Nutritional Supplementation in Head and Neck Cancers

AHS Cancer Control Alberta

Status and phase: Enrolling; Phase 2

Conditions: Malnourishment; Undernutrition; Nutritional Deficiency

Treatments: Other: Resource® Support Plus

Study type: Interventional

Funder types: Other

Identifiers

NCT05379712

IIT-0024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 81 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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81 participants in 2 patient groups

Multimodal Nutrition Therapy

Experimental group

Description:

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.

Treatment:

Other: Resource® Support Plus

Standard of Care

No Intervention group

Description:

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.