Effect of Immunonutrients on Oral Mucositis in Nasopharyngeal Carcinoma Patients After Chemoradiotherapy
NCT ID: NCT05892354
Last Updated: 2024-08-07
Study Results
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Basic Information
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RECRUITING
NA
190 participants
INTERVENTIONAL
2023-06-12
2027-04-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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).
Standard enteral nutrition
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).
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.
Enteral immunonutrition
Enteral immunonutrition (Oral Impact®, Nestle), 250ml/ bottle, 2 bottles per day, from 5 days before radiotherapy to the end of radiotherapy.
Interventions
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Enteral immunonutrition
Enteral immunonutrition (Oral Impact®, Nestle), 250ml/ bottle, 2 bottles per day, from 5 days before radiotherapy to the end of radiotherapy.
Standard enteral nutrition
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).
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
70 Years
ALL
No
Sponsors
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Guangdong Provincial People's Hospital
OTHER
Zhejiang Cancer Hospital
OTHER
Zhejiang Provincial People's Hospital
OTHER
Fujian Cancer Hospital
OTHER_GOV
Fujian Provincial Hospital
OTHER
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
OTHER
The First Affiliated Hospital of Nanchang University
OTHER
Second Affiliated Hospital of Nanchang University
OTHER
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
OTHER
Qingdao Central Hospital
OTHER
Huizhou Municipal Central Hospital
OTHER
Haikou People's Hospital
OTHER
The Second Affiliated Hospital of Hainan Medical University
OTHER
Zhejiang Provincial Tongde Hospital
OTHER
Guilin Medical University, China
OTHER
Liuzhou Workers' Hospital
OTHER_GOV
Wuzhou Red Cross Hospital
OTHER
Red Cross Hospital of Yulin City
OTHER
First People's Hospital of Yulin
OTHER
Hainan Cancer Hospital
OTHER
First Affiliated Hospital of Guangxi Medical University
OTHER
Responsible Party
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min kang
Professor
Principal Investigators
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Min Kang, M.D
Role: STUDY_CHAIR
Department of Radiation Oncology, The First Affiliated Hospital of Guangxi Medical University
Locations
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Fujian Provincial Hospital
Fuzhou, Fujian, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Guangzhou, Guangdong, China
Huizhou Municipal Central Hospital
Huizhou, Guangdong, China
The Affiliated Hospital of Guilin Medical University
Guilin, Guangxi, China
Liuzhou Workers Hospital
Liuzhou, Guangxi, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
Wuzhou Red Cross Hospital
Wuzhou, Guangxi, China
First People People's Hospital of Yulin City
Yulin, Guangxi, China
Red Cross Hospital of Yulin City
Yulin, Guangxi, China
Huizhou Municipal Central Hospital
Haikou, Hainan, China
The Second Affiliated Hospital of Hainan Medical University
Haikou, Hainan, China
Hainan Cancer Hospital
Haikou, Hainan, China
Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Qingdao Central Hospital
Qingdao, Shandong, China
Zhejiang Provincial Tongde Hospital
Hangzhou, Zhejiang, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Mingyi Li, MD
Role: primary
Meilian Liu
Role: primary
Zhuohua Xu, MS
Role: primary
Lingling Fan, MS
Role: primary
Leifeng Liang, MD
Role: primary
Shuang Li, MS
Role: primary
Feng Yuan, MD
Role: primary
Junnv Xu, MD
Role: primary
Jianwu Ding, MD
Role: primary
Xiaotao Zhang, MD
Role: primary
Zhongzhu Tang, MD
Role: primary
References
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Moslemi D, Nokhandani AM, Otaghsaraei MT, Moghadamnia Y, Kazemi S, Moghadamnia AA. Management of chemo/radiation-induced oral mucositis in patients with head and neck cancer: A review of the current literature. Radiother Oncol. 2016 Jul;120(1):13-20. doi: 10.1016/j.radonc.2016.04.001. Epub 2016 Apr 21.
Liang L, Liu Z, Zhu H, Wang H, Wei Y, Ning X, Shi Z, Jiang L, Lin Z, Yan H, Wang R, Hu K. Efficacy and safety of thalidomide in preventing oral mucositis in patients with nasopharyngeal carcinoma undergoing concurrent chemoradiotherapy: A multicenter, open-label, randomized controlled trial. Cancer. 2022 Apr 1;128(7):1467-1474. doi: 10.1002/cncr.34074. Epub 2021 Dec 15.
Xia C, Jiang C, Li W, Wei J, Hong H, Li J, Feng L, Wei H, Xin H, Chen T. A Phase II Randomized Clinical Trial and Mechanistic Studies Using Improved Probiotics to Prevent Oral Mucositis Induced by Concurrent Radiotherapy and Chemotherapy in Nasopharyngeal Carcinoma. Front Immunol. 2021 Mar 24;12:618150. doi: 10.3389/fimmu.2021.618150. eCollection 2021.
Miyata H, Yano M, Yasuda T, Yamasaki M, Murakami K, Makino T, Nishiki K, Sugimura K, Motoori M, Shiraishi O, Mori M, Doki Y. Randomized study of the clinical effects of omega-3 fatty acid-containing enteral nutrition support during neoadjuvant chemotherapy on chemotherapy-related toxicity in patients with esophageal cancer. Nutrition. 2017 Jan;33:204-210. doi: 10.1016/j.nut.2016.07.004. Epub 2016 Jul 25.
Shu Z, Zeng Z, Yu B, Huang S, Hua Y, Jin T, Tao C, Wang L, Cao C, Xu Z, Jin Q, Jiang F, Feng X, Piao Y, Huang J, Chen J, Shen W, Chen X, Wu H, Wang X, Qiu R, Lu L, Chen Y. Nutritional Status and Its Association With Radiation-Induced Oral Mucositis in Patients With Nasopharyngeal Carcinoma During Radiotherapy: A Prospective Study. Front Oncol. 2020 Nov 6;10:594687. doi: 10.3389/fonc.2020.594687. eCollection 2020.
Kabarriti R, Bontempo A, Romano M, McGovern KP, Asaro A, Viswanathan S, Kalnicki S, Garg MK. The impact of dietary regimen compliance on outcomes for HNSCC patients treated with radiation therapy. Support Care Cancer. 2018 Sep;26(9):3307-3313. doi: 10.1007/s00520-018-4198-x. Epub 2018 Apr 18.
Zheng Z, Zhao X, Zhao Q, Zhang Y, Liu S, Liu Z, Meng L, Xin Y, Jiang X. The Effects of Early Nutritional Intervention on Oral Mucositis and Nutritional Status of Patients With Head and Neck Cancer Treated With Radiotherapy. Front Oncol. 2021 Feb 1;10:595632. doi: 10.3389/fonc.2020.595632. eCollection 2020.
Boisselier P, Kaminsky MC, Thezenas S, Gallocher O, Lavau-Denes S, Garcia-Ramirez M, Alfonsi M, Cupissol D, de Forges H, Janiszewski C, Geoffrois L, Sire C, Senesse P; Head and Neck Oncology and Radiotherapy Group (GORTEC). A double-blind phase III trial of immunomodulating nutritional formula during adjuvant chemoradiotherapy in head and neck cancer patients: IMPATOX. Am J Clin Nutr. 2020 Dec 10;112(6):1523-1531. doi: 10.1093/ajcn/nqaa227.
Talvas J, Garrait G, Goncalves-Mendes N, Rouanet J, Vergnaud-Gauduchon J, Kwiatkowski F, Bachmann P, Bouteloup C, Bienvenu J, Vasson MP. Immunonutrition stimulates immune functions and antioxidant defense capacities of leukocytes in radiochemotherapy-treated head & neck and esophageal cancer patients: A double-blind randomized clinical trial. Clin Nutr. 2015 Oct;34(5):810-7. doi: 10.1016/j.clnu.2014.12.002. Epub 2014 Dec 9.
Dechaphunkul T, Arundon T, Raungkhajon P, Jiratrachu R, Geater SL, Dechaphunkul A. Benefits of immunonutrition in patients with head and neck cancer receiving chemoradiation: A phase II randomized, double-blind study. Clin Nutr. 2022 Feb;41(2):433-440. doi: 10.1016/j.clnu.2021.12.035. Epub 2021 Dec 28.
Other Identifiers
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FirstGuangxiMu3
Identifier Type: -
Identifier Source: org_study_id
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