Immunonutrition Supplementation in Head and Neck Cancer Patients Undergoing Cancer Treatment Study

NCT05526040 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2022-09-02

No results posted yet for this study

Summary

This is a prospective, randomized, open-label intervention study to evaluate the effectiveness of immunonutrition supplementation in head and neck cancer (HNC) patients during cancer treatment.

Conditions

Interventions

DIETARY_SUPPLEMENT

Immunonutrient-enriched oral nutrition supplementation

Individualized dietary assessment and counselling with additional high energy, high protein, immunonutrient-enriched oral nutrition supplement; taken 3 servings per day, from 1 week prior to cancer treatment and continued throughout the cancer treatment. Oral Impact® is an oral nutrition supplement product enriched with arginine (3.3g/sachet), omega-3 fatty acids (0.8g/sachet) and nucleotides (0.3g/sachet). The immunonutrient-enriched formula is also a complete and balanced formula, and is gluten free. The osmolality of the formula is 620 mOsm/kg water.

DIETARY_SUPPLEMENT

Standard medical nutrition therapy

Individualized dietary assessment and counselling and standard nutrition supplementation via oral nutrition supplementation or enteral nutrition as necessary.

Sponsors & Collaborators

  • University of Malaya

    lead OTHER

Principal Investigators

  • Hazreen Abdul Majid, Prof. Dr. · Department of Social and Preventive Medicine, Faculty of Medicine, University of Malaya

  • Sing Ean Tan · Department of Social and Preventive Medicine, Faculty of Medicine, University of Malaya

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-01
Primary Completion
2023-06-30
Completion
2023-12-31

Countries

  • Malaysia

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05526040 on ClinicalTrials.gov