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
1 other identifier
interventional
116
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable head-and-neck-cancer
Started Nov 2022
Shorter than P25 for not_applicable head-and-neck-cancer
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 30, 2022
CompletedFirst Posted
Study publicly available on registry
September 2, 2022
CompletedStudy Start
First participant enrolled
November 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedSeptember 2, 2022
September 1, 2022
8 months
August 30, 2022
September 1, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (2)
Handgrip strength
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
Baseline, initiation of cancer treatment, completion of cancer treatment, 1month post-completion of cancer treatment
Study Arms (2)
Intervention
EXPERIMENTALStandard medical nutrition therapy with Immunonutrition
Control
ACTIVE COMPARATORStandard medical nutrition therapy
Interventions
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.
Individualized dietary assessment and counselling and standard nutrition supplementation via oral nutrition supplementation or enteral nutrition as necessary.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Hospital Kuala Lumpur
Kuala Lumpur, Kuala Lumpur, 50586, Malaysia
University of Malaya Medical Centre
Kuala Lumpur, Kuala Lumpur, 59100, Malaysia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 30, 2022
First Posted
September 2, 2022
Study Start
November 1, 2022
Primary Completion
June 30, 2023
Study Completion
December 31, 2023
Last Updated
September 2, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share