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.
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Phase 2
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 control group over the duration of cancer treatment.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• 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
Locations
Other Locations
Canada
Cross Cancer Institute
RECRUITING
Edmonton
Contact Information
Primary
Vickie Baracos
Vickie.Baracos@albertahealthservices.ca
780-432-8232
Time Frame
Start Date:2024-10-25
Estimated Completion Date:2026-10
Participants
Target number of participants:81
Treatments
Experimental: Multimodal Nutrition Therapy
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.
No_intervention: Standard of Care
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.