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

Malnutrition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05030090
• Other study ID #: N202105003
• Status: Completed
• Phase: N/A
• Start date: June 25, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: June 2021
• Source: Taipei Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: December 31, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer of Colon
• Cancer of Liver
• Colonic Neoplasms
• Colorectal Neoplasms
• Liver Neoplasms
• Malnutrition
• Nutrition Aspect of Cancer

Intervention

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).

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 ß-glucan and gamma-aminobutyric acid) and nutritional products and powdered supplement 2 (contains water-soluble dietary fiber and probiotics).

Locations

Country	Name	City	State
Taiwan	Taipei Medical University	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
Taipei Medical University	Taipei Medical University WanFang Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Evaluate anthropometric measurements change-Body weight	Weight in kilograms	Baseline and at 0.5th, 1st, 1.5th, 2nd, 2.5th, and third month
Secondary	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
Secondary	Evaluate biochemical data change-White blood cells (WBC)	White blood cells (x10^3/ul)	Baseline and at 1st, 2nd, and third month
Secondary	Evaluate biochemical data change-Red blood cells (RBC)	Red blood cells (x10^6/ul)	Baseline and at 1st, 2nd, and third month
Secondary	Evaluate biochemical data change-Hemoglobin (Hb)	Hemoglobin (g/dl)	Baseline and at 1st, 2nd, and third month
Secondary	Evaluate biochemical data change-Hematocrit (Hct)	Hematocrit (%)	Baseline and at 1st, 2nd, and third month
Secondary	Evaluate biochemical data change-Platelet	Platelet (x10^3/ul)	Baseline and at 1st, 2nd, and third month
Secondary	Evaluate biochemical data change-Mean corpuscular volume (MCV)	Mean corpuscular volume (fl)	Baseline and at 1st, 2nd, and third month
Secondary	Evaluate biochemical data change-Mean corpuscular hemoglobin (MCH)	Mean corpuscular hemoglobin (pg)	Baseline and at 1st, 2nd, and third month
Secondary	Evaluate biochemical data change-Mean corpuscular hemoglobin concentration (MCHC)	Mean corpuscular hemoglobin concentration (g/dl)	Baseline and at 1st, 2nd, and third month
Secondary	Evaluate biochemical data change-Neutrophil band	Neutrophils (%), Lymphocyte (%), Monocyte (%), Eosinophil (%), and Basophil (%)	Baseline and at 1st, 2nd, and third month
Secondary	Evaluate biochemical data change-renal function	Blood urea nitrogen and Creatinine (mg/dl)	Baseline and at 1st, 2nd, and third month
Secondary	Evaluate biochemical data change-Albumin (Alb)	Albumin (g/dl)	Baseline and at 1st, 2nd, and third month
Secondary	Evaluate biochemical data change-liver function	Aspartate aminotransferase and Alanine aminotransferase (U/l)	Baseline and at 1st, 2nd, and third month
Secondary	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
Secondary	Evaluate biochemical data change-lipid profile	Triglyceride, Total cholesterol, Low-density lipoprotein cholesterol, High-density lipoprotein cholesterol (mg/dl)	Baseline and third month
Secondary	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
Secondary	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
Secondary	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