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

NCT ID: NCT05030090

Last Updated: 2023-05-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-25
• Study Completion Date: 2022-12-31

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.

Conditions

Malnutrition; Cancer of Colon; Cancer of Liver; Nutrition Aspect of Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control group

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.

Group Type: ACTIVE_COMPARATOR

Nutritional consultant

Intervention Type: BEHAVIORAL

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.

Nutrition care plan group A

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.

Group Type: EXPERIMENTAL

Nutritional consultant

Intervention Type: BEHAVIORAL

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.

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

Intervention Type: DIETARY_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).

Nutrition care plan group B

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.

Group Type: EXPERIMENTAL

Nutritional consultant

Intervention Type: BEHAVIORAL

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.

Nutritional consultant + Liquid supplement + Powdered supplement 1 and 2

Intervention Type: COMBINATION_PRODUCT

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).

Interventions

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.

Intervention Type: BEHAVIORAL

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).

Intervention Type: DIETARY_SUPPLEMENT

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).

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Medical University WanFang Hospital

OTHER

Sponsor Role: collaborator

Taipei Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Taipei Medical University

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

N202105003

Identifier Type: -

Identifier Source: org_study_id