Benefits of Immunonutrition in Patients With Head and Neck Cancer Receiving Chemoradiation

Study Overview
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Brief Summary
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This study evaluated the benefits of immunonutrition regarding the prevention of severe mucositis. Patients with head and neck cancer (HNC) undergoing definitive concurrent chemoradiation including 3-week cycles of cisplatin were enrolled in this double-blind phase II study. Patients were randomly assigned to receive an immunonutrition containing omega-3-fatty acids, arginine, dietary nucleotides, and soluble fiber or an isocaloric isonitrogenous control. All patients received the assigned product 5 days before each chemotherapy session. The proportion of patients with severe mucositis was compared between the immunonutrition and control groups.

Official Title
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Benefits of Immunonutrition in Patients With Head and Neck Cancer Receiving Chemoradiation: A Phase II Randomized, Double-blind Study

Conditions
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Oral Mucositis

Intervention / Treatment
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* Dietary Supplement: Oral Impact®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age of 18-65 years histological confirmation of stage II-IVb non-metastatic HNC according to the seventh edition of the American Joint Committee on Cancer Staging System (AJCC 2010) receipt of definitive CCRT Eastern Cooperative Oncology Group performance status of 0-1 creatinine clearance ≥ 60 mL/min/1.73 m2 calculated by the Cockcroft-Gault formula absence of mucositis able to tolerate oral feeding Exclusion Criteria: receipt of curative surgery for HNC allergies to any component of the immunonutrition

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: phase II randomized, double-blind study
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immunonutrition<br>Oral immunomodulating formula (Oral Impact®, Nestle) One sachet of Oral Impact® consisted of 74 g of powder providing 303 kilocalories. Three ready-to-drink bottles contained 303 kilocalories/bottle per day, starting 5 days before each chemotherapy session. | Dietary Supplement: Oral Impact®<br>* 3 ready-to-drink bottles/day<br>* Other names: Blendera®;|
| Active Comparator: Control<br>An isocaloric isonitrogenous standard enteral nutrition formula. Three ready-to-drink bottles contained 303 kilocalories/bottle per day, starting 5 days before each chemotherapy session. | Dietary Supplement: Oral Impact®<br>* 3 ready-to-drink bottles/day<br>* Other names: Blendera®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severe oral mucositis graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 criteria | Proportion of severe oral mucositis between two groups | 6 weeks after initiation of concurrent chemoradiation (CCRT) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other treatment-related toxicities graded according to the NCI CTCAE version 4.03 criteria | Proportion of patients with other treatment-related toxicities between two groups | through study completion, an average of 6 weeks | 
| body weight in kilograms | mean changes of body weight between two groups | 6 weeks after initiation of CCRT and 1 month after CCRT completion | 
| serum albumin in grams per deciliter (g/dL) | mean serum albumin between two groups | 6 weeks after initiation of CCRT and 1 month after CCRT completion | 
| hemoglobin in grams per deciliter (g/dL) | mean hemoglobin between two groups | 6 weeks after initiation of CCRT and 1 month after CCRT completion | 
| C-reactive protein (CRP) in milligrams per liter (mg/L) | mean CRP between two groups | 6 weeks after initiation of CCRT and 1 month after CCRT completion | 
| neutrophil-to-lymphocyte ratio (NLR) | mean NLR between two groups | 6 weeks after initiation of CCRT and 1 month after CCRT completion | 
| platelet-to-lymphocyte ratio (PLR) | mean PLR between two groups | 6 weeks after initiation of CCRT and 1 month after CCRT completion | 
| actual dose of radiation in centigrays (cGy) | mean actual dose of radiation between two groups | through study completion, an average of 6 weeks | 
| cumulative dose of cisplatin in milligrams per square meter (mg/m2) | mean cumulative dose of cisplatin between two groups | through study completion, an average of 6 weeks | 
| progression-free survival (PFS) | compare PFS between two groups | at 3 years | 
| overall survival (OS) | compare OS between two groups | at 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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head and neck cancer, nasopharyngeal cancer, immunonutrition, concurrent chemoradiation, survival