Integrative Nutrition Care Plan for the Patient With Liver and Colorectal Cancer

Study Overview
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Brief Summary
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At present, the families of cancer patients are lack knowledge and experience of nutritional care after discharge. As a result, cancer patients often suffer from low nutritional status after being discharged from the hospital.

Detailed Description
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This study intends to design a home nutrition care plan to explore the effect of a home nutrition care plan on the nutritional status of patients with liver cancer and colorectal cancer at risk of malnutrition. Malnutrition or side effects often lead to natural food intake for patients. It is not enough to meet the nutritional requirements, so it is matched with dietary products to help patients more easily meet their nutritional requirements. Supplements are used to alleviate patients' side effects. It is hoped that they can help patients improve their nutritional status.

Official Title
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Integrative Nutrition Care Plan for the Patient With Liver and Colorectal Cancer

Conditions
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Malnutrition, Cancer of Colon, Cancer of Liver, Nutrition Aspect of Cancer

Intervention / Treatment
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* Behavioral: Nutritional consultant
* Dietary Supplement: Nutritional consultant + High-calorie, high-protein liquid nutrition supplement
* Combination Product: Nutritional consultant + Liquid supplement + Powdered supplement 1 and 2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with liver cancer or colorectal cancer stage I to III Not suffering from other carcinomas in situ at the same time Will undergo surgery or non-surgical cancer treatment Can move, read and answer questions by itself At least one social support (family or friend) to assist and support the patient to complete the trial According to the aPG-SGA, the assessment score is between 4   9 The patient or caregiver can cooperate with the dietitian to track and answer related questions asked by the dietitian in a remote way through communication software or telephone every week. Able to adjust diet or take nutrition and supplements daily with the guidance of a nutritionist Be able to cooperate with doctors and the beginning of the study and monthly return visits and blood tests for health insurance items Exclusion Criteria: Perform organ transplantation or palliative care Hepatic encephalopathy History of cardiovascular and cerebrovascular diseases Severe organ failure of the heart, breathing, or kidneys History of digestive tract inflammation or ulcer Severe mental illness An active infectious diseases Those who can only use intravenous nutrition and cannot use enteral nutrition People who are allergic to product ingredients (milk, soy, or mango and their products) Unwilling to cooperate with dietitians to make dietary adjustments or supplement nutrition and supplements Unwilling to actively treat cancer

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group<br>Consulted by the dietitian using communication software (Line) or telephone. At 0.5, 1, 1.5, 2, 2.5, and 3 months will track the biochemical data, assess nutritional status and quality of life. The nutrition care plan period will be three months. | Behavioral: Nutritional consultant<br>* The control group is to be consulted by the dietitian using communication software (Line) or telephone to evaluate the nutritional requirement and guide the cancer diet principles before starting the project.<br>|
| Experimental: Nutrition care plan group A<br>Consulted by the dietitian using communication software (Line) or telephone. Implement a daily diet with a concentrated high-calorie and high-protein liquid supplement At 0.5, 1, 1.5, 2, 2.5, and 3 months will track the biochemical data, assess nutritional status and quality of life. 3.The nutrition care plan period will be three months. | Behavioral: Nutritional consultant<br>* The control group is to be consulted by the dietitian using communication software (Line) or telephone to evaluate the nutritional requirement and guide the cancer diet principles before starting the project.<br>Dietary Supplement: Nutritional consultant + High-calorie, high-protein liquid nutrition supplement<br>* At the beginning of the plan, the dietitian first calculates the patient's daily calorie intake and the ratio of the three macronutrients and guides the patients or their family members of the nutritional care plan group A to implement a daily diet with a concentrated high-calorie and high-protein liquid supplement (Commercial formula contains 425 kcal and 19.1 grams of protein).<br>|
| Experimental: Nutrition care plan group B<br>Consulted by the dietitian using communication software (Line) or telephone. Implement a daily diet with a concentrated high-calorie and high-protein liquid supplement and powdered supplement 1 and nutritional products and powdered supplement 2 At 0.5, 1, 1.5, 2, 2.5, and 3 months will track the biochemical data, assess nutritional status and quality of life. The nutrition care plan period will be three months. | Behavioral: Nutritional consultant<br>* The control group is to be consulted by the dietitian using communication software (Line) or telephone to evaluate the nutritional requirement and guide the cancer diet principles before starting the project.<br>Combination Product: Nutritional consultant + Liquid supplement + Powdered supplement 1 and 2<br>* At the beginning of the plan, the dietitian first calculates the patient's daily calorie intake and the ratio of the three macronutrients and guides the patients or their family members of the nutritional care plan group B to implement a daily diet with a concentrated high-calorie and high-protein liquid supplement (Commercial formula contains 425 kcal and 19.1 grams of protein). Meanwhile, nutrition care plan group B will be given powdered supplement 1 (containing β-glucan and gamma-aminobutyric acid) and nutritional products and powdered supplement 2 (contains water-soluble dietary fiber and probiotics).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate nutritional status indicators change | Improvement of nutritional status indicators: Abridged Patient-Generated Subjective Global Assessment (aPG-SGA) assessment scores. | Baseline and at 0.5th month | 
| Evaluate nutritional status indicators change | Improvement of nutritional status indicators: Abridged Patient-Generated Subjective Global Assessment (aPG-SGA) assessment scores. | Baseline and at 1st month | 
| Evaluate nutritional status indicators change | Improvement of nutritional status indicators: Abridged Patient-Generated Subjective Global Assessment (aPG-SGA) assessment scores. | Baseline and at 1.5th month | 
| Evaluate nutritional status indicators change | Improvement of nutritional status indicators: Abridged Patient-Generated Subjective Global Assessment (aPG-SGA) assessment scores. | Baseline and at 2nd month | 
| Evaluate nutritional status indicators change | Improvement of nutritional status indicators: Abridged Patient-Generated Subjective Global Assessment (aPG-SGA) assessment scores. | Baseline and at 2.5th month | 
| Evaluate nutritional status indicators change | Improvement of nutritional status indicators: Abridged Patient-Generated Subjective Global Assessment (aPG-SGA) assessment scores. | Baseline and at third month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate anthropometric measurements change-Body weight | Weight in kilograms | Baseline and at 0.5th, 1st, 1.5th, 2nd, 2.5th, and third month | 
| Evaluate anthropometric measurements change-Body mass index(BMI) | Weight and height will be combined to report BMI in kg/m^2 | Baseline and at 0.5th, 1st, 1.5th, 2nd, 2.5th, and third month | 
| Evaluate biochemical data change-White blood cells (WBC) | White blood cells (x10^3/ul) | Baseline and at 1st, 2nd, and third month | 
| Evaluate biochemical data change-Red blood cells (RBC) | Red blood cells (x10^6/ul) | Baseline and at 1st, 2nd, and third month | 
| Evaluate biochemical data change-Hemoglobin (Hb) | Hemoglobin (g/dl) | Baseline and at 1st, 2nd, and third month | 
| Evaluate biochemical data change-Hematocrit (Hct) | Hematocrit (%) | Baseline and at 1st, 2nd, and third month | 
| Evaluate biochemical data change-Platelet | Platelet (x10^3/ul) | Baseline and at 1st, 2nd, and third month | 
| Evaluate biochemical data change-Mean corpuscular volume (MCV) | Mean corpuscular volume (fl) | Baseline and at 1st, 2nd, and third month | 
| Evaluate biochemical data change-Mean corpuscular hemoglobin (MCH) | Mean corpuscular hemoglobin (pg) | Baseline and at 1st, 2nd, and third month | 
| Evaluate biochemical data change-Mean corpuscular hemoglobin concentration (MCHC) | Mean corpuscular hemoglobin concentration (g/dl) | Baseline and at 1st, 2nd, and third month | 
| Evaluate biochemical data change-Neutrophil band | Neutrophils (%), Lymphocyte (%), Monocyte (%), Eosinophil (%), and Basophil (%) | Baseline and at 1st, 2nd, and third month | 
| Evaluate biochemical data change-renal function | Blood urea nitrogen and Creatinine (mg/dl) | Baseline and at 1st, 2nd, and third month | 
| Evaluate biochemical data change-Albumin (Alb) | Albumin (g/dl) | Baseline and at 1st, 2nd, and third month | 
| Evaluate biochemical data change-liver function | Aspartate aminotransferase and Alanine aminotransferase (U/l) | Baseline and at 1st, 2nd, and third month | 
| Evaluate biochemical data change-renal function | estimated Glomerular filtration rate (eGFR) (mL/min/1.73 m^2) | Baseline and at 1st, 2nd, and third month | 
| Evaluate biochemical data change-lipid profile | Triglyceride, Total cholesterol, Low-density lipoprotein cholesterol, High-density lipoprotein cholesterol (mg/dl) | Baseline and third month | 
| Evaluate food intake change (energy) | Use 24-hour dietary recall to evaluate the nutrition intake (energy in calories) | Baseline and at 0.5th, 1st, 1.5th, 2nd, 2.5th, and third month | 
| Evaluate food intake change (protein) | Use 24-hour dietary recall to evaluate the nutrition intake (protein in grams) | Baseline and at 0.5th, 1st, 1.5th, 2nd, 2.5th, and third month | 
| Evaluate quality of life indicators change | Scores on the Quality of Life Scale (European Organization for Research and Treatment of Cancer quality of life questionnaires core 30, EORTC QLQ-C30) | Baseline and at 0.5th, 1st, 1.5th, 2nd, 2.5th, and third month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nutrition care of cancer, Liver cancer, Colorectal cancer, Remote consultation, Nutrition supplement