NCT05379712 Nutritional Supplementation in Head and Neck Cancers
| NCT ID | NCT05379712 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | AHS Cancer Control Alberta |
| Condition | Malnourishment |
| Study Type | INTERVENTIONAL |
| Enrollment | 81 participants |
| Start Date | 2024-10-25 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 81 participants in total. It began in 2024-10-25 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.)
Contact & Investigator
Vickie Baracos
PRINCIPAL INVESTIGATOR
Cross Cancer Institute, Alberta Health Services
Frequently Asked Questions
Who can join the NCT05379712 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Malnourishment. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05379712 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05379712 currently recruiting?
Yes, NCT05379712 is actively recruiting participants. Contact the research team at Vickie.Baracos@albertahealthservices.ca for enrollment information.
Where is the NCT05379712 trial being conducted?
This trial is being conducted at Edmonton, Canada.
Who is sponsoring the NCT05379712 clinical trial?
NCT05379712 is sponsored by AHS Cancer Control Alberta. The principal investigator is Vickie Baracos at Cross Cancer Institute, Alberta Health Services. The trial plans to enroll 81 participants.