Nutritional Supplementation in Head and Neck Cancers

Recruiting now · Phase 2

Conditions studied: Malnourishment, Nutritional Deficiency, Undernutrition

In brief

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.

Key facts

Study ID

NCT05379712

Run by

AHS Cancer Control Alberta

People needed

81

Starts

2024-10-25

Expected to finish

2026-10-01

Last updated by the study team

2025-03-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.)

Where it is running

• Cross Cancer Institute — Edmonton, Alberta, Canada (enrolling)

Full record on ClinicalTrials.gov

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