NCT02159508Unknown不适用
An Intervention Study Comparing Intensive Nutrition Counselling With On-demand Counselling in Patients With Head and Neck Cancer Undergoing Chemoradiotherapy
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Nutritional status
研究概览
简要总结
The purpose of this study is to assess the effect of a pre-planned patient-adjusted intensive nutritional counselling given by a dietitian several times during (chemo)radiotherapy vs. individualized nutritional counselling given by a dietitian once in the beginning of (chemo)radiotherapy and thereafter on-demand in patients with head and neck squamous cell cancer.
详细描述
- A sample size of 102 patients was identified to achieve 30% reduction in prevalence of malnutrition at the end of treatment (50% to 20%), with a significance value of 5% (p < 0.05), 90% power. The second calculation was for a sample size of 88 patients for 30% reduction in prevalence of malnutrition at the end of treatment (50% to 20%) with the significance value 5% (p<0.05), 85% power and effect size 70%. Based on these numbers, our aim is to recruit 100 patients, with the assumption that 12% patients would be lost to follow up.
- Randomization will be performed by the minimization procedure with the Minim Program® (http://www-users.york.ac.uk/\~mb55/guide/randsery.htm). The allocation will be done according to the following criteria: 1) Stage I-II vs. Stage III-IV; 2) age <65 vs. >=65 year; 3) Body Mass Index <20 vs. >=20 kg/m2 and 4) tumour location (oral cavity-oropharynx-tonsils vs. hypopharynx-larynx vs. nasopharynx).
- Adverse events of chemoradiotherapy will be classified according to the National Cancer Institute Common Terminology Criteria for Adverse Events-3.0 (CTCAE v3.0)
- Nutritional status will be assessed by patient-generated subjective global assessment, nutritional risk screening-2002, upper-arm anthropometry (MAC, triceps skinfold thickness, MAMA), Bio-impedance, hand grip strength and weight loss.
- Survival: overall survival, disease-specific survival and disease-free survival are calculated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of primary locally advanced squamous cell carcinoma of the oral cavity, pharynx, nasopharynx or larynx
排除标准
- •renal function impairment
- •liver insufficiency
- •heart failure
- •pulmonal impairment
- •Chronic obstructive pulmonary disease
- •cognitive impairment
- •previous cancer in any location
- •terminal stage
结局指标
主要结局
Nutritional status
时间窗: 6 months
Nutritional status was assessed by patient-generated subjective global assessment and anthropometry.
次要结局
- Survival(5 year)
研究者
Helena Orell-Kotikangas
Dietitian
Helsinki University Central Hospital
研究点 (2)
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