Effect of Immunonutrients on Oral Mucositis in Nasopharyngeal Carcinoma Patients After Chemoradiotherapy

NCT05892354 | Recruiting

• 1 other identifier: FirstGuangxiMu3
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 20

Brief 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.

Conditions

Locally Advanced Nasopharyngeal Carcinoma

Keywords

Immunonutrition; Nasopharyngeal Carcinoma; Chemoradiotherapy; Oral Mucositis

Outcome Measures

Primary Outcomes (1)

• The incidence of severe oral mucositis

  Incidence of grade 3-4 oral mucositis

  7 weeks

Secondary Outcomes (18)

• The latency period of severe oral mucositis

  7 weeks

• The duration period of severe oral mucositis

  7 weeks

• Assessment of immune state

  4 months

• Serum hypersensitive C-reactive protein (hsCRP) level

  4 months

• Serum Interleukin-6 (IL-6) level

  4 months

Study Arms (2)

Immunonutrition Group

EXPERIMENTAL

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.

Dietary Supplement: Enteral immunonutrition

Control Group

ACTIVE COMPARATOR

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).

Dietary Supplement: Standard enteral nutrition

Interventions

Enteral immunonutrition DIETARY_SUPPLEMENT

Enteral immunonutrition (Oral Impact®, Nestle), 250ml/ bottle, 2 bottles per day, from 5 days before radiotherapy to the end of radiotherapy.

Immunonutrition Group

Standard enteral nutrition DIETARY_SUPPLEMENT

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).

Control Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• History of investigational Oral Impact®/ENSURE® use within the month prior to enrollment;
• Known allergy or intolerance to any component of investigational Oral Impact®/ENSURE® or related chemotherapy drugs;
• Poor glycemic control in patients with diabetes;
• Patients with autoimmune diseases;
• Patients with active infections;
• Patients who have received radiation therapy or other anti-tumor treatments in the past;
• Patients with a history of other malignant tumors;
• Presence of oral mucositis at baseline;
• Malnutrition at baseline;
• Patients who cannot eat the required amount of food at baseline and require parenteral or enteral nutrition;
• Inability to eat soft solid foods at baseline;
• History of human immunodeficiency virus (HIV) or active hepatitis B/C virus infection;
• Participation in other intervention clinical studies within one month;
• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Guangxi Medical University: lead
• Guangdong Provincial People's Hospital: collaborator
• Zhejiang Cancer Hospital: collaborator
• Zhejiang Provincial People's Hospital: collaborator
• Fujian Cancer Hospital: collaborator
• Fujian Provincial Hospital: collaborator
• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: collaborator
• The First Affiliated Hospital of Nanchang University: collaborator
• Second Affiliated Hospital of Nanchang University: collaborator
• Affiliated Cancer Hospital & Institute of Guangzhou Medical University: collaborator
• Qingdao Central Hospital: collaborator
• Huizhou Municipal Central Hospital: collaborator
• Haikou People's Hospital: collaborator
• The Second Affiliated Hospital of Hainan Medical University: collaborator
• Zhejiang Provincial Tongde Hospital: collaborator
• Guilin Medical University, China: collaborator
• Liuzhou Workers' Hospital: collaborator
• Wuzhou Red Cross Hospital: collaborator
• Red Cross Hospital of Yulin City: collaborator
• First People's Hospital of Yulin: collaborator
• Hainan Cancer Hospital: collaborator

Study Sites (20)

Fujian Provincial Hospital

Fuzhou, Fujian, 350000, China

RECRUITING

Fujian Cancer Hospital

Fuzhou, Fujian, 350014, China

RECRUITING

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510060, China

RECRUITING

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Guangzhou, Guangdong, 510070, China

RECRUITING

Huizhou Municipal Central Hospital

Huizhou, Guangdong, 516001, China

RECRUITING

The Affiliated Hospital of Guilin Medical University

Guilin, Guangxi, 541001, China

RECRUITING

Liuzhou Workers Hospital

Liuchow, Guangxi, 545025, China

RECRUITING

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, 530000, China

RECRUITING

Wuzhou Red Cross Hospital

Wuzhou, Guangxi, 543002, China

RECRUITING

First People People's Hospital of Yulin City

Yulin, Guangxi, 537001, China

RECRUITING

Red Cross Hospital of Yulin City

Yulin, Guangxi, 537006, China

RECRUITING

Huizhou Municipal Central Hospital

Haikou, Hainan, 570208, China

RECRUITING

The Second Affiliated Hospital of Hainan Medical University

Haikou, Hainan, 570311, China

RECRUITING

Hainan Cancer Hospital

Haikou, Hainan, 570314, China

RECRUITING

Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330000, China

RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330209, China

RECRUITING

Qingdao Central Hospital

Qingdao, Shandong, 266044, China

RECRUITING

Zhejiang Provincial Tongde Hospital

Hangzhou, Zhejiang, 310012, China

RECRUITING

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, 310014, China

RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

Related Publications (10)

• 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.

  PMID: 27113797 BACKGROUND

• 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.

  PMID: 34910297 BACKGROUND

• 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.

  PMID: 33841399 BACKGROUND

• 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.

  PMID: 27644137 BACKGROUND

• 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.

  PMID: 33240818 BACKGROUND

• 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.

  PMID: 29671062 BACKGROUND

• 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.

  PMID: 33598427 BACKGROUND

• 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.

  PMID: 32936874 BACKGROUND

• 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.

  PMID: 25575640 BACKGROUND

• 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.

  PMID: 35007812 BACKGROUND

MeSH Terms

Conditions

Nasopharyngeal Carcinoma; Stomatitis

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Mouth Diseases

Study Officials

• Min Kang, M.D

  Department of Radiation Oncology, The First Affiliated Hospital of Guangxi Medical University

  STUDY CHAIR

Central Study Contacts

Zhen Meng, M.D

CONTACT

86-771-5356509; mengzhen0307@163.com

Yating Qin, M.D

CONTACT

86-771-5356509; qyt201680138@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: June 7, 2023
• Study Start: June 12, 2023
• Primary Completion: April 30, 2025
• Study Completion (Estimated): April 1, 2027
• Last Updated: August 7, 2024

Record last verified: 2024-08

Locations

CN (20)