Nutritional Supplementation in Head and Neck Cancers

Официальное название

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.

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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).

Первичные конечные точки

• Change in mean cumulative energy intake [Срок оценки: Up to 14 weeks]

Вторичные конечные точки (12)

• Change in mean cumulative protein take [Срок оценки: Up to 14 Weeks]
• Change in body weight (kg) [Срок оценки: Baseline-Week 14]
• Change in Nutritional blood biomarkers [Срок оценки: Baseline measures will be compared to levels at weeks 7 and 14]
• Head and Neck Symptom Checklist [Срок оценки: Up to 14 weeks]
• Taste and smell survey [Срок оценки: Up to 14 weeks]
• Medication use for pain [Срок оценки: Up to 14 weeks]
• Percent oral intake from oral nutritional supplements [Срок оценки: Up to 14 weeks]
• Product Sensory Assessment questionnaire [Срок оценки: Up to 14 weeks]
• Functional Assessment of Anorexia-Cachexia Treatment (FAACT) 5 Question Anorexia/Cachexia subscale (AC/S) [Срок оценки: Up to 14 weeks]
• Cumulative energy intake (kcal/kg BW) [Срок оценки: Up to 14 weeks]
• Cumulative protein take (g pro/kg BW) [Срок оценки: Up to 14 weeks]
• Change in computed-tomography (CT) defined skeletal muscle and fat mass) [Срок оценки: Within 30 days prior to start of treatment, Week 14]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• Cross Cancer Institute — Edmonton

Идентификаторы

NCT: NCT05379712 · IIT-0024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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