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

NCT ID: NCT05101889

Last Updated: 2021-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-11

Study Completion Date

2017-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Oral Mucositis

Keywords

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head and neck cancer nasopharyngeal cancer immunonutrition concurrent chemoradiation survival

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

phase II randomized, double-blind study
Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Oral Impact®

Intervention Type DIETARY_SUPPLEMENT

3 ready-to-drink bottles/day

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.

Group Type ACTIVE_COMPARATOR

Oral Impact®

Intervention Type DIETARY_SUPPLEMENT

3 ready-to-drink bottles/day

Interventions

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Oral Impact®

3 ready-to-drink bottles/day

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Blendera®

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Prince of Songkla University

OTHER

Sponsor Role lead

Responsible Party

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Arunee Dechaphunkul

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type DERIVED
PMID: 35007812 (View on PubMed)

Other Identifiers

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REC.56-036-13-1-1

Identifier Type: -

Identifier Source: org_study_id