Trial Summary
What is the purpose of this trial?
This trial tests a special diet plan to help head and neck cancer patients eat enough. The diet includes two types of medical foods designed to provide necessary calories and nutrients, making it easier for patients to maintain their energy levels.
Research Team
VB
Vickie Baracos
Principal Investigator
Cross Cancer Institute, Alberta Health Services
Eligibility Criteria
This trial is for adults over 18 with squamous cell carcinoma of the oral cavity, oropharynx, larynx, or hypopharynx planning to undergo radical radiotherapy. They must be able to eat orally and have a performance status indicating they can carry out some activity. Excluded are those with certain other cancers, on conflicting trials, using tube feeding, having conditions affecting nutrient metabolism/absorption, untreated brain metastases, severe chronic illnesses or allergies to trial supplement ingredients.Inclusion Criteria
I can eat and drink on my own without help.
I am 18 years old or older.
I have a confirmed diagnosis of squamous cell carcinoma in the mouth or throat area and will undergo intensive radiotherapy.
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Exclusion Criteria
I have brain metastases that haven't been treated, or I've had treatment without current symptoms.
Enrolment in any other clinical protocol or investigational study with an interventional agent or assessments that may interfere with study procedures
Life expectancy <6 months
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Treatment Details
Interventions
- Multimodal Nutrition Therapy (Other)
- Resource® Support Plus (Behavioural Intervention)
Trial OverviewThe study tests if multimodal nutrition therapy helps patients maintain their calorie intake during cancer treatment. It compares the average energy consumed by patients receiving primary nutrition intervention plus adjuvant therapy (Resource® Support Plus) against a control group throughout their treatment period.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Multimodal Nutrition TherapyExperimental Treatment1 Intervention
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.
Group II: Standard of CareActive Control1 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.
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Who Is Running the Clinical Trial?
AHS Cancer Control Alberta
Lead Sponsor
Trials
188
Recruited
26,900+
Dr. Peter Jamieson
AHS Cancer Control Alberta
Chief Medical Officer since 2024
MD from the University of Alberta
Andre Tremblay
AHS Cancer Control Alberta
Chief Executive Officer
BA in Political Science from the University of Victoria, MA in Political Science from the University of British Columbia