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Clinical 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 control group over the duration of cancer treatment.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT05379712
Study type Interventional
Source AHS Cancer Control Alberta
Contact Vickie Baracos
Phone 780-432-8232
Email Vickie.Baracos@albertahealthservices.ca
Status Not yet recruiting
Phase Phase 2
Start date July 2024
Completion date October 2025

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