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.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 81
- 试验地点
- 2
- 主要终点
- Change in mean cumulative energy intake
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.)
结局指标
主要结局
Change in mean cumulative energy intake
时间窗: Up to 14 weeks
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).
次要结局
- Change in mean cumulative protein take(Up to 14 Weeks)
- Change in body weight (kg)(Baseline-Week 14)
- Head and Neck Symptom Checklist(Up to 14 weeks)
- Change in Nutritional blood biomarkers(Baseline measures will be compared to levels at weeks 7 and 14)
- Medication use for pain(Up to 14 weeks)
- Functional Assessment of Anorexia-Cachexia Treatment (FAACT) 5 Question Anorexia/Cachexia subscale (AC/S)(Up to 14 weeks)
- Product Sensory Assessment questionnaire(Up to 14 weeks)
- Tertiary hospital admission(Up to 14 weeks)
- Cumulative energy intake (kcal/kg BW)(Up to 14 weeks)
- Percent oral intake from oral nutritional supplements(Up to 14 weeks)
- Taste and smell survey(Up to 14 weeks)
- Cumulative protein take (g pro/kg BW)(Up to 14 weeks)
- Change in computed-tomography (CT) defined skeletal muscle and fat mass)(Within 30 days prior to start of treatment, Week 14)