Nutritional Supplementation in Head and Neck Cancers

NCT05379712 | Recruiting Phase 2 DMC

• 1 other identifier: IIT-0024
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

Malnourishment; Nutritional Deficiency; Undernutrition

Keywords

Nutritional Support; Oral Nutritional Supplements

Outcome Measures

Primary Outcomes (1)

• Change in mean cumulative energy intake

  Energy intake is calculated from a one-day diet record in which the patient lists the identity and quantity of all foods and beverages consumed in the designated 24 hour time period at the end of each week (Baseline - Week 14).

  Up to 14 weeks

Secondary Outcomes (13)

• Change in mean cumulative protein take

  Up to 14 Weeks

• Change in body weight (kg)

  Baseline-Week 14

• Change in Nutritional blood biomarkers

  Baseline measures will be compared to levels at weeks 7 and 14

• Head and Neck Symptom Checklist

  Up to 14 weeks

• Taste and smell survey

  Up to 14 weeks

Study Arms (2)

Multimodal Nutrition Therapy

EXPERIMENTAL

To assess a multimodal nutrition therapy (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. The regimen consists of 2 medical foods, each taken on an unrestricted basis (as and when preferred by each patient). Resource® Support Plus, a nutritionally complete Medical Food specifically for the dietary management of oncology patients with (risk of) malnutrition. BOOST® Soothe, a Medical Food formulated as a clear oral nutritional supplement for cancer patients with sensory alterations or oral discomfort due to cancer treatments, in particular chemo- and/or radiotherapy.

Other: Resource® Support Plus

Standard of Care

NO INTERVENTION

In this setting patients rely on oral dietary intake. Ordinary, commercially available ingredients and food products are consumed. The standard of care includes weekly consultation with specialist oncology Registered Dietitian.

Interventions

Resource® Support Plus OTHER

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).

Multimodal Nutrition Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• AHS Cancer Control Alberta: lead

Study Sites (1)

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

RECRUITING

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Vickie Baracos

  Cross Cancer Institute, Alberta Health Services

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vickie Baracos

CONTACT

780-432-8232; Vickie.Baracos@albertahealthservices.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized (multimodal oral nutrition therapy versus standard care), open label, parallel assignment, during cancer treatment (Baseline - Week 7 for Primary endpoint). 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).

Study Record Dates

• First Submitted: May 13, 2022
• First Posted: May 18, 2022
• Study Start: October 25, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 28, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)