy

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.

Group Type: EXPERIMENTAL

Standardized nutrition therapy

Intervention Type: OTHER

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

Cisplatin

Intervention Type: 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.

Intensity Modulated Radiation Therapy

Intervention Type: 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).

Conventional nutrition therapy

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

Group Type: ACTIVE_COMPARATOR

Cisplatin

Intervention Type: 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.

Intensity Modulated Radiation Therapy

Intervention Type: 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).

Interventions

Standardized nutrition therapy

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

Intervention Type: OTHER

Cisplatin

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

Intervention Type: DRUG

Intensity Modulated Radiation Therapy

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).

Intervention Type: RADIATION

Other Intervention Names

DDP; IMRT

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wuhan University

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital of Xiamen University

OTHER

Sponsor Role: collaborator

Fudan University

OTHER

Sponsor Role: collaborator

Jiangxi Provincial Cancer Hospital

OTHER

Sponsor Role: collaborator

Xijing Hospital

OTHER

Sponsor Role: collaborator

Xiangya Hospital of Central South University

OTHER

Sponsor Role: collaborator

Fujian Cancer Hospital

OTHER_GOV

Sponsor Role: collaborator

Zhejiang Cancer Hospital

OTHER

Sponsor Role: collaborator

Cancer Hospital of Guizhou Province

OTHER

Sponsor Role: collaborator

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Zhao Chong

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chong Zhao, MD

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jingjing Miao, MD

Role: CONTACT

miaojingjing90@163.com

86-13631355201

Facility Contacts

Chong Zhao, MD

Role: primary

zhaochong@sysucc.org.cn

02087342638

Related Links

http://www.sysucc.org.cn

Home Page of Cancer Center, Sun Yat-sen University

Other Identifiers

2019-FXY-348-NPC

Identifier Type: -

Identifier Source: org_study_id