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Locally Advanced Nasopharyngeal CarcinomaNCT05892354

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

A study testing Enteral immunonutrition and Standard enteral nutrition in people with Locally Advanced Nasopharyngeal Carcinoma, run by First Affiliated Hospital of Guangxi Medical University at 20 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Enteral immunonutrition and Standard enteral nutrition
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
190 participants
Where
20 sitesChina
Study dates
12 Jun 2023to 1 Apr 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 14Show fewer
  • 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.

Trial locations and contacts

20 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Zhen Meng, M.D contact

86-771-5356509

mengzhen0307@163.com

Yating Qin, M.D contact

86-771-5356509

qyt201680138@163.com

20 sites in 1 country

China20 sites, 20 recruiting

  • Fujian Provincial Hospital

    Fuzhou, Fujian, 350000

    Jingbo Chen, MD, +86 591 8821 8888, 13635294192@163.com

    Recruiting

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350014

    Yun Xu, MD, 308466040@qq.com

    Recruiting

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong, 510060

    Dehuan Xie, MD, +86 20 8382 7812, xiedehuan@gdph.org.cn

    Recruiting

  • Affiliated Cancer Hospital & Institute of Guangzhou Medical University

    Guangzhou, Guangdong, 510070

    Mingyi Li, MD, +86 20 8359 5032

    Recruiting

  • The Affiliated Hospital of Guilin Medical University

    Guilin, Guangxi, 541001

    Meilian Liu, +86 773 283 3086

    Recruiting

  • Huizhou Municipal Central Hospital

    Haikou, Hainan, 570208

    Feng Yuan, MD, +86 898 6615 1001

    Recruiting

  • The Second Affiliated Hospital of Hainan Medical University

    Haikou, Hainan, 570311

    Junnv Xu, MD, +86 898 6680 9130

    Recruiting

  • Hainan Cancer Hospital

    Haikou, Hainan, 570314

    Pingting Zhou, MD, +86 898 6855 2139, 18689525165@163.com

    Recruiting

  • Zhejiang Provincial Tongde Hospital

    Hangzhou, Zhejiang, 310012

    Zhongzhu Tang, MD, +86 571 8992 0000

    Recruiting

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang, 310014

    limin Luo, MD, 21259400@qq.com

    Recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

    Yonghong Hua, MD, +86 571 8812 8218, nc.gro.ccjz@yquh.com

    Recruiting

  • Huizhou Municipal Central Hospital

    Huizhou, Guangdong, 516001

    Ying Shao, MD, +86 752 217 8126, shaoying8718@163.com

    Recruiting

  • Liuzhou Workers Hospital

    Liuzhou, Guangxi, 545025

    Zhuohua Xu, MS

    Recruiting

  • Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330000

    Jianwu Ding, MD, +86 791 8629 7662

    Recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330209

    Shaoqing Chen, MD, 7687105701@qq.com

    Recruiting

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi, 530000

    Zhen Meng, M.D, 07715356509, mengzhen0307@163.com

    Yating Qin, M.D, 07715356509, 937125122@qq.com

    Recruiting

  • Qingdao Central Hospital

    Qingdao, Shandong, 266044

    Xiaotao Zhang, MD

    Recruiting

  • Wuzhou Red Cross Hospital

    Wuzhou, Guangxi, 543002

    Lingling Fan, MS, +86 774 382 3120

    Recruiting

  • First People People's Hospital of Yulin City

    Yulin, Guangxi, 537001

    Leifeng Liang, MD

    Recruiting

  • Red Cross Hospital of Yulin City

    Yulin, Guangxi, 537006

    Shuang Li, MS, +86 774 382 3120

    Recruiting

Other trials in China

About this study

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

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.

Read the 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.

Being tested
Enteral immunonutrition, Standard enteral nutrition
Keywords
Immunonutrition, Nasopharyngeal Carcinoma, Chemoradiotherapy, Oral Mucositis
Medical subject headings
Nasopharyngeal Carcinoma, Stomatitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Enteral immunonutritionDietary supplement

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

  • Standard enteral nutritionDietary 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).

Study groups in NCT05892354
Study groupRoleWhat they receive
Immunonutrition GroupExperimentalInduction 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.
Receives: Dietary Supplement: Enteral immunonutrition
Control GroupActive comparatorInduction 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).
Receives: Dietary Supplement: Standard enteral nutrition

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The incidence of severe oral mucositis

    Incidence of grade 3-4 oral mucositis

    Measured: 7 weeks

Secondary outcomes (18)

  1. The latency period of severe oral mucositis

    Total duration from the start of radiotherapy to the severe oral mucositis

    Measured: 7 weeks

  2. The duration period of severe oral mucositis

    The number of days of severe oral mucositis during the oral mucositis observation period

    Measured: 7 weeks

  3. Assessment of immune state

    T-lymphocyte subsets

    Measured: 4 months

  4. Serum hypersensitive C-reactive protein (hsCRP) level

    Change in high sensitivity C-reactive protein from baseline to end of radiotherapy

    Measured: 4 months

  5. Serum Interleukin-6 (IL-6) level

    Change in serum level of Interleukin-6 from baseline to end of radiotherapy

    Measured: 4 months

  6. Hemoglobin level

    Change in hemoglobin level from baseline to end of radiotherapy

    Measured: 4 months

  7. Serum albumin level

    Change in hemoglobin level from baseline to end of radiotherapy

    Measured: 4 months

  8. Serum Pre-Albumin level

    Change in hemoglobin level from baseline to end of radiotherapy

    Measured: 4 months

  9. Nutritional risk

    Change in nutritional risk determined by the by the nutrition risk screening-2002 (NRS-2002) from baseline to end of radiotherapy

    Measured: 4 months

  10. Nutrition status

    Change in nutritional status determined by the Patient-Generated Subjective Global Assessment (PG-SGA) from baseline to end of radiotherapy

    Measured: 4 months

  11. Physical functional status

    Changes in handgrip strength from baseline to end of radiotherapy

    Measured: 4 months

  12. overall survival rate (OS)

    compare OS between two groups

    Measured: at 2 years after randomisation

  13. progression-free survival rate (PFS)

    compare PFS between two groups

    Measured: at 2 years after randomisation

  14. Locoregional recurrence free survival rate (LRRFS)

    compare LRRFS between two groups

    Measured: at 2 years after randomisation

  15. Distance metastasis-free survival rate (DMFS)

    compare DMFS between two groups

    Measured: at 2 years after randomisation

  16. Quality of life (QoL) assessed by EORTC QLQ-C30 questionnaire

    EORTC QLQ-C30 is a specific quality of life assessment scale based on EORTC QLQ-C 30, with 35 items. All of the scales and single-item measures range from 0 to 100. A EORTC QLQ-C30 is a specific quality of life assessment scale, with 30 items. All of the scales and single-item measures range from 0 to 100. More global and functional scales is better. less symptom scales is better.

    Measured: 4 months

  17. Quality of life (QoL) assessed by the EORTC-QLQ-H&N35 Questionnaire

    EORTC QLQ-H\&N35 is a specific quality of life assessment scale based on EORTC QLQ-C 30, with 35 items. All of the scales and single-item measures range from 0 to 100. High scores represent increased (worse) symptoms.

    Measured: 4 months

  18. Number of participants with adverse events

    Analysis of acute and late adverse events (AEs) are evaluated.

    Measured: up to 2 years after randomisation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2023
  2. Study start12 Jun 2023
  3. Primary completion30 Apr 2025 (estimated)
  4. Study completion1 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
190 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05892354
Sponsor's protocol ID
FirstGuangxiMu3
Status last verified
Aug 2024
First submitted
24 Apr 2023
Last updated
7 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 27113797

  • 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.

    PubMed 34910297

  • 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.

    PubMed 33841399

  • 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.

    PubMed 27644137

  • 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.

    PubMed 33240818

  • 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.

    PubMed 29671062

  • 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.

    PubMed 33598427

  • 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.

    PubMed 32936874

  • 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.

    PubMed 25575640

  • 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.

    PubMed 35007812

Questions about this trial

What is this clinical trial studying?

A study testing Enteral immunonutrition and Standard enteral nutrition in people with Locally Advanced Nasopharyngeal Carcinoma, run by First Affiliated Hospital of Guangxi Medical University at 20 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Zhen Meng, M.D (86-771-5356509, mengzhen0307@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence of severe oral mucositis (time frame: 7 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05892354, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2024.

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