Nutritional Supplementation in Head and Neck Cancers

Launched by AHS CANCER CONTROL ALBERTA · May 13, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at how a special nutrition program can help patients with head and neck cancers get enough calories during their treatment. The study will compare two groups: one group will receive a multimodal nutrition therapy, which includes different types of nutritional support, while the other group will not. The goal is to see if this nutrition therapy helps patients consume more calories, which is important for their recovery and overall health during cancer treatment.

To be eligible for this trial, participants need to be at least 18 years old and have a specific type of mouth or throat cancer that requires radiation treatment. They should be able to eat normally and have a recent CT scan to help doctors understand their condition. However, patients who are fed through a tube, have other types of cancers, or certain serious health issues may not qualify. If you join the trial, you'll receive guidance on your nutrition while your progress is monitored throughout your treatment. This study is currently recruiting participants, and it aims to find better ways to support the nutritional needs of cancer patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 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.
• • 2. Male or female
• • 3. ≥18 years of age
• • 4. 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
• • 5. Capable of volitional oral nutritional intake at baseline.
• • 6. 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.
• • 7. An Eastern Cooperative Oncology Group Performance Status of ≤ 2
• Exclusion Criteria:
• • 1. Fed by nasogastric tube, gastrostomy or total parenteral nutrition
• • 2. Cancer of the nasopharynx, thyroid or salivary gland
• • 3. Life expectancy \<6 months.
• • 4. A known hypersensitivity / allergy to the investigational product or to any ingredient in their formulations (e.g. Milk/Lactose, Fish).
• • 5. Enrolment in any other clinical protocol or investigational study with an interventional agent or assessments that may interfere with study procedures.
• • 6. Patients with untreated brain metastases (patients with previously resected and/or radiated brain metastases without neurologic symptoms are permitted).
• • 7. Poorly controlled chronic illnesses or other inflammatory diseases (e.g. COPD, uncontrolled non-insulin dependent diabetes, rheumatoid arthritis).
• • 8. 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.)