Randomised Trial of the Effects of Individual Nutritional Counseling in Cancer Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Accumulated weight-change in per cent
研究概览
简要总结
Background and aims: Cancer-related malnutrition is multifactorial and related to a bad prognosis. The aim of this study was to investigate the effect of intensive, individual dietary counseling of patients in radiotherapy and/or chemotherapy for gynecologic-, gastric-, or esophageal cancer.
详细描述
The prospective, randomized controlled unblinded study with 61 consecutive outpatients. All patients were stratified according to primary disease (esophageal-, gastric- or gynecological cancer). Patients were randomised using tin foil-lined sealed envelopes by the authors. The sample size was calculated using 2α = 0.05, 1-β = 0.80, expected Standard Deviation (SD) (weight-loss-%) of 2.24 and the corresponding Minimal Relevant Difference of 1.75.
Due to different diagnoses and treatments, the duration of the participation in the study varied between 5 and 12 weeks (average 7.2 weeks). In all cases follow-up was performed three months after the end of treatment.
All patients randomized to receive nutritional intervention were counseled by the same dietitian at baseline, and once a week during treatment and at follow-up after three months. The goal of the nutritional counseling was an intake that met the protein and energy requirements according to Harris-Benedict equation multiplied with an individual activity factor (1,1-1,5) and a stress factor (1,0-1,1). Daily protein requirements were estimated to 1,5 g/kg per day. Dietary intake was evaluated by 24-hour-recall food questionnaires at baseline, every week, at the end of the study and at follow-up. On the basis of information from the 24-hour recall food questionnaires and supplementary comments patients were counseled on an individual basis with the purpose to minimize nutritional symptoms that may relate to cancer cachexia and the cancer treatment. The main elements of the counseling were to explain the importance of nutrition in relation to the patients present situation, to explain the targets and to agree on specific dietary goals to be fulfilled until the next session.
The control group was nutritionally instructed by the nurses with the possibility to call for a dietician if needed.
Apart from nutrition the patients had the same care and therapy, including treatment of pain and side-effects to the treatment.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult, consecutive outpatients referred for either palliative or preoperative chemotherapy and/or radiation therapy of cancers in the stomach or the pelvic area.
排除标准
- •Lack of ability to understand danish language and the instructions given
结局指标
主要结局
Accumulated weight-change in per cent
时间窗: up to 7.5 weeks
The primary end-points were accumulated weight-loss or -gain in per cent of the weight measured between inclusion and end of treatment and between end of treatment and follow-up, respectively.
次要结局
- Treatment related side effects and Quality of Life(up to 7.5 weeks)
研究者
Jens Rikardt Andersen
Associate Professor, Senior Physician
University of Copenhagen