Back to results

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

Primary Purpose

Oral Mucositis

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Oral Impact®

About this trial

This is an interventional prevention trial for Oral Mucositis focused on measuring head and neck cancer, nasopharyngeal cancer, immunonutrition, concurrent chemoradiation, survival

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Exclusion Criteria:

receipt of curative surgery for HNC
allergies to any component of the immunonutrition

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Immunonutrition

Control

Arm Description

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.

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.

Outcomes

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

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

Proportion of patients with other treatment-related toxicities between two groups

body weight in kilograms

mean changes of body weight between two groups

serum albumin in grams per deciliter (g/dL)

mean serum albumin between two groups

hemoglobin in grams per deciliter (g/dL)

mean hemoglobin between two groups

C-reactive protein (CRP) in milligrams per liter (mg/L)

mean CRP between two groups

neutrophil-to-lymphocyte ratio (NLR)

mean NLR between two groups

platelet-to-lymphocyte ratio (PLR)

mean PLR between two groups

actual dose of radiation in centigrays (cGy)

mean actual dose of radiation between two groups

cumulative dose of cisplatin in milligrams per square meter (mg/m2)

mean cumulative dose of cisplatin between two groups

progression-free survival (PFS)

compare PFS between two groups

overall survival (OS)

compare OS between two groups

Full Information

NCT ID

NCT05101889

First Posted

September 29, 2021

Last Updated

October 21, 2021

Sponsor

Prince of Songkla University

1. Study Identification

Unique Protocol Identification Number

NCT05101889

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Completed

Study Start Date

January 11, 2013 (Actual)

Primary Completion Date

January 31, 2017 (Actual)

Study Completion Date

January 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Prince of Songkla University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Oral Mucositis

Keywords

head and neck cancer, nasopharyngeal cancer, immunonutrition, concurrent chemoradiation, survival

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

phase II randomized, double-blind study

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

110 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Immunonutrition

Arm Type

Experimental

Arm Description

Arm Title

Control

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Dietary Supplement

Intervention Name(s)

Oral Impact®

Other Intervention Name(s)

Blendera®

Intervention Description

3 ready-to-drink bottles/day

Primary Outcome Measure Information:

Title

Severe oral mucositis graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 criteria

Description

Proportion of severe oral mucositis between two groups

Time Frame

6 weeks after initiation of concurrent chemoradiation (CCRT)

Secondary Outcome Measure Information:

Title

Other treatment-related toxicities graded according to the NCI CTCAE version 4.03 criteria

Description

Proportion of patients with other treatment-related toxicities between two groups

Time Frame

through study completion, an average of 6 weeks

Title

body weight in kilograms

Description

mean changes of body weight between two groups

Time Frame