Nutritional Supplementation in Head and Neck Cancers

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.

Overview

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.

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.

Interventions

• Other Resource® Support Plus
  Nestlé Resource Support Plus® is a high energy- and protein-density Medical Food enriched with omega 3 polyunsaturated fatty acids. This is a nutritionally complete formula, in an easy to swallow, palatable, concentrated low volume, available in 2 flavours optimized for cancer patients undergoing chemotherapy and/or radiation in taste tests. It provides in a 125 mL serving: 250 kcal, 11.5 g protein and 0.95g of omega-3 fatty acid (eicosapentaenoic acid, EPA).

Primary outcome measures

• Change in mean cumulative energy intake [Time frame: Up to 14 weeks]

Secondary outcome measures (12)

• Change in mean cumulative protein take [Time frame: Up to 14 Weeks]
• Change in body weight (kg) [Time frame: Baseline-Week 14]
• Change in Nutritional blood biomarkers [Time frame: Baseline measures will be compared to levels at weeks 7 and 14]
• Head and Neck Symptom Checklist [Time frame: Up to 14 weeks]
• Taste and smell survey [Time frame: Up to 14 weeks]
• Medication use for pain [Time frame: Up to 14 weeks]
• Percent oral intake from oral nutritional supplements [Time frame: Up to 14 weeks]
• Product Sensory Assessment questionnaire [Time frame: Up to 14 weeks]
• Functional Assessment of Anorexia-Cachexia Treatment (FAACT) 5 Question Anorexia/Cachexia subscale (AC/S) [Time frame: Up to 14 weeks]
• Cumulative energy intake (kcal/kg BW) [Time frame: Up to 14 weeks]
• Cumulative protein take (g pro/kg BW) [Time frame: Up to 14 weeks]
• Change in computed-tomography (CT) defined skeletal muscle and fat mass) [Time frame: Within 30 days prior to start of treatment, Week 14]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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.)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Open label

Primary purpose

Treatment

Study locations

Canada · 1 center

• Cross Cancer Institute — Edmonton

Identifiers

NCT: NCT05379712 · IIT-0024

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗