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

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

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 Overview

• Status: Completed
• Conditions: Oral Mucositis
• Intervention / Treatment: Dietary supplement: Oral Impact®

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immunonutrition; 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®; 3 ready-to-drink bottles/day; Other Names: Blendera®
Active Comparator: Control; 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®; 3 ready-to-drink bottles/day; Other Names: Blendera®

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Prince of Songkla University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2013
• Primary Completion (Actual): January 31, 2017
• Study Completion (Actual): January 31, 2017

Study Registration Dates

• First Submitted: September 29, 2021
• First Submitted That Met QC Criteria: October 21, 2021
• First Posted (Actual): November 1, 2021

Study Record Updates

• Last Update Posted (Actual): November 1, 2021
• Last Update Submitted That Met QC Criteria: October 21, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: survival; head and neck cancer; immunonutrition; nasopharyngeal cancer; concurrent chemoradiation
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Diseases; Gastroenteritis; Stomatognathic Diseases; Mouth Diseases; Head and Neck Neoplasms; Mucositis; Stomatitis
• Other Study ID Numbers: REC.56-036-13-1-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No