Nasopharyngeal Carcinoma Clinical Trials

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Efficacy of Immunonutrients in Reducing Oral Mucositis in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma: A Prospective, Multicenter, Randomized Controlled Clinical Trial

Status: Recruiting
Location: See all (20) locations...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Eastern Cooperative Oncology Group (ECOG) performance status 0-1;

• Age 18-70 years old, male or non-pregnant women;

• Pathologically confirmed non-keratinizing carcinoma of the nasopharynx (differentiated or undifferentiated,WHO type II or III);

• Newly diagnosed stage III-IVa (8th AJCC/UICC stage) NPC patients;

• 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.

Locations
Other Locations
China
Fujian Cancer Hospital
RECRUITING
Fuzhou
Fujian Provincial Hospital
RECRUITING
Fuzhou
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
RECRUITING
Guangzhou
Guangdong Provincial People's Hospital
RECRUITING
Guangzhou
The Affiliated Hospital of Guilin Medical University
RECRUITING
Guilin
Hainan Cancer Hospital
RECRUITING
Haikou
Huizhou Municipal Central Hospital
RECRUITING
Haikou
The Second Affiliated Hospital of Hainan Medical University
RECRUITING
Haikou
Zhejiang Cancer Hospital
RECRUITING
Hangzhou
Zhejiang Provincial People's Hospital
RECRUITING
Hangzhou
Zhejiang Provincial Tongde Hospital
RECRUITING
Hangzhou
Huizhou Municipal Central Hospital
RECRUITING
Huizhou
Liuzhou Workers Hospital
RECRUITING
Liuzhou
Second Affiliated Hospital of Nanchang University
RECRUITING
Nanchang
The First Affiliated Hospital of Nanchang University
RECRUITING
Nanchang
The First Affiliated Hospital of Guangxi Medical University
RECRUITING
Nanning
Qingdao Central Hospital
RECRUITING
Qingdao
Wuzhou Red Cross Hospital
RECRUITING
Wuzhou
First People People's Hospital of Yulin City
RECRUITING
Yulin
Red Cross Hospital of Yulin City
RECRUITING
Yulin
Contact Information
Primary
Zhen Meng, M.D
mengzhen0307@163.com
86-771-5356509
Backup
Yating Qin, M.D
qyt201680138@163.com
86-771-5356509
Time Frame
Start Date: 2023-06-12
Estimated Completion Date: 2027-04-01
Participants
Target number of participants: 190
Treatments
Experimental: Immunonutrition Group
Induction chemotherapy (IC) + Concurrent chemoradiotherapy (CCRT) and enteral immunonutrition~Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for 2-3 cycles before radiotherapy and then receive intensity modulated-radiotherapy (IMRT), concurrently with cisplatin (100mg/m² d1) every 3 weeks for 2-3 cycles.~Patients receive enteral immunonutrition, Oral Impact®, Nestle, 250ml/ bottle, 2 bottles per day, from 5 days before radiotherapy to the end of radiotherapy.
Active_comparator: Control Group
Induction chemotherapy+Concurrent chemoradiotherapy and standard enteral nutrition~Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for 2-3 cycles before radiotherapy and then receive intensity modulated-radiotherapy (IMRT), concurrently with cisplatin(100mg/m² d1) every 3 weeks for 2-3 cycles.~Patients receive isocaloric standard enteral nutrition formula (ENSURE®), 250 mL per administration, 3 times per day, from 5 days before radiotherapy to the end of radiotherapy. 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).
Sponsors
Collaborators: Zhejiang Provincial People's Hospital, Fujian Provincial Hospital, Wuzhou Red Cross Hospital, The First Affiliated Hospital of Nanchang University, The Second Affiliated Hospital of Hainan Medical University, Haikou People's Hospital, Hainan Cancer Hospital, Qingdao Central Hospital, Second Affiliated Hospital of Nanchang University, Huizhou Municipal Central Hospital, Red Cross Hospital of Yulin City, Zhejiang Cancer Hospital, Guangdong Provincial People's Hospital, Liuzhou Workers' Hospital, Guilin Medical University, China, Zhejiang Provincial Tongde Hospital, Fujian Cancer Hospital, First People's Hospital of Yulin, Affiliated Cancer Hospital & Institute of Guangzhou Medical University, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Leads: First Affiliated Hospital of Guangxi Medical University

This content was sourced from clinicaltrials.gov