A Phase 2 interventional study of Resource® Support Plus in Malnourishment, Nutritional Deficiency and Undernutrition, sponsored by AHS Cancer Control Alberta. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-28.
Sponsored by AHS Cancer Control Alberta · Phase 2, Interventional, and 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.
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.
1,587 studies on the registry are indexed under Malnutrition; 237 are open to participants now.
This study's planned enrollment of 81 is close to the median of 90 across 1,134 interventional studies indexed under Malnutrition.
Browse Malnutrition studies →AHS Cancer Control Alberta is the lead sponsor of 182 studies on the registry; 31 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Other: Resource® Support Plus
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.
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).
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).
Time frame: Up to 14 weeks
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)
Time frame: Up to 14 Weeks
Change in body weight (kg)
Change in weight (kg) from the previous week.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: Up to 14 weeks
Medication use for pain
Use of pain medication will be captured weekly by a one- day pain medication log.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: Up to 14 weeks
Change in computed-tomography (CT) defined skeletal muscle and fat mass)
Imaging for body composition (muscle, fat)
Time frame: 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.
Time frame: Up to 14 weeks
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
AHS Cancer Control Alberta