Cancer of Colon, Cancer of Liver, Malnutrition, Nutrition Aspect of Cancer
Conditions
Keywords
Nutrition care of cancer, Liver cancer, Colorectal cancer, Remote consultation, Nutrition supplement
Brief summary
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
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.
Interventions
BEHAVIORALNutritional consultant
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.
DIETARY_SUPPLEMENTNutritional consultant + High-calorie, high-protein liquid nutrition supplement
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).
COMBINATION_PRODUCTNutritional consultant + Liquid supplement + Powdered supplement 1 and 2
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).
Sponsors
Taipei Medical University WanFang Hospital
Taipei Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with liver cancer or colorectal cancer stage I to III 2. Not suffering from other carcinomas in situ at the same time 3. Will undergo surgery or non-surgical cancer treatment 4. Can move, read and answer questions by itself 5. At least one social support (family or friend) to assist and support the patient to complete the trial 6. According to the aPG-SGA, the assessment score is between 4 \ 9 7. 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. 8. Able to adjust diet or take nutrition and supplements daily with the guidance of a nutritionist 9. 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
1. Perform organ transplantation or palliative care 2. Hepatic encephalopathy 3. History of cardiovascular and cerebrovascular diseases 4. Severe organ failure of the heart, breathing, or kidneys 5. History of digestive tract inflammation or ulcer 6. Severe mental illness 7. An active infectious diseases 8. Those who can only use intravenous nutrition and cannot use enteral nutrition 9. People who are allergic to product ingredients (milk, soy, or mango and their products) 10. Unwilling to cooperate with dietitians to make dietary adjustments or supplement nutrition and supplements 11. Unwilling to actively treat cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate nutritional status indicators change | Baseline and at 0.5th month | Improvement of nutritional status indicators: Abridged Patient-Generated Subjective Global Assessment (aPG-SGA) assessment scores. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate anthropometric measurements change-Body mass index(BMI) | Baseline and at 0.5th, 1st, 1.5th, 2nd, 2.5th, and third month | Weight and height will be combined to report BMI in kg/m\^2 |
| Evaluate biochemical data change-White blood cells (WBC) | Baseline and at 1st, 2nd, and third month | White blood cells (x10\^3/ul) |
| Evaluate biochemical data change-Red blood cells (RBC) | Baseline and at 1st, 2nd, and third month | Red blood cells (x10\^6/ul) |
| Evaluate biochemical data change-Hemoglobin (Hb) | Baseline and at 1st, 2nd, and third month | Hemoglobin (g/dl) |
| Evaluate biochemical data change-Hematocrit (Hct) | Baseline and at 1st, 2nd, and third month | Hematocrit (%) |
| Evaluate biochemical data change-Platelet | Baseline and at 1st, 2nd, and third month | Platelet (x10\^3/ul) |
| Evaluate biochemical data change-Mean corpuscular volume (MCV) | Baseline and at 1st, 2nd, and third month | Mean corpuscular volume (fl) |
| Evaluate biochemical data change-Mean corpuscular hemoglobin (MCH) | Baseline and at 1st, 2nd, and third month | Mean corpuscular hemoglobin (pg) |
| Evaluate anthropometric measurements change-Body weight | Baseline and at 0.5th, 1st, 1.5th, 2nd, 2.5th, and third month | Weight in kilograms |
| Evaluate biochemical data change-Neutrophil band | Baseline and at 1st, 2nd, and third month | Neutrophils (%), Lymphocyte (%), Monocyte (%), Eosinophil (%), and Basophil (%) |
| Evaluate biochemical data change-renal function | Baseline and at 1st, 2nd, and third month | Blood urea nitrogen and Creatinine (mg/dl) |
| Evaluate biochemical data change-Albumin (Alb) | Baseline and at 1st, 2nd, and third month | Albumin (g/dl) |
| Evaluate biochemical data change-liver function | Baseline and at 1st, 2nd, and third month | Aspartate aminotransferase and Alanine aminotransferase (U/l) |
| Evaluate biochemical data change-lipid profile | Baseline and third month | Triglyceride, Total cholesterol, Low-density lipoprotein cholesterol, High-density lipoprotein cholesterol (mg/dl) |
| Evaluate food intake change (energy) | Baseline and at 0.5th, 1st, 1.5th, 2nd, 2.5th, and third month | Use 24-hour dietary recall to evaluate the nutrition intake (energy in calories) |
| Evaluate food intake change (protein) | Baseline and at 0.5th, 1st, 1.5th, 2nd, 2.5th, and third month | Use 24-hour dietary recall to evaluate the nutrition intake (protein in grams) |
| Evaluate quality of life indicators change | Baseline and at 0.5th, 1st, 1.5th, 2nd, 2.5th, and third month | Scores on the Quality of Life Scale (European Organization for Research and Treatment of Cancer quality of life questionnaires core 30, EORTC QLQ-C30) |
| Evaluate biochemical data change-Mean corpuscular hemoglobin concentration (MCHC) | Baseline and at 1st, 2nd, and third month | Mean corpuscular hemoglobin concentration (g/dl) |
Countries
Taiwan
Outcome results
None listed