Back to results

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

Primary Purpose

Nasopharyngeal Carcinoma, Nutrition Therapy

Status

Recruiting

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Standardized nutrition therapy

Cisplatin

Intensity Modulated Radiation Therapy

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

Sun Yat-sen University Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Standard nutrition therapy

Conventional nutrition therapy

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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.

Overall survival

From date of recruited to death

Progression free survival

From date of recruited to disease progression

Locoregional recurrence free survival

From date of recruited to locoregional recurrence

Distant metastasis free survival

From date of recruited to distant metastasis

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

Quality of life: EuroQoL 5 dimension

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

Acute toxicities

Evaluating with CTCAE v5.0

Late toxicity

assessed with Radiation Therapy Oncology Group radiation morbidity scoring criteria

Full Information

NCT ID

NCT04436965

First Posted

June 16, 2020

Last Updated

January 29, 2023

Sponsor

Sun Yat-sen University

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT04436965

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 16, 2021 (Actual)

Primary Completion Date

July 15, 2024 (Anticipated)

Study Completion Date

December 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nasopharyngeal Carcinoma, Nutrition Therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

266 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Standard nutrition therapy

Arm Type

Experimental

Arm Description

Arm Title

Conventional nutrition therapy

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Standardized nutrition therapy

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Other Intervention Name(s)

DDP

Intervention Description

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

Radiation

Intervention Name(s)

Intensity Modulated Radiation Therapy

Other Intervention Name(s)

IMRT

Intervention Description

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).

Primary Outcome Measure Information:

Title

The incidence of IBW%

Description

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

Time Frame

2 months

Secondary Outcome Measure Information:

Title

The incidence of WL、UBW% and BMI

Description

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

Time Frame

36 months

Title

Number of Participants With Abnormal Laboratory Values

Description

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

Time Frame

36 months

Title

Overall survival

Description

From date of recruited to death

Time Frame

36 months

Title

Progression free survival

Description

From date of recruited to disease progression

Time Frame

36 months

Title

Locoregional recurrence free survival

Description

From date of recruited to locoregional recurrence

Time Frame

36 months

Title

Distant metastasis free survival

Description

From date of recruited to distant metastasis

Time Frame

36 months

Title

Nutrition screening and evaluation

Description

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

Time Frame

36 months

Title

Quality of life: EuroQoL 5 dimension

Description

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

Time Frame

36 months

Title

Acute toxicities

Description

Evaluating with CTCAE v5.0

Time Frame

through study completion, an average of 2 months

Title

Late toxicity

Description

assessed with Radiation Therapy Oncology Group radiation morbidity scoring criteria

Time Frame

36 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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;

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jingjing Miao, MD

Phone

86-13631355201

miaojingjing90@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chong Zhao, MD

Organizational Affiliation

Sun Yat-sen University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sun Yat-sen University Cancer Center

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510060

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Chong Zhao, MD

Phone

02087342638

zhaochong@sysucc.org.cn

12. IPD Sharing Statement

Links:

URL

http://www.sysucc.org.cn

Description

Home Page of Cancer Center, Sun Yat-sen University

Learn more about this trial

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

We'll reach out to this number within 24 hrs