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

Not Applicable

Completed

• Conditions: Cancer of Colon; Cancer of Liver; Nutrition Aspect of Cancer; Malnutrition
• Interventions: Behavioral: Nutritional consultant; Combination Product: Nutritional consultant + Liquid supplement + Powdered supplement 1 and 2; Dietary Supplement: Nutritional consultant + High-calorie, high-protein liquid nutrition supplement

• Registration Number: NCT05030090
• Lead Sponsor: Taipei Medical University

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.

Study Timeline

• Status Verified: 2021-06
• Study Start: 2021-06-25
• Study First Submitted: 2021-06-25
• Study First Submitted QC: 2021-08-30
• Study First Posted: 2021-09-01
• Primary Completion: 2022-09-30
• Study Completion: 2022-12-31
• Last Update Submitted: 2023-05-28
• Last Update Posted: 2023-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Nutritional consultant	1. Consulted by the dietitian using communication software (Line) or telephone. 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. 3. The nutrition care plan period will be three months.
Nutrition care plan group B	Nutritional consultant	1. Consulted by the dietitian using communication software (Line) or telephone. 2. 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 3. At 0.5, 1, 1.5, 2, 2.5, and 3 months will track the biochemical data, assess nutritional status and quality of life. 4. The nutrition care plan period will be three months.
Nutrition care plan group B	Nutritional consultant + Liquid supplement + Powdered supplement 1 and 2	1. Consulted by the dietitian using communication software (Line) or telephone. 2. 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 3. At 0.5, 1, 1.5, 2, 2.5, and 3 months will track the biochemical data, assess nutritional status and quality of life. 4. The nutrition care plan period will be three months.
Nutrition care plan group A	Nutritional consultant	1. Consulted by the dietitian using communication software (Line) or telephone. 2. Implement a daily diet with a concentrated high-calorie and high-protein liquid supplement 3. 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.
Nutrition care plan group A	Nutritional consultant + High-calorie, high-protein liquid nutrition supplement	1. Consulted by the dietitian using communication software (Line) or telephone. 2. Implement a daily diet with a concentrated high-calorie and high-protein liquid supplement 3. 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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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-Mean corpuscular volume (MCV)	Baseline and at 1st, 2nd, and third month	Mean corpuscular volume (fl)
Evaluate biochemical data change-Neutrophil band	Baseline and at 1st, 2nd, and third month	Neutrophils (%), Lymphocyte (%), Monocyte (%), Eosinophil (%), and Basophil (%)
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 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-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-Hematocrit (Hct)	Baseline and at 1st, 2nd, and third month	Hematocrit (%)
Evaluate biochemical data change-Albumin (Alb)	Baseline and at 1st, 2nd, and third month	Albumin (g/dl)
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-Hemoglobin (Hb)	Baseline and at 1st, 2nd, and third month	Hemoglobin (g/dl)
Evaluate biochemical data change-Platelet	Baseline and at 1st, 2nd, and third month	Platelet (x10\^3/ul)
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 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-lipid profile	Baseline and third month	Triglyceride, Total cholesterol, Low-density lipoprotein cholesterol, High-density lipoprotein cholesterol (mg/dl)

Trial Locations

Locations (1)

Taipei Medical University; 🇨🇳 Taipei, Taiwan