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

Primary Purpose

Head and Neck Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Immunonutrient-enriched oral nutrition supplementation
Standard medical nutrition therapy
Sponsored by
University of Malaya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Head and Neck Cancer focused on measuring immunonutrition, arginine, omega 3 fatty acid, radiotherapy, cancer treatment, head and neck cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Kuala Lumpur
  • University of Malaya Medical Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Control

Arm Description

Standard medical nutrition therapy with Immunonutrition

Standard medical nutrition therapy

Outcomes

Primary Outcome Measures

Body weight (kilograms)
Changes in body weight during study period
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)
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)

Secondary Outcome Measures

Handgrip strength
Changes in handgrip strength during study period
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)

Full Information

First Posted
August 30, 2022
Last Updated
September 1, 2022
Sponsor
University of Malaya
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1. Study Identification

Unique Protocol Identification Number
NCT05526040
Brief Title
Immunonutrition Supplementation in Head and Neck Cancer Patients Undergoing Cancer Treatment Study
Acronym
HaNIS
Official Title
Head and Neck Cancer Immunonutrition Supplementation During Cancer Treatment: A Randomized, Open-label Intervention Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2022 (Anticipated)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Malaya

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
immunonutrition, arginine, omega 3 fatty acid, radiotherapy, cancer treatment, head and neck cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
116 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Standard medical nutrition therapy with Immunonutrition
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Standard medical nutrition therapy
Intervention Type
Dietary Supplement
Intervention Name(s)
Immunonutrient-enriched oral nutrition supplementation
Other Intervention Name(s)
Oral Impact®, Nestle
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Standard medical nutrition therapy
Intervention Description
Individualized dietary assessment and counselling and standard nutrition supplementation via oral nutrition supplementation or enteral nutrition as necessary.
Primary Outcome Measure Information:
Title
Body weight (kilograms)
Description
Changes in body weight during study period
Time Frame
Baseline, weekly review during cancer treatment, 1month post-completion of cancer treatment
Title
Nutrition status - scored Patient-Generated Subjective Global Assessment (PG-SGA)
Description
Changes in nutrition status during study period (3 categories: A- well nourished, B- moderately or suspected of being malnourished, and C- severely malnourished)
Time Frame
Baseline, initiation of cancer treatment, completion of cancer treatment, 1month post-completion of cancer treatment
Title
Nutrition status - 3-Minute Nutrition Screening (3-minNS) tool
Description
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)
Time Frame
Baseline, initiation of cancer treatment, completion of cancer treatment, 1month post-completion of cancer treatment
Secondary Outcome Measure Information:
Title
Handgrip strength
Description
Changes in handgrip strength during study period
Time Frame
Baseline, initiation of cancer treatment, completion of cancer treatment, 1month post-completion of cancer treatment
Title
Functional status - Eastern Cooperative Oncology Group (ECOG) Performance Status Score
Description
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)
Time Frame
Baseline, initiation of cancer treatment, completion of cancer treatment, 1month post-completion of cancer treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hazreen Abdul Majid, Prof. Dr.
Phone
+603-79674757
Email
hazreen@ummc.edu.my
First Name & Middle Initial & Last Name or Official Title & Degree
Sing Ean Tan
Email
tansingean@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hazreen Abdul Majid, Prof. Dr.
Organizational Affiliation
Department of Social and Preventive Medicine, Faculty of Medicine, University of Malaya
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sing Ean Tan
Organizational Affiliation
Department of Social and Preventive Medicine, Faculty of Medicine, University of Malaya
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Kuala Lumpur
City
Kuala Lumpur
State/Province
Wilayah Persekutuan Kuala Lumpur
ZIP/Postal Code
50586
Country
Malaysia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sing Ean Tan
Email
tansingean@gmail.com
First Name & Middle Initial & Last Name & Degree
Sing Ean Tan
First Name & Middle Initial & Last Name & Degree
Ibtisam Muhamad Nor
Facility Name
University of Malaya Medical Centre
City
Kuala Lumpur
State/Province
Wilayah Persekutuan Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hazreen Abdul Majid, Prof. Dr.
Phone
+603-7967 4757
Email
hazreen@ummc.edu.my
First Name & Middle Initial & Last Name & Degree
Hazreen Abdul Majid, Prof. Dr.
First Name & Middle Initial & Last Name & Degree
Nur Fadhlina Abdul Satar, Dr.

12. IPD Sharing Statement

Plan to Share IPD
No

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

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