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

Sponsor

Taipei Medical University (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05030090

Collaborator

Taipei Medical University WanFang Hospital (Other)

Enrollment

Location

Arms

12.2

Anticipated Duration (Months)

7.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Malnutrition Cancer of Colon Cancer of Liver Nutrition Aspect of Cancer	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	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 25, 2021

Anticipated Primary Completion Date :

Mar 31, 2022

Anticipated Study Completion Date :

Jun 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Control group 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 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.
Experimental: Nutrition care plan group A 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 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 Supplement: Nutritional 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).
Experimental: Nutrition care plan group B 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 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. Combination Product: Nutritional 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).

Arm

Intervention/Treatment

Active Comparator: Control group

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

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.

Experimental: Nutrition care plan group A

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

Dietary Supplement: Nutritional consultant + High-calorie, high-protein liquid nutrition supplement

Experimental: Nutrition care plan group B

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

Combination Product: Nutritional 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).

Outcome Measures

Primary Outcome Measures

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.
Evaluate nutritional status indicators change [Baseline and at 1st month]
Improvement of nutritional status indicators: Abridged Patient-Generated Subjective Global Assessment (aPG-SGA) assessment scores.
Evaluate nutritional status indicators change [Baseline and at 1.5th month]
Improvement of nutritional status indicators: Abridged Patient-Generated Subjective Global Assessment (aPG-SGA) assessment scores.
Evaluate nutritional status indicators change [Baseline and at 2nd month]
Improvement of nutritional status indicators: Abridged Patient-Generated Subjective Global Assessment (aPG-SGA) assessment scores.
Evaluate nutritional status indicators change [Baseline and at 2.5th month]
Improvement of nutritional status indicators: Abridged Patient-Generated Subjective Global Assessment (aPG-SGA) assessment scores.
Evaluate nutritional status indicators change [Baseline and at third month]
Improvement of nutritional status indicators: Abridged Patient-Generated Subjective Global Assessment (aPG-SGA) assessment scores.

Secondary Outcome Measures

Evaluate anthropometric measurements change-Body weight [Baseline and at 0.5th, 1st, 1.5th, 2nd, 2.5th, and third month]
Weight in kilograms
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 biochemical data change-Mean corpuscular hemoglobin concentration (MCHC) [Baseline and at 1st, 2nd, and third month]
Mean corpuscular hemoglobin concentration (g/dl)
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-renal function [Baseline and at 1st, 2nd, and third month]
estimated Glomerular filtration rate (eGFR) (mL/min/1.73 m^2)
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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