Nutritional Supplementation in Head and Neck Cancers

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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Nutritional Deficiency; Malnourishment; Undernutrition
• Intervention / Treatment: Other: Resource® Support Plus

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
• Enrollment (Estimated): 81
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Vickie Baracos; Phone Number: 780-432-8232; Email: Vickie.Baracos@albertahealthservices.ca

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Cross Cancer Institute
      • Contact: Vickie Baracos; Phone Number: 7804328232; Email: Vickie.Baracos@albertahealthservices.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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).
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in mean cumulative protein take	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
Change in body weight (kg)	Change in weight (kg) from the previous week.	Baseline-Week 14
Change in Nutritional blood biomarkers	A sample of blood will be collected for albumin, absolute neutrophil count, lymphocyte count, C-reactive protein, standard complete blood count-differential White Blood cell count and to measure serum CRP and albumin	Baseline measures will be compared to levels at weeks 7 and 14
Head and Neck Symptom Checklist	A survey tool for HNC patient self-assessment of the presence and degree of interference with eating, over the past 3 days, of 17 symptoms known to impact dietary intake. Scores range from 34 to 170 pts, where higher scores reflect a greater presence and interference with eating. Completed at weeks 0, 4, 7, 11, 14	Up to 14 weeks
Taste and smell survey	A survey tool for patient self-assessment of the presence, characterization and severity of taste and smell alterations. This tool yields a 'chemosensory complaint score' of up to 16 (greatest severity of taste and smell alterations). Completed at weeks 0, 4, 7, 11, 14.	Up to 14 weeks
Medication use for pain	Use of pain medication will be captured weekly by a one- day pain medication log.	Up to 14 weeks
Percent oral intake from oral nutritional supplements	The volume (mL) of study products consumed will be determined from the weekly one-day diet record.	Up to 14 weeks
Product Sensory Assessment questionnaire	A product evaluation form for the Medical Nutrition products will be used to evaluate product overall sensory assessment, including acceptance and perception of characteristic product attributes that influence overall sensory acceptance. Medical Nutrition sensory acceptance will be evaluated by "overall liking" on the 9-point hedonic scale (1= dislike extremely; 9 = like extremely). Completed at weeks 0, 2, 4, 6, 8, 10, 12, 14.	Up to 14 weeks
Functional Assessment of Anorexia-Cachexia Treatment (FAACT) 5 Question Anorexia/Cachexia subscale (AC/S)	The FAACT is a validated Quality of Life Scale to capture patient experience of cancer related cachexia - anorexia. Completed at weeks 0, 4, 7,11, 14	Up to 14 weeks
Cumulative energy intake (kcal/kg BW)	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
Cumulative protein take (g pro/kg BW)	Protein 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
Change in computed-tomography (CT) defined skeletal muscle and fat mass)	Imaging for body composition (muscle, fat)	Within 30 days prior to start of treatment, Week 14
Tertiary hospital admission	Review of patient medical records for instances of hospitalization with date(s) of admission falling between baseline and week 14 of study.	Up to 14 weeks

Collaborators and Investigators

• Sponsor: AHS Cancer Control Alberta
• Investigators: Principal Investigator: Vickie Baracos, Cross Cancer Institute, Alberta Health Services

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: May 13, 2022
• First Submitted That Met QC Criteria: May 13, 2022
• First Posted (Actual): May 18, 2022

Study Record Updates

• Last Update Posted (Actual): January 30, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Oral Nutritional Supplements; Nutritional Support
• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: IIT-0024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No