Clinical trial NCT05892354: Effect of Immunonutrients on Oral Mucositis in Nasopharyngeal Carcinoma Patients After Chemoradiotherapy
Official title: Efficacy of Immunonutrients in Reducing Oral Mucositis in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma: A Prospective, Multicenter, Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Locally Advanced Nasopharyngeal Carcinoma
Keywords: Immunonutrition
Nasopharyngeal Carcinoma
Chemoradiotherapy
Oral Mucositis
Lead sponsor: First Affiliated Hospital of Guangxi Medical University
Sponsor class: OTHER
Collaborators: name: Guangdong Provincial People's Hospital
name: Zhejiang Cancer Hospital
name: Zhejiang Provincial People's Hospital
name: Fujian Cancer Hospital
name: Fujian Provincial Hospital
name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: The First Affiliated Hospital of Nanchang University
name: Second Affiliated Hospital of Nanchang University
name: Affiliated Cancer Hospital & Institute of Guangzhou Medical University
name: Qingdao Central Hospital
name: Huizhou Municipal Central Hospital
name: Haikou People's Hospital
name: The Second Affiliated Hospital of Hainan Medical University
name: Zhejiang Provincial Tongde Hospital
name: Guilin Medical University, China
name: Liuzhou Workers Hospital
name: Wuzhou Red Cross Hospital
name: Red Cross Hospital of Yulin City
name: First People's Hospital of Yulin
name: Hainan Cancer Hospital
First posted: 2023-06-07
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

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.

Primary outcomes:
measure: The incidence of severe oral mucositis
timeFrame: 7 weeks
Secondary outcomes:
measure: The latency period of severe oral mucositis
timeFrame: 7 weeks
measure: The duration period of severe oral mucositis
timeFrame: 7 weeks
measure: Assessment of immune state
timeFrame: 4 months
measure: Serum hypersensitive C-reactive protein (hsCRP) level
timeFrame: 4 months
measure: Serum Interleukin-6 (IL-6) level
timeFrame: 4 months
measure: Hemoglobin level
timeFrame: 4 months
measure: Serum albumin level
timeFrame: 4 months
measure: Serum Pre-Albumin level
timeFrame: 4 months
measure: Nutritional risk
timeFrame: 4 months
measure: Nutrition status
timeFrame: 4 months
measure: Physical functional status
timeFrame: 4 months
measure: overall survival rate (OS)
timeFrame: at 2 years after randomisation
measure: progression-free survival rate (PFS)
timeFrame: at 2 years after randomisation
measure: Locoregional recurrence free survival rate (LRRFS)
timeFrame: at 2 years after randomisation
measure: Distance metastasis-free survival rate (DMFS)
timeFrame: at 2 years after randomisation
measure: Quality of life (QoL) assessed by EORTC QLQ-C30 questionnaire
timeFrame: 4 months
measure: Quality of life (QoL) assessed by the EORTC-QLQ-H&N35 Questionnaire
timeFrame: 4 months
measure: Number of participants with adverse events
timeFrame: up to 2 years after randomisation
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Provincial Hospital
state: Fujian
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
state: Fujian
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Affiliated Cancer Hospital & Institute of Guangzhou Medical University
state: Guangdong
city: Huizhou
country: China
facility: Huizhou Municipal Central Hospital
state: Guangdong
city: Nanning
country: China
facility: The First Affiliated Hospital of Guangxi Medical University
state: Guangxi Zhuang Autonomous Region
city: Guilin
country: China
facility: The Affiliated Hospital of Guilin Medical University
state: Guangxi
city: Liuzhou
country: China
facility: Liuzhou Workers Hospital
state: Guangxi
city: Wuzhou
country: China
facility: Wuzhou Red Cross Hospital
state: Guangxi
city: Yulin
country: China
facility: First People People's Hospital of Yulin City
state: Guangxi
city: Yulin
country: China
facility: Red Cross Hospital of Yulin City
state: Guangxi
city: Haikou
country: China
facility: Huizhou Municipal Central Hospital
state: Hainan
city: Haikou
country: China
facility: The Second Affiliated Hospital of Hainan Medical University
state: Hainan
city: Haikou
country: China
facility: Hainan Cancer Hospital
state: Hainan
city: Nanchang
country: China
facility: Second Affiliated Hospital of Nanchang University
state: Jiangxi
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Qingdao
country: China
facility: Qingdao Central Hospital
state: Shandong
city: Hangzhou
country: China
facility: Zhejiang Provincial Tongde Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Department of Radiation Oncology, The First Affiliated Hospital of Guangxi Medical University
name: Min Kang, M.D
role: STUDY_CHAIR
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