Who is eligible for clinical trial NCT05379712?

Participants must meet protocol criteria for Malnourishment. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT05379712 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2025-03-25

Nutritional Supplementation in Head and Neck Cancers (NCT05379712)

🟢 Recruiting Phase2 📋 Clinical Research Protocol Sponsor: AHS Cancer Control Alberta

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (9 items).

Location: Cross Cancer Institute — Edmonton, Alberta

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
Fed by nasogastric tube, gastrostomy or total parenteral nutrition
Cancer of the nasopharynx, thyroid or salivary gland
Life expectancy \<6 months.
A known hypersensitivity / allergy to the investigational product or to any ingredient in their formulations (e.g. Milk/Lactose, Fish).
Enrolment in any other clinical protocol or investigational study with an interventional agent or assessments that may interfere with study procedures.
Patients with untreated brain metastases (patients with previously resected and/or radiated brain metastases without neurologic symptoms are permitted).
Poorly controlled chronic illnesses or other inflammatory diseases (e.g. COPD, uncontrolled non-insulin dependent diabetes, rheumatoid arthritis).
In the investigators' opinion, patients who have medical conditions that could interfere with nutrient metabolism or absorption (e.g., short bowel syndrome, Crohn's disease, etc.)

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

Cross Cancer Institute — Edmonton, Alberta

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗