Head and Neck CancerHaNISNCT05526040
Immunonutrition Supplementation in Head and Neck Cancer Patients Undergoing Cancer Treatment Study
A study testing Immunonutrient-enriched oral nutrition supplementation and Standard medical nutrition therapy in people with Head and Neck Cancer, run by University of Malaya at 2 sites in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Immunonutrient-enriched oral nutrition supplementation and Standard medical nutrition therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 2 sitesMalaysia
- Study dates
- 1 Nov 2022to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Sing Ean Tan contact
Malaysia2 sites
Hospital Kuala Lumpur
Kuala Lumpur, Kuala Lumpur, 50586
Sing Ean Tan, tansingean@gmail.com
Sing Ean Tan
University of Malaya Medical Centre
Kuala Lumpur, Kuala Lumpur, 59100
Hazreen Abdul Majid, Prof. Dr., +603-7967 4757, hazreen@ummc.edu.my
Hazreen Abdul Majid, Prof. Dr.
About this study
Official title: 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.
Read the 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.
- Conditions
- Head and Neck Cancer
- Being tested
- Immunonutrient-enriched oral nutrition supplementation, Standard medical nutrition therapy
- Keywords
- immunonutrition, arginine, omega 3 fatty acid, radiotherapy, cancer treatment, head and neck cancer
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunonutrient-enriched oral nutrition supplementationDietary supplement
Also called Oral Impact®, Nestle
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 therapyDietary supplement
Individualized dietary assessment and counselling and standard nutrition supplementation via oral nutrition supplementation or enteral nutrition as necessary.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Standard medical nutrition therapy with Immunonutrition Receives: Dietary Supplement: Immunonutrient-enriched oral nutrition supplementation |
| Control | Active comparator | Standard medical nutrition therapy Receives: Dietary Supplement: Standard medical nutrition therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight (kilograms)
Changes in body weight during study period
Measured: 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)
Measured: 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)
Measured: Baseline, initiation of cancer treatment, completion of cancer treatment, 1month post-completion of cancer treatment
Secondary outcomes (2)
Handgrip strength
Changes in handgrip strength during study period
Measured: 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)
Measured: Baseline, initiation of cancer treatment, completion of cancer treatment, 1month post-completion of cancer treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start1 Nov 2022 (estimated)
- Primary completion30 Jun 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hazreen Abdul Majid, Prof. Dr., Principal investigator, Department of Social and Preventive Medicine, Faculty of Medicine, University of MalayaSing Ean Tan, Principal investigator, Department of Social and Preventive Medicine, Faculty of Medicine, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05526040
- Sponsor's protocol ID
- HaNIS-1
- Acronym
- HaNIS
- Status last verified
- Sep 2022
- First submitted
- 30 Aug 2022
- Last updated
- 2 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Head and Neck Cancer Immunonutrition Supplementation During Cancer Treatment: A Randomized, Open-label Intervention Study
- ClinicalTrials.gov ID
- NCT05526040
- Acronym / sponsor ID
- HaNIS / HaNIS-1
- Conditions
- Head and Neck Cancer
- Keywords
- immunonutrition, arginine, omega 3 fatty acid, radiotherapy, cancer treatment, head and neck cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 1 Nov 2022 (estimated)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 2 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Dietary Supplement: Immunonutrient-enriched oral nutrition supplementationStandard medical nutrition therapy with Immunonutrition |
| Control | Active comparator | Dietary Supplement: Standard medical nutrition therapyStandard medical nutrition therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immunonutrient-enriched oral nutrition supplementationAlso: Oral Impact®, NestleIndividualized 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 | Intervention |
| Standard medical nutrition therapyIndividualized dietary assessment and counselling and standard nutrition supplementation via oral nutrition supplementation or enteral nutrition as necessary. | Dietary supplement | Control |
Primary outcome
Body weight (kilograms)
Time frame: Baseline, weekly review during cancer treatment, 1month post-completion of cancer treatment
Changes in body weight during study period
Nutrition status - scored Patient-Generated Subjective Global Assessment (PG-SGA)
Time frame: Baseline, initiation of cancer treatment, completion of cancer treatment, 1month post-completion of cancer treatment
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
Time frame: Baseline, initiation of cancer treatment, completion of cancer treatment, 1month post-completion of cancer treatment
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)
2 secondary outcomes
Handgrip strength
Time frame: 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
Time frame: Baseline, initiation of cancer treatment, completion of cancer treatment, 1month post-completion of cancer treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sing Ean Tan contact
Hazreen Abdul Majid, Prof. Dr. principal investigator
Department of Social and Preventive Medicine, Faculty of Medicine, University of Malaya
Sing Ean Tan principal investigator
Department of Social and Preventive Medicine, Faculty of Medicine, University of Malaya
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immunonutrient-enriched oral nutrition supplementation and Standard medical nutrition therapy in people with Head and Neck Cancer, run by University of Malaya at 2 sites in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hazreen Abdul Majid, Prof. Dr. (+603-79674757, hazreen@ummc.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight (kilograms) (time frame: Baseline, weekly review during cancer treatment, 1month post-completion of cancer treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2022.