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

May 28, 2023 updated by: Taipei Medical University
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
66

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 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.
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
  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.
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
  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.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline and at 0.5th month
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.
Baseline and at 1st month
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.
Baseline and at 1.5th month
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.
Baseline and at 2nd month
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.
Baseline and at 2.5th month
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.
Baseline and at third month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Baseline and at 0.5th, 1st, 1.5th, 2nd, 2.5th, and third month
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
Baseline and at 0.5th, 1st, 1.5th, 2nd, 2.5th, and third month
Evaluate biochemical data change-White blood cells (WBC)
Time Frame: Baseline and at 1st, 2nd, and third month
White blood cells (x10^3/ul)
Baseline and at 1st, 2nd, and third month
Evaluate biochemical data change-Red blood cells (RBC)
Time Frame: Baseline and at 1st, 2nd, and third month
Red blood cells (x10^6/ul)
Baseline and at 1st, 2nd, and third month
Evaluate biochemical data change-Hemoglobin (Hb)
Time Frame: Baseline and at 1st, 2nd, and third month
Hemoglobin (g/dl)
Baseline and at 1st, 2nd, and third month
Evaluate biochemical data change-Hematocrit (Hct)
Time Frame: Baseline and at 1st, 2nd, and third month
Hematocrit (%)
Baseline and at 1st, 2nd, and third month
Evaluate biochemical data change-Platelet
Time Frame: Baseline and at 1st, 2nd, and third month
Platelet (x10^3/ul)
Baseline and at 1st, 2nd, and third month
Evaluate biochemical data change-Mean corpuscular volume (MCV)
Time Frame: Baseline and at 1st, 2nd, and third month
Mean corpuscular volume (fl)
Baseline and at 1st, 2nd, and third month
Evaluate biochemical data change-Mean corpuscular hemoglobin (MCH)
Time Frame: Baseline and at 1st, 2nd, and third month
Mean corpuscular hemoglobin (pg)
Baseline and at 1st, 2nd, and third month
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)
Baseline and at 1st, 2nd, and third month
Evaluate biochemical data change-Neutrophil band
Time Frame: Baseline and at 1st, 2nd, and third month
Neutrophils (%), Lymphocyte (%), Monocyte (%), Eosinophil (%), and Basophil (%)
Baseline and at 1st, 2nd, and third month
Evaluate biochemical data change-renal function
Time Frame: Baseline and at 1st, 2nd, and third month
Blood urea nitrogen and Creatinine (mg/dl)
Baseline and at 1st, 2nd, and third month
Evaluate biochemical data change-Albumin (Alb)
Time Frame: Baseline and at 1st, 2nd, and third month
Albumin (g/dl)
Baseline and at 1st, 2nd, and third month
Evaluate biochemical data change-liver function
Time Frame: Baseline and at 1st, 2nd, and third month
Aspartate aminotransferase and Alanine aminotransferase (U/l)
Baseline and at 1st, 2nd, and third month
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)
Baseline and at 1st, 2nd, and third month
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)
Baseline and third month
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)
Baseline and at 0.5th, 1st, 1.5th, 2nd, 2.5th, and third month
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)
Baseline and at 0.5th, 1st, 1.5th, 2nd, 2.5th, and third month
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)
Baseline and at 0.5th, 1st, 1.5th, 2nd, 2.5th, and third month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Taipei Medical University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Taipei Medical University WanFang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 25, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 25, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 1, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 31, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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