Clinical trial NCT05030090: Integrative Nutrition Care Plan for the Patient With Liver and Colorectal Cancer
Official title: Integrative Nutrition Care Plan for the Patient With Liver and Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition
Cancer of Colon
Cancer of Liver
Nutrition Aspect of Cancer
Keywords: Nutrition care of cancer
Liver cancer
Colorectal cancer
Remote consultation
Nutrition supplement
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
Collaborators: name: Taipei Medical University WanFang Hospital
First posted: 2021-09-01
Enrollment: 66
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Evaluate nutritional status indicators change
timeFrame: Baseline and at 0.5th month
measure: Evaluate nutritional status indicators change
timeFrame: Baseline and at 1st month
measure: Evaluate nutritional status indicators change
timeFrame: Baseline and at 1.5th month
measure: Evaluate nutritional status indicators change
timeFrame: Baseline and at 2nd month
measure: Evaluate nutritional status indicators change
timeFrame: Baseline and at 2.5th month
measure: Evaluate nutritional status indicators change
timeFrame: Baseline and at third month
Secondary outcomes:
measure: Evaluate anthropometric measurements change-Body weight
timeFrame: Baseline and at 0.5th, 1st, 1.5th, 2nd, 2.5th, and third month
measure: Evaluate anthropometric measurements change-Body mass index(BMI)
timeFrame: Baseline and at 0.5th, 1st, 1.5th, 2nd, 2.5th, and third month
measure: Evaluate biochemical data change-White blood cells (WBC)
timeFrame: Baseline and at 1st, 2nd, and third month
measure: Evaluate biochemical data change-Red blood cells (RBC)
timeFrame: Baseline and at 1st, 2nd, and third month
measure: Evaluate biochemical data change-Hemoglobin (Hb)
timeFrame: Baseline and at 1st, 2nd, and third month
measure: Evaluate biochemical data change-Hematocrit (Hct)
timeFrame: Baseline and at 1st, 2nd, and third month
measure: Evaluate biochemical data change-Platelet
timeFrame: Baseline and at 1st, 2nd, and third month
measure: Evaluate biochemical data change-Mean corpuscular volume (MCV)
timeFrame: Baseline and at 1st, 2nd, and third month
measure: Evaluate biochemical data change-Mean corpuscular hemoglobin (MCH)
timeFrame: Baseline and at 1st, 2nd, and third month
measure: Evaluate biochemical data change-Mean corpuscular hemoglobin concentration (MCHC)
timeFrame: Baseline and at 1st, 2nd, and third month
measure: Evaluate biochemical data change-Neutrophil band
timeFrame: Baseline and at 1st, 2nd, and third month
measure: Evaluate biochemical data change-renal function
timeFrame: Baseline and at 1st, 2nd, and third month
measure: Evaluate biochemical data change-Albumin (Alb)
timeFrame: Baseline and at 1st, 2nd, and third month
measure: Evaluate biochemical data change-liver function
timeFrame: Baseline and at 1st, 2nd, and third month
measure: Evaluate biochemical data change-renal function
timeFrame: Baseline and at 1st, 2nd, and third month
measure: Evaluate biochemical data change-lipid profile
timeFrame: Baseline and third month
measure: Evaluate food intake change (energy)
timeFrame: Baseline and at 0.5th, 1st, 1.5th, 2nd, 2.5th, and third month
measure: Evaluate food intake change (protein)
timeFrame: Baseline and at 0.5th, 1st, 1.5th, 2nd, 2.5th, and third month
measure: Evaluate quality of life indicators change
timeFrame: Baseline and at 0.5th, 1st, 1.5th, 2nd, 2.5th, and third month
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University
Study officials:
References: