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NCT05379712 | RECRUITING | Malnourishment

Nutritional Supplementation in Head and Neck Cancers
Sponsor:

AHS Cancer Control Alberta

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.

Condition or disease

Malnourishment

Nutritional Deficiency

Undernutrition

Intervention/treatment

Resource® Support Plus

Phase

PHASE2

Detailed Description:

This will be an randomized, open label, parallel assignment study during cancer treatment (Baseline - Week 7 for Primary endpoint) comparing multimodal oral nutrition therapy versus standard care. Starting at Week 8, all patients receive the intervention arm until study ends at Week 14. Patients in the intervention arm continue the intervention, patients on the standard care arm cross over to the intervention (deferred nutrition intervention). The primary objective is to assess a multimodal nutrition therapy with two Medical Foods (primary nutrition intervention+ adjuvant nutrition therapy) with features adapted for patients with cancers of the head and neck receiving chemo-radiotherapy treatment, to maintain oral dietary intake during treatment.

Study Type : INTERVENTIONAL
Estimated Enrollment : 81 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : 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.
Actual Study Start Date : 2024-10-25
Estimated Primary Completion Date : 2026-10
Estimated Study Completion Date : 2026-10

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.)
Nutritional Supplementation in Head and Neck Cancers

Location Details

NCT05379712

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Locations

RECRUITING

Canada, Alberta

Cross Cancer Institute

Edmonton, Alberta, Canada, T6G 1Z2