Trial Title:
Effect of Immunonutrients on Oral Mucositis in Nasopharyngeal Carcinoma Patients After Chemoradiotherapy
NCT ID:
NCT05892354
Condition:
Locally Advanced Nasopharyngeal Carcinoma
Conditions: Official terms:
Carcinoma
Nasopharyngeal Carcinoma
Mucositis
Stomatitis
Conditions: Keywords:
Immunonutrition
Nasopharyngeal Carcinoma
Chemoradiotherapy
Oral Mucositis
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Dietary Supplement
Intervention name:
Enteral immunonutrition
Description:
Enteral immunonutrition (Oral Impact®, Nestle), 250ml/ bottle, 2 bottles per day, from 5
days before radiotherapy to the end of radiotherapy.
Arm group label:
Immunonutrition Group
Intervention type:
Dietary Supplement
Intervention name:
Standard enteral nutrition
Description:
Isocaloric standard enteral nutrition formula (ENSURE®)， 250 mL per administration, 3
times per day. Preparation of the 250 mL dose involves adding 200 mL of potable water to
a cup and slowly stirring in 52.7 g of ENSURE powder (approximately 6 scoops).
Arm group label:
Control Group
Summary:
The purpose of this study was to investigate the role of immunonutrion compared with
standard nutrition in reducing oral mucositis in patients with locally advanced
nasopharyngeal carcinoma.
Detailed description:
Oral mucositis is the most common adverse reaction in patients with nasopharyngeal
carcinoma receiving chemoradiotherapy, of which 40-50% of patients are severe (grade
3-4). Oral mucositis usually results in pain, dysphagia, reduced feeding, and
malnutrition. Severe malnutrition in turn increases the risk of severe oral mucositis.
Persistent severe oral mucositis will lead to delay and interruption of treatment,
impairing patients'quality of life and prognosis. It's reported that nutritional
intervention can not only reduce the risk and severity of oral mucositis and improve the
nutritional status of patients with head and neck tumors, but also improve patients'
tolerance to radiotherapy, quality of life, and prognosis.
Immunonutrition refers to the addition of high content of immune nutrients on the basis
of sufficient calories, which not only ensures the supply of nutrition, but also takes
into account the effects of anti-inflammation, regulating immunity, improving treatment
tolerance, improving prognosis and so on. It has been reported that, comparing with
standard enteral nutrition, the incidence of severe oral mucositis and esophagitis in
patients with head and neck tumors treated with immunonutrition was lower, suffering less
weight loss, and the antitumor immune response was enhanced. The 3-year OS and PFS were
significantly improved in patients with good compliance.
It remains to be seen whether or not NPC patients receiving chemoradiotherapy can be
benifit from immunonutritional therapy. Therefore, we conducted a prospective,
multi-center, randomized controlled clinical study in patients with nasopharyngeal
carcinoma who received radiotherapy and chemotherapy without metastases, to further
improve the quality of life and prognosis of patients with nasopharyngeal carcinoma.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
2. Age 18-70 years old, male or non-pregnant women;
3. Pathologically confirmed non-keratinizing carcinoma of the nasopharynx
(differentiated or undifferentiated,WHO type II or III);
4. Newly diagnosed stage III-IVa (8th AJCC/UICC stage) NPC patients;
5. The levels of major organ function meet the following criteria:
(1)Hematology: WBC ≥ 3.0 × 10^9/L, ANC ≥ 1.5 × 10^9/L, PLT ≥ 100 × 10^9/L, HGB ≥ 90 g/L;
(2) Liver function: ALT, AST≤2.5 times the upper limit of normal (ULN), total bilirubin ≤
1.5 × ULN; (3) Renal function: BUN and CRE ≤ 1.5 × ULN or an estimated glomerular
filtration rate (eGFR) ≥ 60 ml/min (calculated using the Cockcroft-Gault equation); (4)
Adequate coagulation function: defined as an international normalized ratio (INR) or
prothrombin time (PT) ≤ 1.5 times the ULN; (5) Normal levels of cardiac enzymes; 6. The
patient has signed informed consent forms and is able to comply with the study's planned
visits, treatment plans, and laboratory tests.
Exclusion Criteria:
1. History of investigational Oral Impact®/ENSURE® use within the month prior to
enrollment;
2. Known allergy or intolerance to any component of investigational Oral
Impact®/ENSURE® or related chemotherapy drugs;
3. Poor glycemic control in patients with diabetes;
4. Patients with autoimmune diseases;
5. Patients with active infections;
6. Patients who have received radiation therapy or other anti-tumor treatments in the
past;
7. Patients with a history of other malignant tumors;
8. Presence of oral mucositis at baseline;
9. Malnutrition at baseline;
10. Patients who cannot eat the required amount of food at baseline and require
parenteral or enteral nutrition;
11. Inability to eat soft solid foods at baseline;
12. History of human immunodeficiency virus (HIV) or active hepatitis B/C virus
infection;
13. Participation in other intervention clinical studies within one month;
14. Subjects deemed by the investigator to have other factors that may force them to
terminate the study, such as having other serious illnesses (including mental
illnesses) that require concomitant treatment, significantly abnormal laboratory
test results, or family or social factors that may affect subject safety or data
collection.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fujian Provincial Hospital
Address:
City:
Fuzhou
Zip:
350000
Country:
China
Status:
Recruiting
Contact:
Last name:
Jingbo Chen, MD
Phone:
+86 591 8821 8888
Email:
13635294192@163.com
Facility:
Name:
Fujian Cancer Hospital
Address:
City:
Fuzhou
Zip:
350014
Country:
China
Status:
Recruiting
Contact:
Last name:
Yun Xu, MD
Email:
308466040@qq.com
Facility:
Name:
Guangdong Provincial People's Hospital
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Contact:
Last name:
Dehuan Xie, MD
Phone:
+86 20 8382 7812
Email:
xiedehuan@gdph.org.cn
Facility:
Name:
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Address:
City:
Guangzhou
Zip:
510070
Country:
China
Status:
Recruiting
Contact:
Last name:
Mingyi Li, MD
Phone:
+86 20 8359 5032
Facility:
Name:
Huizhou Municipal Central Hospital
Address:
City:
Huizhou
Zip:
516001
Country:
China
Status:
Recruiting
Contact:
Last name:
Ying Shao, MD
Phone:
+86 752 217 8126
Email:
shaoying8718@163.com
Facility:
Name:
The First Affiliated Hospital of Guangxi Medical University
Address:
City:
Nanning
Zip:
530000
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhen Meng, M.D
Phone:
07715356509
Email:
mengzhen0307@163.com
Contact backup:
Last name:
Yating Qin, M.D
Phone:
07715356509
Email:
937125122@qq.com
Facility:
Name:
The Affiliated Hospital of Guilin Medical University
Address:
City:
Guilin
Zip:
541001
Country:
China
Status:
Recruiting
Contact:
Last name:
Meilian Liu
Phone:
+86 773 283 3086
Facility:
Name:
Liuzhou Workers Hospital
Address:
City:
Liuzhou
Zip:
545025
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhuohua Xu, MS
Facility:
Name:
Wuzhou Red Cross Hospital
Address:
City:
Wuzhou
Zip:
543002
Country:
China
Status:
Recruiting
Contact:
Last name:
Lingling Fan, MS
Phone:
+86 774 382 3120
Facility:
Name:
First People People's Hospital of Yulin City
Address:
City:
Yulin
Zip:
537001
Country:
China
Status:
Recruiting
Contact:
Last name:
Leifeng Liang, MD
Facility:
Name:
Red Cross Hospital of Yulin City
Address:
City:
Yulin
Zip:
537006
Country:
China
Status:
Recruiting
Contact:
Last name:
Shuang Li, MS
Phone:
+86 774 382 3120
Facility:
Name:
Huizhou Municipal Central Hospital
Address:
City:
Haikou
Zip:
570208
Country:
China
Status:
Recruiting
Contact:
Last name:
Feng Yuan, MD
Phone:
+86 898 6615 1001
Facility:
Name:
The Second Affiliated Hospital of Hainan Medical University
Address:
City:
Haikou
Zip:
570311
Country:
China
Status:
Recruiting
Contact:
Last name:
Junnv Xu, MD
Phone:
+86 898 6680 9130
Facility:
Name:
Hainan Cancer Hospital
Address:
City:
Haikou
Zip:
570314
Country:
China
Status:
Recruiting
Contact:
Last name:
Pingting Zhou, MD
Phone:
+86 898 6855 2139
Email:
18689525165@163.com
Facility:
Name:
Second Affiliated Hospital of Nanchang University
Address:
City:
Nanchang
Zip:
330000
Country:
China
Status:
Recruiting
Contact:
Last name:
Jianwu Ding, MD
Phone:
+86 791 8629 7662
Facility:
Name:
The First Affiliated Hospital of Nanchang University
Address:
City:
Nanchang
Zip:
330209
Country:
China
Status:
Recruiting
Contact:
Last name:
Shaoqing Chen, MD
Email:
7687105701@qq.com
Facility:
Name:
Qingdao Central Hospital
Address:
City:
Qingdao
Zip:
266044
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaotao Zhang, MD
Facility:
Name:
Zhejiang Provincial Tongde Hospital
Address:
City:
Hangzhou
Zip:
310012
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhongzhu Tang, MD
Phone:
+86 571 8992 0000
Facility:
Name:
Zhejiang Provincial People's Hospital
Address:
City:
Hangzhou
Zip:
310014
Country:
China
Status:
Recruiting
Contact:
Last name:
limin Luo, MD
Email:
21259400@qq.com
Facility:
Name:
Zhejiang Cancer Hospital
Address:
City:
Hangzhou
Zip:
310022
Country:
China
Status:
Recruiting
Contact:
Last name:
Yonghong Hua, MD
Phone:
+86 571 8812 8218
Email:
nc.gro.ccjz@yquh.com
Start date:
June 12, 2023
Completion date:
April 1, 2027
Lead sponsor:
Agency:
First Affiliated Hospital of Guangxi Medical University
Agency class:
Other
Collaborator:
Agency:
Guangdong Provincial People's Hospital
Agency class:
Other
Collaborator:
Agency:
Zhejiang Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
Zhejiang Provincial People's Hospital
Agency class:
Other
Collaborator:
Agency:
Fujian Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
Fujian Provincial Hospital
Agency class:
Other
Collaborator:
Agency:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Agency class:
Other
Collaborator:
Agency:
The First Affiliated Hospital of Nanchang University
Agency class:
Other
Collaborator:
Agency:
Second Affiliated Hospital of Nanchang University
Agency class:
Other
Collaborator:
Agency:
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Agency class:
Other
Collaborator:
Agency:
Qingdao Central Hospital
Agency class:
Other
Collaborator:
Agency:
Huizhou Municipal Central Hospital
Agency class:
Other
Collaborator:
Agency:
Haikou People's Hospital
Agency class:
Other
Collaborator:
Agency:
The Second Affiliated Hospital of Hainan Medical University
Agency class:
Other
Collaborator:
Agency:
Zhejiang Provincial Tongde Hospital
Agency class:
Other
Collaborator:
Agency:
Guilin Medical University, China
Agency class:
Other
Collaborator:
Agency:
Liuzhou Workers Hospital
Agency class:
Other
Collaborator:
Agency:
Wuzhou Red Cross Hospital
Agency class:
Other
Collaborator:
Agency:
Red Cross Hospital of Yulin City
Agency class:
Other
Collaborator:
Agency:
First People's Hospital of Yulin
Agency class:
Other
Collaborator:
Agency:
Hainan Cancer Hospital
Agency class:
Other
Source:
First Affiliated Hospital of Guangxi Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05892354
