Can Protein Intake be Increased Using Whole Foods Post-treatment in Cancer Patients?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Difference in mean cumulative protein intake between the two groups at 8 weeks.
研究概览
简要总结
Cancer and its treatments often result in severe toxicities and side effects that, over the course of treatment, results in weight loss and depletion of key nutrients. Loss of muscle mass and strength during cancer treatment is a critical problem because it negatively affects patient response and tolerance to therapy and post-treatment recovery. To restore the nutritional status, it is imperative to stimulate muscle protein anabolism. Eggs are high quality protein source, popular and well tolerated by cancer patients. Therefore, the objective of this study is to determine whether a nutritional intervention of ≥2 eggs can aid in restoring nutritional status and improving immune function and quality of life of cancer patients' post-treatment. It is an 8- week randomised clinical trial with parallel arm assignment. Half of the participants will receive the nutritional intervention (Early Intervention) and the other half will be on standard of care or usual diet for first 4 weeks. Starting from week 5, all participants will receive the nutrition intervention till week 8 (Delayed Intervention). Dietary intake (foods and nutrients), cumulative protein intake (g protein/kg body weight), immunological measures, physical performance and quality of life has been planned to be assessed over time and between groups to evaluate the feasibility of an egg intervention in meeting recommended protein intakes for patients with cancer.
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
- •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.
- •≥18 years of age
- •Histopathologically confirmed cancer with receipt of a platinum chemotherapy during treatment; active treatment has concluded.
- •Capable of volitional oral semi-solid intake at baseline; able to maintain oral intake over the trial.
排除标准
- •Fed by nasogastric tube, gastrostomy, or total parenteral nutrition
- •Cancer of the brain, Cancer of the regions which impact an individual's ability to consume food.
- •A known hypersensitivity / allergy to eggs.
- •Enrolment in any other clinical protocol or investigational study that may interfere with study procedures.
- •Poorly controlled chronic illnesses or other inflammatory diseases (e.g. Chronic Obstructive Pulmonary Disease(COPD), uncontrolled non-insulin dependent diabetes, rheumatoid arthritis).
- •In a clinician opinion, patients who have medical conditions that could interfere with nutrient metabolism or absorption (e.g., short bowel syndrome, Crohn's disease, etc.)
结局指标
主要结局
Difference in mean cumulative protein intake between the two groups at 8 weeks.
时间窗: From baseline at 8 weeks
Mean cumulative protein intake will be arrived at by normalizing protein intake in kilocalories by body weight in kilograms
Difference in mean cumulative protein intake within a group at 8 weeks for each group.
时间窗: From baseline at 8 weeks
Mean cumulative protein intake will be arrived at by normalizing protein intake in kilocalories by body weight in kilograms
次要结局
- Change in Body weight(From baseline at 8 weeks)
- Change in Energy Intake(From baseline at 8 weeks)
- Change in Quality of Life(From baseline at 8 weeks)
- Change in Nutritional status and Symptom severity.(From baseline at 8 weeks)
- Change in Physical performance(From baseline at 8 weeks)
- Change in Quality of Life related to malnutrition(From baseline at 8 weeks)