RecruitingPhase 2NCT05379712

Nutritional Supplementation in Head and Neck Cancers

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.


Sponsor

AHS Cancer Control Alberta

Enrollment

81 participants

Start Date

Oct 25, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at how nutritional support before and during radiotherapy can help patients with head and neck cancer — specifically mouth, throat, or voice box cancer — maintain their weight and health through treatment. **You may be eligible if...** - You are 18 or older with confirmed squamous cell carcinoma of the mouth, throat, voice box, or nasal passages - You are receiving radiotherapy as your main treatment (with or without chemotherapy), either before or after surgery - You are still able to eat and drink by mouth at the start of the study - A baseline CT scan was taken within 30 days before starting radiotherapy **You may NOT be eligible if...** - You cannot eat or drink by mouth at baseline - You are unable to give informed consent - You do not meet the imaging and laboratory requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERResource® Support Plus

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).


Locations(1)

Cross Cancer Institute

Edmonton, Alberta, Canada

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NCT05379712


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