Recruiting
Phase 2

Nutritional Supplementation

Sponsor:

AHS Cancer Control Alberta

Code:

NCT05379712

Conditions

Malnourishment

Nutritional Deficiency

Undernutrition

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Resource® Support Plus

Study Details

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

Study ID

NCT05379712

Start date

Oct 25, 2024

Status verified date

Oct, 2024

Completion date

Oct, 2026

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.)

Study Design

Enrollment

81 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Multimodal Nutrition Therapy

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.

no intervention: Standard of Care

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

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 measure

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

Central Contacts and Locations

Locations

Cross Cancer Institute

Recruiting

Edmonton, Alberta, Canada, T6G 1Z2

Contacts

More Information

Sponsor

AHS Cancer Control Alberta

Last update posted

Mar 28, 2025

Last verified

Oct, 2024

Keywords

  • Nutritional Support
  • Oral Nutritional Supplements

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by AHS Cancer Control Alberta on 2025-03-28.