Immunonutrition Supplementation in Head and Neck Cancer Patients Undergoing Cancer Treatment Study (HaNIS)

Head and Neck Cancer Immunonutrition Supplementation During Cancer Treatment: A Randomized, Open-label Intervention Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Dietary supplement: Immunonutrient-enriched oral nutrition supplementation; Dietary supplement: Standard medical nutrition therapy

Detailed Description

The study population will be adult HNC patients receiving radiotherapy and chemotherapy treatment. The targeted number of subjects is 116 patients (58 subjects in each arm). Participants will be randomly assigned to receive standard medical nutrition therapy (individualized dietary assessment and counselling, and standard nutrition supplementation as necessary) or standard medical nutrition therapy with high energy, high protein, immunonutrient-enriched oral nutrition supplementation. Immunonutrition supplementation will begin 1 week prior to cancer treatment and continued throughout the cancer treatment, and to be taken in 3 servings/day. The study involves interviewing of subjects for dietary and nutrition assessment; measurement of weight, body composition, handgrip strength; and data collection from subjects' medical records.

• Study Type: Interventional
• Enrollment (Anticipated): 116
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hazreen Abdul Majid, Prof. Dr.; Phone Number: +603-79674757; Email: hazreen@ummc.edu.my
• Study Contact Backup: Name: Sing Ean Tan; Email: tansingean@gmail.com

Study Locations

• Malaysia
  • Wilayah Persekutuan Kuala Lumpur
    • Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia, 50586
      • Hospital Kuala Lumpur
      • Contact: Sing Ean Tan; Email: tansingean@gmail.com
      • Principal Investigator: Sing Ean Tan
      • Sub-Investigator: Ibtisam Muhamad Nor
    • Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia, 59100
      • University of Malaya Medical Centre
      • Contact: Hazreen Abdul Majid, Prof. Dr.; Phone Number: +603-7967 4757; Email: hazreen@ummc.edu.my
      • Principal Investigator: Hazreen Abdul Majid, Prof. Dr.
      • Sub-Investigator: Nur Fadhlina Abdul Satar, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Written informed consent obtained
• Adult HNC patients, male or female, above 18 years of age
• Primary HNC diagnosis, stage I to III; including: cancer of the nasopharynx, oropharynx, oral cavity, hypopharynx, or larynx, etc.
• Referred and planned for curative-intent cancer treatment (radiotherapy and chemotherapy)
• Eastern Cooperative Oncology Group (ECOG) performance status < 2

Exclusion Criteria:

• Inability or unwillingness to provide written informed consent or comply with the requirements of the protocol
• Patients with metastatic stage or recurring/relapse of cancer at same site
• Planned for palliative cancer treatment
• Underlying severe hepatic failure or renal dysfunction (eGFR < 30ml/min/1.73m2)
• Underlying severe sepsis, neutropenia, immune-deficiencies or autoimmune diseases
• Consumption of supplements or enriched foods containing immunonutrients (omega- 3, arginine or nucleotides) in the previous month prior to study; including dietary supplements such as: fish oil capsules, arginine tablets/powder, RNA capsules, etc.
• Known allergy or intolerance to components of the immunonutrition supplement (cow's milk, fish or soy)
• Enrolment in other cancer treatment trials

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention; Standard medical nutrition therapy with Immunonutrition	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.; Other Names: Oral Impact®, Nestle
ACTIVE_COMPARATOR: Control; Standard medical nutrition therapy	Dietary supplement: Standard medical nutrition therapy; Individualized dietary assessment and counselling and standard nutrition supplementation via oral nutrition supplementation or enteral nutrition as necessary.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body weight (kilograms)	Changes in body weight during study period	Baseline, weekly review during cancer treatment, 1month post-completion of cancer treatment
Nutrition status - scored Patient-Generated Subjective Global Assessment (PG-SGA)	Changes in nutrition status during study period (3 categories: A- well nourished, B- moderately or suspected of being malnourished, and C- severely malnourished)	Baseline, initiation of cancer treatment, completion of cancer treatment, 1month post-completion of cancer treatment
Nutrition status - 3-Minute Nutrition Screening (3-minNS) tool	Changes in nutrition status during study period (score of 3 to 4 indicates risk of moderate malnutrition, and score of 5 to 9 indicates risk of severe malnutrition)	Baseline, initiation of cancer treatment, completion of cancer treatment, 1month post-completion of cancer treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Handgrip strength	Changes in handgrip strength during study period	Baseline, initiation of cancer treatment, completion of cancer treatment, 1month post-completion of cancer treatment
Functional status - Eastern Cooperative Oncology Group (ECOG) Performance Status Score	Changes in functional status during study period (score of 0 to 4; whereby 0- fully active and able to carry out all activities without any restrictions, and 4- completely disabled, unable to carry on any selfcare and confined to bed or chair)	Baseline, initiation of cancer treatment, completion of cancer treatment, 1month post-completion of cancer treatment

Collaborators and Investigators

• Sponsor: University of Malaya
• Investigators: Principal Investigator: Hazreen Abdul Majid, Prof. Dr., Department of Social and Preventive Medicine, Faculty of Medicine, University of Malaya; Principal Investigator: Sing Ean Tan, Department of Social and Preventive Medicine, Faculty of Medicine, University of Malaya

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): November 1, 2022
• Primary Completion (ANTICIPATED): June 30, 2023
• Study Completion (ANTICIPATED): December 31, 2023

Study Registration Dates

• First Submitted: August 30, 2022
• First Submitted That Met QC Criteria: September 1, 2022
• First Posted (ACTUAL): September 2, 2022

Study Record Updates

• Last Update Posted (ACTUAL): September 2, 2022
• Last Update Submitted That Met QC Criteria: September 1, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: radiotherapy; head and neck cancer; immunonutrition; arginine; cancer treatment; omega 3 fatty acid
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: HaNIS-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No