Back to resultsEffect of Oral Nutritional Supplements on Body Weight Loss of Patients With Nasopharyngeal Carcinoma
Primary Purpose
Nasopharyngeal Carcinoma, Nutritional Support
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Abbott®Ensure
Intensity Modulated Radiation Therapy
cisplatin
Sponsored by
About this trial
This is an interventional treatment trial for Nasopharyngeal Carcinoma focused on measuring Nasopharyngeal Carcinoma, Nutritional Support, Chemoradiotherapy, Dietary Supplements, Body Weight, Cost-Effectiveness Analysis
Eligibility Criteria
Inclusion Criteria:
- Newly histologic diagnosis of nasopharyngeal carcinoma;
- All genders, range from 18-70 years old;
- Clinical stage II-IVa according to the 8th edition of the Union for International Cancer Control/American Joint Committee on Cancer (UICC/AJCC) staging system;
- Patient-Generated Subjective Nutrition Assessment (PG-SGA) score ≤8;
- Main organ functions test should be satisfied the following conditions: (1) Absolute neutrophil count (ANC) ≥1.5×10^9/L; (2) Platelet (PLT) ≥80×10^9/L; (3) Hemoglobin (Hb) ≥90 g/L; (4) Bilirubin < 1.5 times the upper limit of normal value (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 times the upper limit of normal value; (5) Creatinine < 1.5 times the upper limit of normal value or creatinine clearance rate >60 ml/min.
Exclusion Criteria:
- Patients whose energy intake is less than 60% of the target energy requirement for 3 days or more;
- Have or are suffering from other malignant tumors;
- Refuse concurrent chemoradiotherapy;
- With diabetics, galactosemia, or sever metabolic diseases or endocrine diseases;
- Cannot take oral or enteral nutrition, including intestinal obstruction, severe short bowel syndrome or high output fistula, or with severe digestive system diseases;
- Known allergic reaction to any component of Abbott®Ensure, or severe allergic constitution;
- Pregnant or lactating women;
- With previous or ongoing clinical trials;
- Refuse to sign inform consent form.
Sites / Locations
- Fujian Medical University Union Hospital
- First Affiliated Hospital of Fujian Medical UniversityRecruiting
- Fujian Cancer Hospital
- 900th hospital of the joint logistics team, PLA
- The Nanping First Affiliated Hospital of Fujian Medical UniversityRecruiting
- Quanzhou First Hospital Affiliated to Fujian Medical UniversityRecruiting
- The Second Affiliated Hospital of Fujian Medical UniversityRecruiting
- The First Affiliated Hospital of Xiamen University
- Zhongshan Hospital Xiamen UniversityRecruiting
- Zhangzhou Affiliated Hospital of Fujian Medical University
- Nanfang Hospital of Southern Medical University
- Hunan Cancer Hospital
- Jiangxi Provincial Cancer Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Experimental group
Control group
Arm Description
In addition to conventional dietary instruction and individualized nutritional counselling, patients were given additional ONS (Abbott®Ensure of 55.8 g tid) from the beginning to the end of radiotherapy.
Conventional dietary instruction and individualized nutritional counselling from the beginning to the end of radiotherapy.
Outcomes
Primary Outcome Measures
Incidence of weight loss > 5%
The percentage of patients whose body weight decreased more than 5% over baseline, body weight (in kilograms) are measured at baseline and weekly during the course of radiotherapy
Secondary Outcome Measures
PG-SGA Score
The scores assessed by Patient-Generated Subjective Nutrition Assessment (PG-SGA) at baseline and weekly during the course of radiotherapy
Incidence of participants with grade ≥3 oral mucositis
Incidence of grade 3-4 oral mucositis assessed by CTCAE v5.0, evaluated weekly during radiotherapy
Days of radiotherapy interruption
The number of days that radiotherapy was interrupted due to treatment-related toxicity
Score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 v3.0 (EORTC QLQ-C30 v3.0)
The standard scores assessed by the EORTC QLQ-C30 v3.0 at baseline and the end of radiotherapy.
Increment Cost-Utility Ratio (ICUR）
The Increment cost-utility ratio is used to assess the economics of ONS, which is calculated as incremental cost divided by incremental utility.
Full Information
NCT ID
NCT04823468
First Posted
March 26, 2021
Last Updated
May 16, 2022
Sponsor
Jinsheng Hong
Collaborators
Fujian Cancer Hospital, The Second Affiliated Hospital of Fujian Medical University, The Nanping First Affiliated Hospital of Fujian Medical University, Quanzhou First Hospital Affiliated to Fujian Medical University, Fujian Medical University Union Hospital, Zhangzhou Affiliated Hospital of Fujian Medical University, Hunan Cancer Hospital, Jiangxi Provincial Cancer Hospital, 900th hospital of the joint logistics team, PLA, Nanfang Hospital, Southern Medical University, The First Affiliated Hospital of Xiamen University, Zhongshan Hospital Xiamen University
1. Study Identification
Unique Protocol Identification Number
NCT04823468
Brief Title
Effect of Oral Nutritional Supplements on Body Weight Loss of Patients With Nasopharyngeal Carcinoma
Official Title
Effect of Oral Nutritional Supplements From the Beginning of Radiotherapy on Body Weight Loss of Patients With Nasopharyngeal Carcinoma and Its Cost-effectiveness Analysis: A Prospective Multicenter Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 19, 2021 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jinsheng Hong
Collaborators
Fujian Cancer Hospital, The Second Affiliated Hospital of Fujian Medical University, The Nanping First Affiliated Hospital of Fujian Medical University, Quanzhou First Hospital Affiliated to Fujian Medical University, Fujian Medical University Union Hospital, Zhangzhou Affiliated Hospital of Fujian Medical University, Hunan Cancer Hospital, Jiangxi Provincial Cancer Hospital, 900th hospital of the joint logistics team, PLA, Nanfang Hospital, Southern Medical University, The First Affiliated Hospital of Xiamen University, Zhongshan Hospital Xiamen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Concurrent chemoradiotherapy(CCRT) is the principal treatment for nasopharyngeal carcinoma(NPC). Studies have shown that malnutrition is very common in patients with NPC after chemoradiotherapy. Malnutrition can lead to weight loss, treatment interruption, prolonged stay in hospital, increased treatment costs, reduced tolerance to anti-tumor therapy, reduced quality of life and shortened survival time. Nutritional intervention can improve the nutritional status, reduce treatment-related toxicity and improve the survival of patients with NPC.
The first choice of nutritional intervention is oral nutritional supplements(ONS). Some retrospective studies with small samples have found that early nutritional intervention can reduce weight loss and severe oral mucositis in patients with NPC, compared with late nutritional intervention. Therefore, the investigators proposed the hypothesis that ONS from the beginning of radiotherapy can reduce the nutritional impairment, treatment-related toxicity and treatment costs of patients with NPC, and improve their quality of life. The aim of this multicenter randomized controlled clinical trial is to evaluate the efficacy and cost utility of ONS from the beginning to the end of radiotherapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Carcinoma, Nutritional Support
Keywords
Nasopharyngeal Carcinoma, Nutritional Support, Chemoradiotherapy, Dietary Supplements, Body Weight, Cost-Effectiveness Analysis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
214 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
In addition to conventional dietary instruction and individualized nutritional counselling, patients were given additional ONS (Abbott®Ensure of 55.8 g tid) from the beginning to the end of radiotherapy.
Arm Title
Control group
Arm Type
Other
Arm Description
Conventional dietary instruction and individualized nutritional counselling from the beginning to the end of radiotherapy.
Intervention Type
Dietary Supplement
Intervention Name(s)
Abbott®Ensure
Intervention Description
Abbott®Ensure: 55.8 g each time, three times a day, from the beginning to the end of radiotherapy
Intervention Type
Radiation
Intervention Name(s)
Intensity Modulated Radiation Therapy
Intervention Description
The prescribed dose was 68-76 Gy to Planning target volume of the primary tumor (PTVnx), 66-70 Gy to Planning target volume of the cervical lymph node (PTVnd), 60-64 Gy to planning target volume 1 (PTV1), and 50-54 Gy to planning target volume 2 (PTV2) in 30-33 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
Drug
Intervention Name(s)
cisplatin
Intervention Description
80-100 mg/m² cisplatin given intravenously every 3 weeks concurrently with radiotherapy.
Primary Outcome Measure Information:
Title
Incidence of weight loss > 5%
Description
The percentage of patients whose body weight decreased more than 5% over baseline, body weight (in kilograms) are measured at baseline and weekly during the course of radiotherapy
Time Frame
From time of randomization to the date of radiotherapy ends, up to 7 weeks
Secondary Outcome Measure Information:
Title
PG-SGA Score
Description
The scores assessed by Patient-Generated Subjective Nutrition Assessment (PG-SGA) at baseline and weekly during the course of radiotherapy
Time Frame
From time of randomization to the date of radiotherapy ends, up to 7 weeks
Title
Incidence of participants with grade ≥3 oral mucositis
Description
Incidence of grade 3-4 oral mucositis assessed by CTCAE v5.0, evaluated weekly during radiotherapy
Time Frame
During the course of radiotherapy, up to 7 weeks
Title
Days of radiotherapy interruption
Description
The number of days that radiotherapy was interrupted due to treatment-related toxicity
Time Frame
During the course of radiotherapy, up to 7 weeks
Title
Score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 v3.0 (EORTC QLQ-C30 v3.0)
Description
The standard scores assessed by the EORTC QLQ-C30 v3.0 at baseline and the end of radiotherapy.
Time Frame
From time of randomization to the date of radiotherapy ends, up to 7 weeks
Title
Increment Cost-Utility Ratio (ICUR）
Description
The Increment cost-utility ratio is used to assess the economics of ONS, which is calculated as incremental cost divided by incremental utility.
Time Frame
During the course of chemoradiotherapy, up to 7 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Newly histologic diagnosis of nasopharyngeal carcinoma;
All genders, range from 18-70 years old;
Clinical stage II-IVa according to the 8th edition of the Union for International Cancer Control/American Joint Committee on Cancer (UICC/AJCC) staging system;
Patient-Generated Subjective Nutrition Assessment (PG-SGA) score ≤8;
Main organ functions test should be satisfied the following conditions: (1) Absolute neutrophil count (ANC) ≥1.5×10^9/L; (2) Platelet (PLT) ≥80×10^9/L; (3) Hemoglobin (Hb) ≥90 g/L; (4) Bilirubin < 1.5 times the upper limit of normal value (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 times the upper limit of normal value; (5) Creatinine < 1.5 times the upper limit of normal value or creatinine clearance rate >60 ml/min.
Exclusion Criteria:
Patients whose energy intake is less than 60% of the target energy requirement for 3 days or more;
Have or are suffering from other malignant tumors;
Refuse concurrent chemoradiotherapy;
With diabetics, galactosemia, or sever metabolic diseases or endocrine diseases;
Cannot take oral or enteral nutrition, including intestinal obstruction, severe short bowel syndrome or high output fistula, or with severe digestive system diseases;
Known allergic reaction to any component of Abbott®Ensure, or severe allergic constitution;
Pregnant or lactating women;
With previous or ongoing clinical trials;
Refuse to sign inform consent form.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jinsheng Hong
Phone
+8613799375732
Email
13799375732@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jinsheng Hong
Organizational Affiliation
First Affiliated Hospital of Fujian Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fujian Medical University Union Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350001
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benhua Xu
Phone
13696884375
Email
benhuaxu@163.com
Facility Name
First Affiliated Hospital of Fujian Medical University
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350005
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jinsheng Hong
Phone
+86 13799375732
Email
13799375732@163.com
First Name & Middle Initial & Last Name & Degree
Li Su
Phone
+86 13950396918
Email
lily2230@126.com
Facility Name
Fujian Cancer Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350014
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shaojun Lin
Phone
13860603879
Email
linshaojun@yeah.net
Facility Name
900th hospital of the joint logistics team, PLA
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350025
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhichao Fu
Phone
13774562945
Email
fauster1112@126.com
Facility Name
The Nanping First Affiliated Hospital of Fujian Medical University
City
Nanping
State/Province
Fujian
ZIP/Postal Code
353000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rongqiang Liu
Phone
18960610588
Email
jiniris@163.com
Facility Name
Quanzhou First Hospital Affiliated to Fujian Medical University
City
Quanzhou
State/Province
Fujian
ZIP/Postal Code
362000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zilong Chen
Phone
13505039984
Email
czll1234@163.com
Facility Name
The Second Affiliated Hospital of Fujian Medical University
City
Quanzhou
State/Province
Fujian
ZIP/Postal Code
362000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhigang Bai
Phone
13805969375
Email
drbpc65@126.com
Facility Name
The First Affiliated Hospital of Xiamen University
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361003
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qin Lin
Phone
13806000926
Email
linqin05@163.com
Facility Name
Zhongshan Hospital Xiamen University
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361004
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haijie Lu
Phone
13696982871
Email
luhaijiedr@163.com
Facility Name
Zhangzhou Affiliated Hospital of Fujian Medical University
City
Zhangzhou
State/Province
Fujian
ZIP/Postal Code
363000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianli Huang
Phone
13606959887
Email
zzhuangjl@163.com
Facility Name
Nanfang Hospital of Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jian Guan
Phone
13632102247
Email
51643930@qq.com
Facility Name
Hunan Cancer Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yaqian Han
Phone
18673176667
Email
hanyaqiancs@163.com
Facility Name
Jiangxi Provincial Cancer Hospital
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330029
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaochang Gong
Phone
13970020755
Email
gxcanddw@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Oral Nutritional Supplements on Body Weight Loss of Patients With Nasopharyngeal Carcinoma
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