MalnourishmentPhase 2NCT05379712
Nutritional Supplementation in Head and Neck Cancers
A Phase 2 study testing Resource® Support Plus in people with Malnourishment and Nutritional Deficiency, run by AHS Cancer Control Alberta at 1 site in Canada.
Trial summary
The purpose of this study is to determine whether multimodal nutrition therapy (primary nutrition intervention + adjuvant nutrition therapy) will support patients to optimize their total caloric intake during cancer treatment by measuring the difference in mean cumulative energy intake between the intervention and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malnourishment, Nutritional Deficiency, Undernutrition
- What is being tested?
- Resource® Support Plus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteCanada
- Study dates
- 25 Oct 2024to Oct 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Patients must have the ability to read, understand, and sign an informed consent and must be willing to comply with study treatment and follow-up.
- Male or female
- ≥18 years of age
- Histopathologically confirmed primary squamous cell carcinoma of the oral cavity and oropharynx, larynx or hypopharynx, who have agreed to receive radical intent radiotherapy as primary treatment or adjuvant treatment post-surgery, with or without platinum chemotherapy
- Capable of volitional oral nutritional intake at baseline.
- A diagnostic CT image taken with a maximum of 30 days before initiation of radical intent radiotherapy. If the CT scan history in the patient's clinical record does not include a study within this window, a baseline non-contrast enhanced CT abdomen will be conducted.
- An Eastern Cooperative Oncology Group Performance Status of ≤ 2
Who cannot join
- Fed by nasogastric tube, gastrostomy or total parenteral nutrition
- Cancer of the nasopharynx, thyroid or salivary gland
- Life expectancy <6 months.
- A known hypersensitivity / allergy to the investigational product or to any ingredient in their formulations (e.g. Milk/Lactose, Fish).
- Enrolment in any other clinical protocol or investigational study with an interventional agent or assessments that may interfere with study procedures.
- Patients with untreated brain metastases (patients with previously resected and/or radiated brain metastases without neurologic symptoms are permitted).
- Poorly controlled chronic illnesses or other inflammatory diseases (e.g. COPD, uncontrolled non-insulin dependent diabetes, rheumatoid arthritis).
- In the investigators' opinion, patients who have medical conditions that could interfere with nutrient metabolism or absorption (e.g., short bowel syndrome, Crohn's disease, etc.)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Vickie Baracos, 7804328232, Vickie.Baracos@albertahealthservices.ca
About this study
Official title: A Randomized Open Label Trial of Multimodal Oral Nutritional Supplementation Versus Standard Care, to Prevent / Attenuate Malnutrition in Patients with Cancers of the Head and Neck Receiving (chemo)-radiotherapy Treatment.
The purpose of this study is to determine whether multimodal nutrition therapy (primary nutrition intervention + adjuvant nutrition therapy) will support patients to optimize their total caloric intake during cancer treatment by measuring the difference in mean cumulative energy intake between the intervention and control group over the duration of cancer treatment.
Read the detailed description
This will be an randomized, open label, parallel assignment study during cancer treatment (Baseline - Week 7 for Primary endpoint) comparing multimodal oral nutrition therapy versus standard care. Starting at Week 8, all patients receive the intervention arm until study ends at Week 14. Patients in the intervention arm continue the intervention, patients on the standard care arm cross over to the intervention (deferred nutrition intervention).
The primary objective is to assess a multimodal nutrition therapy with two Medical Foods (primary nutrition intervention+ adjuvant nutrition therapy) with features adapted for patients with cancers of the head and neck receiving chemo-radiotherapy treatment, to maintain oral dietary intake during treatment.
- Conditions
- Malnourishment, Nutritional Deficiency, Undernutrition
- Being tested
- Resource® Support Plus
- Keywords
- Nutritional Support, Oral Nutritional Supplements
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resource® Support PlusOther
Nestlé Resource Support Plus® is a high energy- and protein-density Medical Food enriched with omega 3 polyunsaturated fatty acids. This is a nutritionally complete formula, in an easy to swallow, palatable, concentrated low volume, available in 2 flavours optimized for cancer patients undergoing chemotherapy and/or radiation in taste tests. It provides in a 125 mL serving: 250 kcal, 11.5 g protein and 0.95g of omega-3 fatty acid (eicosapentaenoic acid, EPA).
| Study group | Role | What they receive |
|---|---|---|
| Multimodal Nutrition Therapy | Experimental | To assess a multimodal nutrition therapy (primary nutrition intervention+ adjuvant nutrition therapy) with features adapted for patients with cancers of the head and neck receiving chemo-radiotherapy treatment, to maintain oral dietary intake during treatment. The regimen consists of 2 medical foods, each taken on an unrestricted basis (as and when preferred by each patient).
Resource® Support Plus, a nutritionally complete Medical Food specifically for the dietary management of oncology patients with (risk of) malnutrition.
BOOST® Soothe, a Medical Food formulated as a clear oral nutritional supplement for cancer patients with sensory alterations or oral discomfort due to cancer treatments, in particular chemo- and/or radiotherapy. Receives: Other: Resource® Support Plus |
| Standard of Care | No intervention | In this setting patients rely on oral dietary intake. Ordinary, commercially available ingredients and food products are consumed. The standard of care includes weekly consultation with specialist oncology Registered Dietitian. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean cumulative energy intake
Energy intake is calculated from a one-day diet record in which the patient lists the identity and quantity of all foods and beverages consumed in the designated 24 hour time period at the end of each week (Baseline - Week 14).
Measured: Up to 14 weeks
Secondary outcomes (13)
Change in mean cumulative protein take
Energy intake is calculated from a one-day diet record in which the patient lists the identity and quantity of all foods and beverages consumed in the designated 24 hour time period at the end of each week (Baseline - Week 14)
Measured: Up to 14 Weeks
Change in body weight (kg)
Change in weight (kg) from the previous week.
Measured: Baseline-Week 14
Change in Nutritional blood biomarkers
A sample of blood will be collected for albumin, absolute neutrophil count, lymphocyte count, C-reactive protein, standard complete blood count-differential White Blood cell count and to measure serum CRP and albumin
Measured: Baseline measures will be compared to levels at weeks 7 and 14
Head and Neck Symptom Checklist
A survey tool for HNC patient self-assessment of the presence and degree of interference with eating, over the past 3 days, of 17 symptoms known to impact dietary intake. Scores range from 34 to 170 pts, where higher scores reflect a greater presence and interference with eating. Completed at weeks 0, 4, 7, 11, 14
Measured: Up to 14 weeks
Taste and smell survey
A survey tool for patient self-assessment of the presence, characterization and severity of taste and smell alterations. This tool yields a 'chemosensory complaint score' of up to 16 (greatest severity of taste and smell alterations). Completed at weeks 0, 4, 7, 11, 14.
Measured: Up to 14 weeks
Medication use for pain
Use of pain medication will be captured weekly by a one- day pain medication log.
Measured: Up to 14 weeks
Percent oral intake from oral nutritional supplements
The volume (mL) of study products consumed will be determined from the weekly one-day diet record.
Measured: Up to 14 weeks
Product Sensory Assessment questionnaire
A product evaluation form for the Medical Nutrition products will be used to evaluate product overall sensory assessment, including acceptance and perception of characteristic product attributes that influence overall sensory acceptance. Medical Nutrition sensory acceptance will be evaluated by "overall liking" on the 9-point hedonic scale (1= dislike extremely; 9 = like extremely). Completed at weeks 0, 2, 4, 6, 8, 10, 12, 14.
Measured: Up to 14 weeks
Functional Assessment of Anorexia-Cachexia Treatment (FAACT) 5 Question Anorexia/Cachexia subscale (AC/S)
The FAACT is a validated Quality of Life Scale to capture patient experience of cancer related cachexia - anorexia. Completed at weeks 0, 4, 7,11, 14
Measured: Up to 14 weeks
Cumulative energy intake (kcal/kg BW)
Energy intake is calculated from a one-day diet record in which the patient lists the identity and quantity of all foods and beverages consumed in the designated 24 hour time period at the end of each week (Baseline - Week 14)
Measured: Up to 14 weeks
Cumulative protein take (g pro/kg BW)
Protein intake is calculated from a one-day diet record in which the patient lists the identity and quantity of all foods and beverages consumed in the designated 24 hour time period at the end of each week (Baseline - Week 14)
Measured: Up to 14 weeks
Change in computed-tomography (CT) defined skeletal muscle and fat mass)
Imaging for body composition (muscle, fat)
Measured: Within 30 days prior to start of treatment, Week 14
Tertiary hospital admission
Review of patient medical records for instances of hospitalization with date(s) of admission falling between baseline and week 14 of study.
Measured: Up to 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start25 Oct 2024
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnourishmentStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized (multimodal oral nutrition therapy versus standard care), open label, parallel assignment, during cancer treatment (Baseline - Week 7 for Primary endpoint). Starting at Week 8, all patients receive the intervention arm until study ends at Week 14. Patients in the intervention arm continue the intervention, patients on the standard care arm cross over to the intervention (deferred nutrition intervention).
- Masking
- None (open label)
- Enrolment
- 81 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AHS Cancer Control Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vickie Baracos, Principal investigator, Cross Cancer Institute, Alberta Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05379712
- Sponsor's protocol ID
- IIT-0024
- Status last verified
- Oct 2024
- First submitted
- 13 May 2022
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Open Label Trial of Multimodal Oral Nutritional Supplementation Versus Standard Care, to Prevent / Attenuate Malnutrition in Patients with Cancers of the Head and Neck Receiving (chemo)-radiotherapy Treatment.
- ClinicalTrials.gov ID
- NCT05379712
- Acronym / sponsor ID
- IIT-0024
- Conditions
- Malnourishment, Nutritional Deficiency, Undernutrition
- Keywords
- Nutritional Support, Oral Nutritional Supplements
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- AHS Cancer Control AlbertaUniversity, hospital or other
- Study start
- 25 Oct 2024 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 18 May 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.
The purpose of this study is to determine whether multimodal nutrition therapy (primary nutrition intervention + adjuvant nutrition therapy) will support patients to optimize their total caloric intake during cancer treatment by measuring the difference in mean cumulative energy intake between the intervention and control group over the duration of cancer treatment.
Detailed description
This will be an randomized, open label, parallel assignment study during cancer treatment (Baseline - Week 7 for Primary endpoint) comparing multimodal oral nutrition therapy versus standard care. Starting at Week 8, all patients receive the intervention arm until study ends at Week 14. Patients in the intervention arm continue the intervention, patients on the standard care arm cross over to the intervention (deferred nutrition intervention).
The primary objective is to assess a multimodal nutrition therapy with two Medical Foods (primary nutrition intervention+ adjuvant nutrition therapy) with features adapted for patients with cancers of the head and neck receiving chemo-radiotherapy treatment, to maintain oral dietary intake during treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized (multimodal oral nutrition therapy versus standard care), open label, parallel assignment, during cancer treatment (Baseline - Week 7 for Primary endpoint). Starting at Week 8, all patients receive the intervention arm until study ends at Week 14. Patients in the intervention arm continue the intervention, patients on the standard care arm cross over to the intervention (deferred nutrition intervention).
| Arm | Type | Receives |
|---|---|---|
| Multimodal Nutrition Therapy | Experimental | Other: Resource® Support PlusTo assess a multimodal nutrition therapy (primary nutrition intervention+ adjuvant nutrition therapy) with features adapted for patients with cancers of the head and neck receiving chemo-radiotherapy treatment, to maintain oral dietary intake during treatment. The regimen consists of 2 medical foods, each taken on an unrestricted basis (as and when preferred by each patient). Resource® Support Plus, a nutritionally complete Medical Food specifically for the dietary management of oncology patients with (risk of) malnutrition. BOOST® Soothe, a Medical Food formulated as a clear oral nutritional supplement for cancer patients with sensory alterations or oral discomfort due to cancer treatments, in particular chemo- and/or radiotherapy. |
| Standard of Care | No intervention | –In this setting patients rely on oral dietary intake. Ordinary, commercially available ingredients and food products are consumed. The standard of care includes weekly consultation with specialist oncology Registered Dietitian. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients must have the ability to read, understand, and sign an informed consent and must be willing to comply with study treatment and follow-up.
- Male or female
- ≥18 years of age
- Histopathologically confirmed primary squamous cell carcinoma of the oral cavity and oropharynx, larynx or hypopharynx, who have agreed to receive radical intent radiotherapy as primary treatment or adjuvant treatment post-surgery, with or without platinum chemotherapy
- Capable of volitional oral nutritional intake at baseline.
Key exclusion criteria (8 listed)
- Fed by nasogastric tube, gastrostomy or total parenteral nutrition
- Cancer of the nasopharynx, thyroid or salivary gland
- Life expectancy <6 months.
- A known hypersensitivity / allergy to the investigational product or to any ingredient in their formulations (e.g. Milk/Lactose, Fish).
- Enrolment in any other clinical protocol or investigational study with an interventional agent or assessments that may interfere with study procedures.
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 |
|---|---|---|
| Resource® Support PlusNestlé Resource Support Plus® is a high energy- and protein-density Medical Food enriched with omega 3 polyunsaturated fatty acids. This is a nutritionally complete formula, in an easy to swallow, palatable, concentrated low volume, available in 2 flavours optimized for cancer patients undergoing chemotherapy and/or radiation in taste tests. It provides in a 125 mL serving: 250 kcal, 11.5 g protein and 0.95g of omega-3 fatty acid (eicosapentaenoic acid, EPA). | Other | Multimodal Nutrition Therapy |
Primary outcome
Change in mean cumulative energy intake
Time frame: Up to 14 weeks
Energy intake is calculated from a one-day diet record in which the patient lists the identity and quantity of all foods and beverages consumed in the designated 24 hour time period at the end of each week (Baseline - Week 14).
13 secondary outcomes
Change in mean cumulative protein take
Time frame: Up to 14 Weeks
Change in body weight (kg)
Time frame: Baseline-Week 14
Change in Nutritional blood biomarkers
Time frame: Baseline measures will be compared to levels at weeks 7 and 14
Head and Neck Symptom Checklist
Time frame: Up to 14 weeks
Taste and smell survey
Time frame: Up to 14 weeks
Medication use for pain
Time frame: Up to 14 weeks
Percent oral intake from oral nutritional supplements
Time frame: Up to 14 weeks
Product Sensory Assessment questionnaire
Time frame: Up to 14 weeks
Functional Assessment of Anorexia-Cachexia Treatment (FAACT) 5 Question Anorexia/Cachexia subscale (AC/S)
Time frame: Up to 14 weeks
Cumulative energy intake (kcal/kg BW)
Time frame: Up to 14 weeks
Cumulative protein take (g pro/kg BW)
Time frame: Up to 14 weeks
Change in computed-tomography (CT) defined skeletal muscle and fat mass)
Time frame: Within 30 days prior to start of treatment, Week 14
Tertiary hospital admission
Time frame: Up to 14 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- 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.
Vickie Baracos principal investigator
Cross Cancer Institute, Alberta Health Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Resource® Support Plus in people with Malnourishment and Nutritional Deficiency, run by AHS Cancer Control Alberta at 1 site in Canada.
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 7 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: looking for participants now, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vickie Baracos (780-432-8232, Vickie.Baracos@albertahealthservices.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mean cumulative energy intake (time frame: Up to 14 weeks). 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 28 Mar 2025; AzTrials last refreshed its copy on 26 Oct 2026.