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

Prince of Songkla University110 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

110

Conditions

Oral Mucositis

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 6 weeks after initiation of concurrent chemoradiation (CCRT)

Secondary Outcomes

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

Time frame: through study completion, an average of 6 weeks

body weight in kilograms

mean changes of body weight between two groups