Effects of Intensive Nutritional Counseling on Nutritional Status and Quality of Life of Patients With Head and Neck Cancer Undergoing Radiation Therapy
试验速览
- 阶段
- 不适用
- 入组人数
- 90
- 试验地点
- 4
- 主要终点
- Change in quality of life
研究概览
简要总结
This study investigates the effects of nutritional counseling versus standard nutritional care on nutritional status and quality of life in patients with head and neck cancer submitted to radiotherapy.Half participants will receive intensive nutritional counseling while the other half will receive standard care.
详细描述
Considering that head and neck cancer patients usually present reduced food intake with consequent involuntary weight loss and significant worsening of quality of life, this study investigates the effects of nutritional counseling versus standard nutritional care on nutritional status and quality of life in patients with head and neck cancer submitted to radiotherapy.
Half participants (45) will receive intensive nutritional counseling, that is, once they are admitted to the study and once a week during radiotherapy, following the protocol of nutritional care to cancer patients in radiotherapy proposed by the American Dietetic Association (ADA).
The other half (45) will receive standard care, that is, nutritional counseling / education performed by hospital nurses and nutritional care performed by the hospital nutritionist (when there is a demand, usually 1 to 2 times during oncologic treatment).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 with head and neck cancer (oral cavity, oropharynx, hypopharynx and larynx); both sexes; aged 18 years and over, submitted to radiotherapy after chemotherapy or radiotherapy as a first-choice treatment or as adjuvant treatment (post-surgical).
排除标准
- •Patients using parenteral nutrition; without cognitive ability to understand the concepts of the questionnaires; in palliative radiotherapy.
研究组 & 干预措施
Intervention group
Intensive nutritional counseling: once they are admitted to the study and once a week during radiotherapy
干预措施: intensive nutritional counseling (Other)
Control group
Standard care: when there is demand, usually 1 to 2 times during radiotherapy
干预措施: Standard care (Other)
结局指标
主要结局
Change in quality of life
时间窗: Baseline and 12 weeks
Self reported quality of life assessed using two questionnaires - Functional Assessment of Cancer Therapy - Head and Neck (FACT-H \& N) and European Organization for Research and Treatment of Cancer - Quality of life questionnaire - Head and Neck (EORTC-QLQ-H \& N35).
Change in weight
时间窗: Baseline and 12 weeks
Defined as mean weight change
Change in nutritional status
时间窗: Baseline and 12 weeks
Defined as mean body mass index change
次要结局
- Energy and protein intake(Baseline and 12 weeks)
- Occurrence of complications due to radiotherapy(12 weeks)
- Fat free mass(Baseline and 12 weeks)
- Change in patient generated subjective global assessment(Baseline and 12 weeks)
- Occurrence of unplanned hospitalization(12 weeks)
- Occurrence of interruption or delay in treatment.(12 weeks)