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

Sponsor

Prince of Songkla University (Other)

Overall Status

Completed

CT.gov ID

NCT05101889

Collaborator

(none)

110

Enrollment

Arms

48.7

Actual Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Oral Mucositis	Dietary Supplement: Oral Impact®	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

110 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

phase II randomized, double-blind studyphase II randomized, double-blind study

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jan 11, 2013

Actual Primary Completion Date :

Jan 31, 2017

Actual Study Completion Date :

Jan 31, 2017

Arms and Interventions

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®

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®

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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