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

Nasopharyngeal Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04436965
• Other study ID #: 2019-FXY-348-NPC
• Status: Recruiting
• Phase: Phase 3
• Start date: August 16, 2021
• Est. completion date: December 15, 2024

Study information

• Verified date: January 2023
• Source: Sun Yat-sen University
• Contact: Jingjing Miao, MD
• Phone: 86-13631355201
• Email: miaojingjing90[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 266
• Est. completion date: December 15, 2024
• Est. primary completion date: July 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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;

Related Conditions & MeSH terms

• Carcinoma
• Malnutrition
• Nasopharyngeal Carcinoma
• Nutrition Therapy

Intervention

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

Drug:
• 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.

Radiation:
• 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).

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (10)

Lead Sponsor	Collaborator
Sun Yat-sen University	Cancer Hospital of Guizhou Province, Fudan University, Fujian Cancer Hospital, Jiangxi Provincial Cancer Hospital, The First Affiliated Hospital of Xiamen University, Wuhan University, Xiangya Hospital of Central South University, Xijing Hospital, Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	36 months
Secondary	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.	36 months
Secondary	Overall survival	From date of recruited to death	36 months
Secondary	Progression free survival	From date of recruited to disease progression	36 months
Secondary	Locoregional recurrence free survival	From date of recruited to locoregional recurrence	36 months
Secondary	Distant metastasis free survival	From date of recruited to distant metastasis	36 months
Secondary	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	36 months
Secondary	Quality of life: EuroQoL 5 dimension	Evaluating with questionnaire of EuroQoL 5 dimension, 5 level health state utility index (EQ-5D-5L)	36 months
Secondary	Acute toxicities	Evaluating with CTCAE v5.0	through study completion, an average of 2 months
Secondary	Late toxicity	assessed with Radiation Therapy Oncology Group radiation morbidity scoring criteria	36 months

External Links

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