头颈癌的营养补充
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.
研究概览
详细说明
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.
研究类型
注册 (估计的)
阶段
- 阶段2
联系人和位置
学习地点
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Alberta
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Edmonton、Alberta、加拿大、T6G 1Z2
- Cross Cancer Institute
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.)
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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. |
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). |
|
无干预：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. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in mean cumulative energy intake
大体时间：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). |
Up to 14 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in mean cumulative protein take
大体时间：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) |
Up to 14 Weeks
|
|
Change in body weight (kg)
大体时间：Baseline-Week 14
|
Change in weight (kg) from the previous week. |
Baseline-Week 14
|
|
Change in Nutritional blood biomarkers
大体时间：Baseline measures will be compared to levels at weeks 7 and 14
|
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
大体时间：Up to 14 weeks
|
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
大体时间：Up to 14 weeks
|
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
大体时间：Up to 14 weeks
|
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
大体时间：Up to 14 weeks
|
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
大体时间：Up to 14 weeks
|
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)
大体时间：Up to 14 weeks
|
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)
大体时间：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) |
Up to 14 weeks
|
|
Cumulative protein take (g pro/kg BW)
大体时间：Up to 14 weeks
|
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)
大体时间：Within 30 days prior to start of treatment, Week 14
|
Imaging for body composition (muscle, fat) |
Within 30 days prior to start of treatment, Week 14
|
|
Tertiary hospital admission
大体时间：Up to 14 weeks
|
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
|
合作者和调查者
调查人员
- 首席研究员：Vickie Baracos、Cross Cancer Institute, Alberta Health Services
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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