Back to resultsIntegrative Nutrition Care Plan for the Patient With Liver and Colorectal Cancer
Primary Purpose
Malnutrition, Cancer of Colon, Cancer of Liver
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Nutritional consultant
Nutritional consultant + High-calorie, high-protein liquid nutrition supplement
Nutritional consultant + Liquid supplement + Powdered supplement 1 and 2
Sponsored by
About this trial
This is an interventional treatment trial for Malnutrition focused on measuring Nutrition care of cancer, Liver cancer, Colorectal cancer, Remote consultation, Nutrition supplement
Eligibility Criteria
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
Sites / Locations
- Taipei Medical University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Control group
Nutrition care plan group A
Nutrition care plan group B
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
Evaluate nutritional status indicators change
Improvement of nutritional status indicators: Abridged Patient-Generated Subjective Global Assessment (aPG-SGA) assessment scores.
Evaluate nutritional status indicators change
Improvement of nutritional status indicators: Abridged Patient-Generated Subjective Global Assessment (aPG-SGA) assessment scores.
Evaluate nutritional status indicators change
Improvement of nutritional status indicators: Abridged Patient-Generated Subjective Global Assessment (aPG-SGA) assessment scores.
Evaluate nutritional status indicators change
Improvement of nutritional status indicators: Abridged Patient-Generated Subjective Global Assessment (aPG-SGA) assessment scores.
Evaluate nutritional status indicators change
Improvement of nutritional status indicators: Abridged Patient-Generated Subjective Global Assessment (aPG-SGA) assessment scores.
Evaluate nutritional status indicators change
Improvement of nutritional status indicators: Abridged Patient-Generated Subjective Global Assessment (aPG-SGA) assessment scores.
Secondary Outcome Measures
Evaluate anthropometric measurements change-Body weight
Weight in kilograms
Evaluate anthropometric measurements change-Body mass index(BMI)
Weight and height will be combined to report BMI in kg/m^2
Evaluate biochemical data change-White blood cells (WBC)
White blood cells (x10^3/ul)
Evaluate biochemical data change-Red blood cells (RBC)
Red blood cells (x10^6/ul)
Evaluate biochemical data change-Hemoglobin (Hb)
Hemoglobin (g/dl)
Evaluate biochemical data change-Hematocrit (Hct)
Hematocrit (%)
Evaluate biochemical data change-Platelet
Platelet (x10^3/ul)
Evaluate biochemical data change-Mean corpuscular volume (MCV)
Mean corpuscular volume (fl)
Evaluate biochemical data change-Mean corpuscular hemoglobin (MCH)
Mean corpuscular hemoglobin (pg)
Evaluate biochemical data change-Mean corpuscular hemoglobin concentration (MCHC)
Mean corpuscular hemoglobin concentration (g/dl)
Evaluate biochemical data change-Neutrophil band
Neutrophils (%), Lymphocyte (%), Monocyte (%), Eosinophil (%), and Basophil (%)
Evaluate biochemical data change-renal function
Blood urea nitrogen and Creatinine (mg/dl)
Evaluate biochemical data change-Albumin (Alb)
Albumin (g/dl)
Evaluate biochemical data change-liver function
Aspartate aminotransferase and Alanine aminotransferase (U/l)
Evaluate biochemical data change-renal function
estimated Glomerular filtration rate (eGFR) (mL/min/1.73 m^2)
Evaluate biochemical data change-lipid profile
Triglyceride, Total cholesterol, Low-density lipoprotein cholesterol, High-density lipoprotein cholesterol (mg/dl)
Evaluate food intake change (energy)
Use 24-hour dietary recall to evaluate the nutrition intake (energy in calories)
Evaluate food intake change (protein)
Use 24-hour dietary recall to evaluate the nutrition intake (protein in grams)
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)
Full Information
NCT ID
NCT05030090
First Posted
June 25, 2021
Last Updated
May 28, 2023
Sponsor
Taipei Medical University
Collaborators
Taipei Medical University WanFang Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05030090
Brief Title
Integrative Nutrition Care Plan for the Patient With Liver and Colorectal Cancer
Official Title
Integrative Nutrition Care Plan for the Patient With Liver and Colorectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
June 25, 2021 (Actual)
Primary Completion Date
September 30, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Medical University
Collaborators
Taipei Medical University WanFang Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition, Cancer of Colon, Cancer of Liver, Nutrition Aspect of Cancer
Keywords
Nutrition care of cancer, Liver cancer, Colorectal cancer, Remote consultation, Nutrition supplement
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Nutrition care plan group A
Arm Type
Experimental
Arm Description
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.
Arm Title
Nutrition care plan group B
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Nutritional consultant
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Nutritional consultant + High-calorie, high-protein liquid nutrition supplement
Intervention Description
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).
Intervention Type
Combination Product
Intervention Name(s)
Nutritional consultant + Liquid supplement + Powdered supplement 1 and 2
Intervention Description
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).
Primary Outcome Measure Information:
Title
Evaluate nutritional status indicators change
Description
Improvement of nutritional status indicators: Abridged Patient-Generated Subjective Global Assessment (aPG-SGA) assessment scores.
Time Frame
Baseline and at 0.5th month
Title
Evaluate nutritional status indicators change
Description
Improvement of nutritional status indicators: Abridged Patient-Generated Subjective Global Assessment (aPG-SGA) assessment scores.
Time Frame
Baseline and at 1st month
Title
Evaluate nutritional status indicators change
Description
Improvement of nutritional status indicators: Abridged Patient-Generated Subjective Global Assessment (aPG-SGA) assessment scores.
Time Frame
Baseline and at 1.5th month
Title
Evaluate nutritional status indicators change
Description
Improvement of nutritional status indicators: Abridged Patient-Generated Subjective Global Assessment (aPG-SGA) assessment scores.
Time Frame
Baseline and at 2nd month
Title
Evaluate nutritional status indicators change
Description
Improvement of nutritional status indicators: Abridged Patient-Generated Subjective Global Assessment (aPG-SGA) assessment scores.
Time Frame
Baseline and at 2.5th month
Title
Evaluate nutritional status indicators change
Description
Improvement of nutritional status indicators: Abridged Patient-Generated Subjective Global Assessment (aPG-SGA) assessment scores.
Time Frame
Baseline and at third month
Secondary Outcome Measure Information:
Title
Evaluate anthropometric measurements change-Body weight
Description
Weight in kilograms
Time Frame
Baseline and at 0.5th, 1st, 1.5th, 2nd, 2.5th, and third month
Title
Evaluate anthropometric measurements change-Body mass index(BMI)
Description
Weight and height will be combined to report BMI in kg/m^2
Time Frame
Baseline and at 0.5th, 1st, 1.5th, 2nd, 2.5th, and third month
Title
Evaluate biochemical data change-White blood cells (WBC)
Description
White blood cells (x10^3/ul)
Time Frame
Baseline and at 1st, 2nd, and third month
Title
Evaluate biochemical data change-Red blood cells (RBC)
Description
Red blood cells (x10^6/ul)
Time Frame
Baseline and at 1st, 2nd, and third month
Title
Evaluate biochemical data change-Hemoglobin (Hb)
Description
Hemoglobin (g/dl)
Time Frame
Baseline and at 1st, 2nd, and third month
Title
Evaluate biochemical data change-Hematocrit (Hct)
Description
Hematocrit (%)
Time Frame
Baseline and at 1st, 2nd, and third month
Title
Evaluate biochemical data change-Platelet
Description
Platelet (x10^3/ul)
Time Frame
Baseline and at 1st, 2nd, and third month
Title
Evaluate biochemical data change-Mean corpuscular volume (MCV)
Description
Mean corpuscular volume (fl)
Time Frame
Baseline and at 1st, 2nd, and third month
Title
Evaluate biochemical data change-Mean corpuscular hemoglobin (MCH)
Description
Mean corpuscular hemoglobin (pg)
Time Frame
Baseline and at 1st, 2nd, and third month
Title
Evaluate biochemical data change-Mean corpuscular hemoglobin concentration (MCHC)
Description
Mean corpuscular hemoglobin concentration (g/dl)
Time Frame
Baseline and at 1st, 2nd, and third month
Title
Evaluate biochemical data change-Neutrophil band
Description
Neutrophils (%), Lymphocyte (%), Monocyte (%), Eosinophil (%), and Basophil (%)
Time Frame
Baseline and at 1st, 2nd, and third month
Title
Evaluate biochemical data change-renal function
Description
Blood urea nitrogen and Creatinine (mg/dl)
Time Frame
Baseline and at 1st, 2nd, and third month
Title
Evaluate biochemical data change-Albumin (Alb)
Description
Albumin (g/dl)
Time Frame
Baseline and at 1st, 2nd, and third month
Title
Evaluate biochemical data change-liver function
Description
Aspartate aminotransferase and Alanine aminotransferase (U/l)
Time Frame
Baseline and at 1st, 2nd, and third month
Title
Evaluate biochemical data change-renal function
Description
estimated Glomerular filtration rate (eGFR) (mL/min/1.73 m^2)
Time Frame
Baseline and at 1st, 2nd, and third month
Title
Evaluate biochemical data change-lipid profile
Description
Triglyceride, Total cholesterol, Low-density lipoprotein cholesterol, High-density lipoprotein cholesterol (mg/dl)
Time Frame
Baseline and third month
Title
Evaluate food intake change (energy)
Description
Use 24-hour dietary recall to evaluate the nutrition intake (energy in calories)
Time Frame
Baseline and at 0.5th, 1st, 1.5th, 2nd, 2.5th, and third month
Title
Evaluate food intake change (protein)
Description
Use 24-hour dietary recall to evaluate the nutrition intake (protein in grams)
Time Frame
Baseline and at 0.5th, 1st, 1.5th, 2nd, 2.5th, and third month
Title
Evaluate quality of life indicators change
Description
Scores on the Quality of Life Scale (European Organization for Research and Treatment of Cancer quality of life questionnaires core 30, EORTC QLQ-C30)
Time Frame
Baseline and at 0.5th, 1st, 1.5th, 2nd, 2.5th, and third month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Taipei Medical University
City
Taipei
ZIP/Postal Code
110
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Integrative Nutrition Care Plan for the Patient With Liver and Colorectal Cancer
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