Nutritional support for patients with 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.
This study is testing if a special nutrition program can help people with head and neck cancers eat better during their treatment compared to regular care.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 81 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AHS Cancer Control Alberta Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Edmonton, Alberta) |
| Trial ID | NCT05379712 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of multimodal nutrition therapy in improving caloric intake for patients undergoing treatment for head and neck cancers. It is a randomized, open-label trial comparing a specialized oral nutrition intervention to standard care during the initial weeks of cancer treatment. After the first phase, all participants will receive the nutritional intervention to assess its impact on maintaining dietary intake. The primary goal is to determine the difference in energy intake between the two groups over the treatment period.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with confirmed squamous cell carcinoma of the oral cavity, oropharynx, larynx, or hypopharynx who are set to receive radical radiotherapy.
Not a fit: Patients who are fed by nasogastric tube, gastrostomy, or total parenteral nutrition will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance nutritional status and overall treatment outcomes for patients with head and neck cancers.
How similar studies have performed: Other studies have shown promising results with multimodal nutritional interventions in cancer care, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.)
Where this trial is running
Edmonton, Alberta
- Cross Cancer Institute — Edmonton, Alberta, Canada (Recruiting)
Study contacts
- Principal investigator: Vickie Baracos — Cross Cancer Institute, Alberta Health Services
- Study coordinator: Vickie Baracos
- Email: Vickie.Baracos@albertahealthservices.ca
- Phone: 780-432-8232
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.