Clinical trial NCT05379712: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Malnourishment
Nutritional Deficiency
Undernutrition
Keywords: Nutritional Support
Oral Nutritional Supplements
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
First posted: 2022-05-18
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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).
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.)

Primary outcomes:
measure: Change in mean cumulative energy intake
timeFrame: Up to 14 weeks
Secondary outcomes:
measure: Change in mean cumulative protein take
timeFrame: Up to 14 Weeks
measure: Change in body weight (kg)
timeFrame: Baseline-Week 14
measure: Change in Nutritional blood biomarkers
timeFrame: Baseline measures will be compared to levels at weeks 7 and 14
measure: Head and Neck Symptom Checklist
timeFrame: Up to 14 weeks
measure: Taste and smell survey
timeFrame: Up to 14 weeks
measure: Medication use for pain
timeFrame: Up to 14 weeks
measure: Percent oral intake from oral nutritional supplements
timeFrame: Up to 14 weeks
measure: Product Sensory Assessment questionnaire
timeFrame: Up to 14 weeks
measure: Functional Assessment of Anorexia-Cachexia Treatment (FAACT) 5 Question Anorexia/Cachexia subscale (AC/S)
timeFrame: Up to 14 weeks
measure: Cumulative energy intake (kcal/kg BW)
timeFrame: Up to 14 weeks
measure: Cumulative protein take (g pro/kg BW)
timeFrame: Up to 14 weeks
measure: Change in computed-tomography (CT) defined skeletal muscle and fat mass)
timeFrame: Within 30 days prior to start of treatment, Week 14
measure: Tertiary hospital admission
timeFrame: Up to 14 weeks
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
Study officials:
affiliation: Cross Cancer Institute, Alberta Health Services
name: Vickie Baracos
role: PRINCIPAL_INVESTIGATOR
References: