Immunonutrition Supplementation in Head and Neck Cancer Patients Undergoing Cancer Treatment Study
NCT ID: NCT05526040
Last Updated: 2022-09-02
Study Results
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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UNKNOWN
NA
116 participants
INTERVENTIONAL
2022-11-01
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Intervention
Standard medical nutrition therapy with Immunonutrition
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.
Control
Standard medical nutrition therapy
Standard medical nutrition therapy
Individualized dietary assessment and counselling and standard nutrition supplementation via oral nutrition supplementation or enteral nutrition as necessary.
Interventions
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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.
Standard medical nutrition therapy
Individualized dietary assessment and counselling and standard nutrition supplementation via oral nutrition supplementation or enteral nutrition as necessary.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University of Malaya
OTHER
Responsible Party
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Principal Investigators
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Hazreen Abdul Majid, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Department of Social and Preventive Medicine, Faculty of Medicine, University of Malaya
Sing Ean Tan
Role: PRINCIPAL_INVESTIGATOR
Department of Social and Preventive Medicine, Faculty of Medicine, University of Malaya
Locations
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Hospital Kuala Lumpur
Kuala Lumpur, Kuala Lumpur, Malaysia
University of Malaya Medical Centre
Kuala Lumpur, Kuala Lumpur, Malaysia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HaNIS-1
Identifier Type: -
Identifier Source: org_study_id
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