Feasibility, Acceptability, and Effectiveness of an Individualized Plant-based (iPLANT) Diet Plan in Colorectal Cancer: Mixed Method Embedded Design
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 92
- 试验地点
- 4
- 主要终点
- Change from baseline in mean neutrophil-lymphocyte ratio at 12 weeks
研究概览
简要总结
The goal of this intervention study is to investigate the effectiveness of individualized plant-based diet plan on nutritional indices and clinical outcomes in colorectal cancer patients receiving chemotherapy. The main questions to answer are:
- What are the current eating trends in colorectal cancer patients?
- What are the common perceptions of adopting a plant-based diet in colorectal cancer?
- Does iPLANT diet plan improve nutritional indices of colorectal cancer patients?
- Does iPLANT diet plan improve patients' gastrointestinal side effects and quality of life without compromising their nutritional status?
Participants will be randomly assigned into two arms (intervention and control) using opaque envelop system. Intervention group will receive individualized plant-based diet plan and diet counselling, whereas the control group will receive usual diet counselling.
The researcher will compare the differences in nutritional outcomes and quality of life between intervention and control groups before and after intervention.
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
- •Diagnosed with colorectal cancer, including the sites of caecum, appendix, ascending colon, hepatic flexure, transverse colon, splenic flexure, descending colon, sigmoid colon, and rectum
- •TNM stage II to IV
- •Receiving chemotherapy
- •Able to take food orally
排除标准
- •Have cognitive impairments or mental disorders
- •Diagnosed with severe illness, such as chronic kidney disease and chronic obstructive pulmonary disease
- •Within 4 weeks of bowel resection
- •Terminally ill or receive hospice care
- •Receiving enteral or total parenteral nutrition
- •Having inflammatory bowel diseases
- •Having gastrointestinal bleeding or obstruction
- •Pregnancy or breastfeeding
- •Severe anemia (<0.8g/dL)
- •ECOG performance score >2
- •High stoma output (>1500ml per day)
研究组 & 干预措施
Intervention group
Receive iPLANT diet plan and diet counselling by a qualified dietitian in oncology setting.
干预措施: iPLANT diet plan and diet counselling (Behavioral)
Control group
Receive usual diet counselling only
干预措施: Usual diet counselling (Behavioral)
结局指标
主要结局
Change from baseline in mean neutrophil-lymphocyte ratio at 12 weeks
时间窗: Change from baseline to week 12
Higher score indicates higher level of inflammation
Change from baseline in mean platelet-lymphocyte ratio at 12 weeks
时间窗: Change from baseline to week 12
Higher score indicates higher level of inflammation
Change from baseline in mean Prognostic Nutritional Index at 12 weeks
时间窗: Change from baseline to week 12
The Prognostic Nutritional Index is used to assess the nutritional status. Respondents are severely malnourished if score less than 40
次要结局
- Change from baseline in mean handgrip strength at 12 weeks(Change from baseline to week 12)
- Change in mean daily energy and protein intake at 12 weeks(Change from baseline to week 12)
- Change from baseline in mean mid arm muscle area at 12 weeks(Change from baseline to week 12)
- Change from baseline in mean Patient-Generated Subjective Global Assessment score at 12 weeks(Change from baseline to week 12)
- Change from baseline in mean skeletal muscle Index, body fat mass, extracellular water ratio, phase angle at 12 weeks(Change from baseline to week 12)
- Change from baseline in mean quality of Life at 12 weeks(Change from baseline to week 12)
研究者
Krystal Ng Lu Shin
Principal Investigator
National Cancer Institute, Malaysia