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

NCT05101889 | Completed Phase 2

• 1 other identifier: REC.56-036-13-1-1
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Oral Mucositis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

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

  through study completion, an average of 6 weeks

• body weight in kilograms

  6 weeks after initiation of CCRT and 1 month after CCRT completion

• serum albumin in grams per deciliter (g/dL)

  6 weeks after initiation of CCRT and 1 month after CCRT completion

• hemoglobin in grams per deciliter (g/dL)

  6 weeks after initiation of CCRT and 1 month after CCRT completion

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

  6 weeks after initiation of CCRT and 1 month after CCRT completion

Study Arms (2)

Immunonutrition

EXPERIMENTAL

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®

Control

ACTIVE COMPARATOR

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®

Interventions

Oral Impact® DIETARY_SUPPLEMENT

3 ready-to-drink bottles/day

Also known as: Blendera®

Control; Immunonutrition

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Prince of Songkla University: lead

Related Publications (1)

• 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.

  PMID: 35007812 DERIVED

MeSH Terms

Conditions

Stomatitis; Head and Neck Neoplasms; Nasopharyngeal Neoplasms

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Neoplasms by Site; Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: phase II randomized, double-blind study

Study Record Dates

• First Submitted: September 29, 2021
• First Posted: November 1, 2021
• Study Start: January 11, 2013
• Primary Completion: January 31, 2017
• Study Completion: January 31, 2017
• Last Updated: November 1, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share