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

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.

Study Overview

• Status: Completed
• Conditions: Malnutrition; Cancer of Liver; Nutrition Aspect of Cancer; Cancer of Colon
• Intervention / Treatment: 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

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 Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 110
    • Taipei Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / 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).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Taipei Medical University
• Collaborators: Taipei Medical University WanFang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2021
• Primary Completion (Actual): September 30, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: June 25, 2021
• First Submitted That Met QC Criteria: August 30, 2021
• First Posted (Actual): September 1, 2021

Study Record Updates

• Last Update Posted (Actual): May 31, 2023
• Last Update Submitted That Met QC Criteria: May 28, 2023
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Colorectal cancer; Liver cancer; Remote consultation; Nutrition supplement; Nutrition care of cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Liver Diseases; Nutrition Disorders; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Malnutrition; Liver Neoplasms; Colonic Neoplasms
• Other Study ID Numbers: N202105003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No