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Completed

NCT Number: NCT05030090

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.

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Key information

Conditions

Malnutrition Cancer of Colon Cancer of Liver Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Site Nutrition Aspect of Cancer Nutrition Disorders Nutritional and Metabolic Diseases Rectal Diseases

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taipei Medical University

Taipei, 110, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with liver cancer or colorectal cancer stage I to III
  • Not suffering from other carcinomas in situ at the same time
  • Will undergo surgery or non-surgical cancer treatment
  • Can move, read and answer questions by itself
  • At least one social support (family or friend) to assist and support the patient to complete the trial
  • According to the aPG-SGA, the assessment score is between 4 ~ 9
  • 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.
  • Able to adjust diet or take nutrition and supplements daily with the guidance of a nutritionist
  • 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

  • Perform organ transplantation or palliative care
  • Hepatic encephalopathy
  • History of cardiovascular and cerebrovascular diseases
  • Severe organ failure of the heart, breathing, or kidneys
  • History of digestive tract inflammation or ulcer
  • Severe mental illness
  • An active infectious diseases
  • Those who can only use intravenous nutrition and cannot use enteral nutrition
  • People who are allergic to product ingredients (milk, soy, or mango and their products)
  • Unwilling to cooperate with dietitians to make dietary adjustments or supplement nutrition and supplements
  • Unwilling to actively treat cancer

Treatment and study plan

Nutritional consultant

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

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).

Nutritional consultant + Liquid supplement + Powdered supplement 1 and 2

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).

Primary outcomes

  1. Evaluate nutritional status indicators change

    Time frame: Baseline and at 0.5th month

    Improvement of nutritional status indicators: Abridged Patient-Generated Subjective Global Assessment (aPG-SGA) assessment scores.

  2. Evaluate nutritional status indicators change

    Time frame: Baseline and at 1st month

    Improvement of nutritional status indicators: Abridged Patient-Generated Subjective Global Assessment (aPG-SGA) assessment scores.

  3. Evaluate nutritional status indicators change

    Time frame: Baseline and at 1.5th month

    Improvement of nutritional status indicators: Abridged Patient-Generated Subjective Global Assessment (aPG-SGA) assessment scores.

  4. Evaluate nutritional status indicators change

    Time frame: Baseline and at 2nd month

    Improvement of nutritional status indicators: Abridged Patient-Generated Subjective Global Assessment (aPG-SGA) assessment scores.

  5. Evaluate nutritional status indicators change

    Time frame: Baseline and at 2.5th month

    Improvement of nutritional status indicators: Abridged Patient-Generated Subjective Global Assessment (aPG-SGA) assessment scores.

  6. Evaluate nutritional status indicators change

    Time frame: Baseline and at third month

    Improvement of nutritional status indicators: Abridged Patient-Generated Subjective Global Assessment (aPG-SGA) assessment scores.

Secondary outcomes

  1. Evaluate anthropometric measurements change-Body weight

    Time frame: Baseline and at 0.5th, 1st, 1.5th, 2nd, 2.5th, and third month

    Weight in kilograms

  2. Evaluate anthropometric measurements change-Body mass index(BMI)

    Time frame: 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

  3. Evaluate biochemical data change-White blood cells (WBC)

    Time frame: Baseline and at 1st, 2nd, and third month

    White blood cells (x10^3/ul)

  4. Evaluate biochemical data change-Red blood cells (RBC)

    Time frame: Baseline and at 1st, 2nd, and third month

    Red blood cells (x10^6/ul)

  5. Evaluate biochemical data change-Hemoglobin (Hb)

    Time frame: Baseline and at 1st, 2nd, and third month

    Hemoglobin (g/dl)

  6. Evaluate biochemical data change-Hematocrit (Hct)

    Time frame: Baseline and at 1st, 2nd, and third month

    Hematocrit (%)

  7. Evaluate biochemical data change-Platelet

    Time frame: Baseline and at 1st, 2nd, and third month

    Platelet (x10^3/ul)

  8. Evaluate biochemical data change-Mean corpuscular volume (MCV)

    Time frame: Baseline and at 1st, 2nd, and third month

    Mean corpuscular volume (fl)

  9. Evaluate biochemical data change-Mean corpuscular hemoglobin (MCH)

    Time frame: Baseline and at 1st, 2nd, and third month

    Mean corpuscular hemoglobin (pg)

  10. Evaluate biochemical data change-Mean corpuscular hemoglobin concentration (MCHC)

    Time frame: Baseline and at 1st, 2nd, and third month

    Mean corpuscular hemoglobin concentration (g/dl)

  11. Evaluate biochemical data change-Neutrophil band

    Time frame: Baseline and at 1st, 2nd, and third month

    Neutrophils (%), Lymphocyte (%), Monocyte (%), Eosinophil (%), and Basophil (%)

  12. Evaluate biochemical data change-renal function

    Time frame: Baseline and at 1st, 2nd, and third month

    Blood urea nitrogen and Creatinine (mg/dl)

  13. Evaluate biochemical data change-Albumin (Alb)

    Time frame: Baseline and at 1st, 2nd, and third month

    Albumin (g/dl)

  14. Evaluate biochemical data change-liver function

    Time frame: Baseline and at 1st, 2nd, and third month

    Aspartate aminotransferase and Alanine aminotransferase (U/l)

  15. Evaluate biochemical data change-renal function

    Time frame: Baseline and at 1st, 2nd, and third month

    estimated Glomerular filtration rate (eGFR) (mL/min/1.73 m^2)

  16. Evaluate biochemical data change-lipid profile

    Time frame: Baseline and third month

    Triglyceride, Total cholesterol, Low-density lipoprotein cholesterol, High-density lipoprotein cholesterol (mg/dl)

  17. Evaluate food intake change (energy)

    Time frame: 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)

  18. Evaluate food intake change (protein)

    Time frame: 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)

  19. Evaluate quality of life indicators change

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Taipei Medical University

Other

Collaborators

  • Taipei Medical University WanFang Hospital

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 1, 2021
Registry last updated
May 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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