MalnutritionNCT05030090
Integrative Nutrition Care Plan for the Patient With Liver and Colorectal Cancer
A study testing Nutritional consultant, Nutritional consultant + High-calorie, high-protein liquid nutrition supplement and Nutritional consultant + Liquid supplement + Powdered supplement 1 and 2 in people with Malnutrition and Cancer of Colon, run by Taipei Medical University at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Malnutrition, Cancer of Colon, Cancer of Liver
- What is being tested?
- Nutritional consultant, Nutritional consultant + High-calorie, high-protein liquid nutrition supplement and Nutritional consultant + Liquid supplement + Powdered supplement 1 and 2
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTaiwan
- Study dates
- 25 Jun 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Nutritional consultant, Nutritional consultant + High-calorie, high-protein liquid nutrition supplement, Nutritional consultant + Liquid supplement + Powdered supplement 1 and 2
- Keywords
- Nutrition care of cancer, Liver cancer, Colorectal cancer, Remote consultation, Nutrition supplement
- Medical subject headings
- Malnutrition, Colonic Neoplasms, Liver Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional consultantBehavioural
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 supplementDietary 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 2Combination 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).
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | 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. Receives: Behavioral: Nutritional consultant |
| Nutrition care plan group A | Experimental | 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. Receives: Behavioral: Nutritional consultant; Dietary Supplement: Nutritional consultant + High-calorie, high-protein liquid nutrition supplement |
| Nutrition care plan group B | Experimental | 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. Receives: Behavioral: Nutritional consultant; Combination Product: Nutritional consultant + Liquid supplement + Powdered supplement 1 and 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate nutritional status indicators change
Improvement of nutritional status indicators: Abridged Patient-Generated Subjective Global Assessment (aPG-SGA) assessment scores.
Measured: Baseline and at 0.5th month
Evaluate nutritional status indicators change
Improvement of nutritional status indicators: Abridged Patient-Generated Subjective Global Assessment (aPG-SGA) assessment scores.
Measured: Baseline and at 1st month
Evaluate nutritional status indicators change
Improvement of nutritional status indicators: Abridged Patient-Generated Subjective Global Assessment (aPG-SGA) assessment scores.
Measured: Baseline and at 1.5th month
Evaluate nutritional status indicators change
Improvement of nutritional status indicators: Abridged Patient-Generated Subjective Global Assessment (aPG-SGA) assessment scores.
Measured: Baseline and at 2nd month
Evaluate nutritional status indicators change
Improvement of nutritional status indicators: Abridged Patient-Generated Subjective Global Assessment (aPG-SGA) assessment scores.
Measured: Baseline and at 2.5th month
Evaluate nutritional status indicators change
Improvement of nutritional status indicators: Abridged Patient-Generated Subjective Global Assessment (aPG-SGA) assessment scores.
Measured: Baseline and at third month
Secondary outcomes (19)
Evaluate anthropometric measurements change-Body weight
Weight in kilograms
Measured: Baseline and at 0.5th, 1st, 1.5th, 2nd, 2.5th, and third month
Evaluate anthropometric measurements change-Body mass index(BMI)
Weight and height will be combined to report BMI in kg/m^2
Measured: Baseline and at 0.5th, 1st, 1.5th, 2nd, 2.5th, and third month
Evaluate biochemical data change-White blood cells (WBC)
White blood cells (x10^3/ul)
Measured: Baseline and at 1st, 2nd, and third month
Evaluate biochemical data change-Red blood cells (RBC)
Red blood cells (x10^6/ul)
Measured: Baseline and at 1st, 2nd, and third month
Evaluate biochemical data change-Hemoglobin (Hb)
Hemoglobin (g/dl)
Measured: Baseline and at 1st, 2nd, and third month
Evaluate biochemical data change-Hematocrit (Hct)
Hematocrit (%)
Measured: Baseline and at 1st, 2nd, and third month
Evaluate biochemical data change-Platelet
Platelet (x10^3/ul)
Measured: Baseline and at 1st, 2nd, and third month
Evaluate biochemical data change-Mean corpuscular volume (MCV)
Mean corpuscular volume (fl)
Measured: Baseline and at 1st, 2nd, and third month
Evaluate biochemical data change-Mean corpuscular hemoglobin (MCH)
Mean corpuscular hemoglobin (pg)
Measured: Baseline and at 1st, 2nd, and third month
Evaluate biochemical data change-Mean corpuscular hemoglobin concentration (MCHC)
Mean corpuscular hemoglobin concentration (g/dl)
Measured: Baseline and at 1st, 2nd, and third month
Evaluate biochemical data change-Neutrophil band
Neutrophils (%), Lymphocyte (%), Monocyte (%), Eosinophil (%), and Basophil (%)
Measured: Baseline and at 1st, 2nd, and third month
Evaluate biochemical data change-renal function
Blood urea nitrogen and Creatinine (mg/dl)
Measured: Baseline and at 1st, 2nd, and third month
Evaluate biochemical data change-Albumin (Alb)
Albumin (g/dl)
Measured: Baseline and at 1st, 2nd, and third month
Evaluate biochemical data change-liver function
Aspartate aminotransferase and Alanine aminotransferase (U/l)
Measured: Baseline and at 1st, 2nd, and third month
Evaluate biochemical data change-renal function
estimated Glomerular filtration rate (eGFR) (mL/min/1.73 m^2)
Measured: Baseline and at 1st, 2nd, and third month
Evaluate biochemical data change-lipid profile
Triglyceride, Total cholesterol, Low-density lipoprotein cholesterol, High-density lipoprotein cholesterol (mg/dl)
Measured: Baseline and third month
Evaluate food intake change (energy)
Use 24-hour dietary recall to evaluate the nutrition intake (energy in calories)
Measured: Baseline and at 0.5th, 1st, 1.5th, 2nd, 2.5th, and third month
Evaluate food intake change (protein)
Use 24-hour dietary recall to evaluate the nutrition intake (protein in grams)
Measured: Baseline and at 0.5th, 1st, 1.5th, 2nd, 2.5th, and third month
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)
Measured: Baseline and at 0.5th, 1st, 1.5th, 2nd, 2.5th, and third month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2021
- Study start25 Jun 2021
- Primary completion30 Sep 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Taipei Medical University WanFang Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05030090
- Sponsor's protocol ID
- N202105003
- Status last verified
- Jun 2021
- First submitted
- 25 Jun 2021
- Last updated
- 31 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrative Nutrition Care Plan for the Patient With Liver and Colorectal Cancer
- ClinicalTrials.gov ID
- NCT05030090
- Acronym / sponsor ID
- N202105003
- Keywords
- Nutrition care of cancer, Liver cancer, Colorectal cancer, Remote consultation, Nutrition supplement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Collaborators
- Taipei Medical University WanFang Hospital
- Study start
- 25 Jun 2021 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 1 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Behavioral: Nutritional consultant1. 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. |
| Nutrition care plan group A | Experimental | Behavioral: Nutritional consultant, Dietary Supplement: Nutritional consultant + High-calorie, high-protein liquid nutrition supplement1. 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. |
| Nutrition care plan group B | Experimental | Behavioral: Nutritional consultant, Combination Product: Nutritional consultant + Liquid supplement + Powdered supplement 1 and 21. 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. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritional consultantThe 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. | Behavioural | Control group, Nutrition care plan group A, Nutrition care plan group B |
| Nutritional consultant + High-calorie, high-protein liquid nutrition supplementAt 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). | Dietary supplement | Nutrition care plan group A |
| Nutritional consultant + Liquid supplement + Powdered supplement 1 and 2At 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). | Combination product | Nutrition care plan group B |
Primary outcome
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.
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.
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.
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.
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.
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.
19 secondary outcomes
Evaluate anthropometric measurements change-Body weight
Time frame: 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
Evaluate biochemical data change-White blood cells (WBC)
Time frame: 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
Evaluate biochemical data change-Hemoglobin (Hb)
Time frame: Baseline and at 1st, 2nd, and third month
Evaluate biochemical data change-Hematocrit (Hct)
Time frame: Baseline and at 1st, 2nd, and third month
Evaluate biochemical data change-Platelet
Time frame: 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
Evaluate biochemical data change-Mean corpuscular hemoglobin (MCH)
Time frame: 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
Evaluate biochemical data change-Neutrophil band
Time frame: Baseline and at 1st, 2nd, and third month
Evaluate biochemical data change-renal function
Time frame: Baseline and at 1st, 2nd, and third month
Evaluate biochemical data change-Albumin (Alb)
Time frame: Baseline and at 1st, 2nd, and third month
Evaluate biochemical data change-liver function
Time frame: Baseline and at 1st, 2nd, and third month
Evaluate biochemical data change-renal function
Time frame: Baseline and at 1st, 2nd, and third month
Evaluate biochemical data change-lipid profile
Time frame: 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
Evaluate food intake change (protein)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional consultant, Nutritional consultant + High-calorie, high-protein liquid nutrition supplement and Nutritional consultant + Liquid supplement + Powdered supplement 1 and 2 in people with Malnutrition and Cancer of Colon, run by Taipei Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate nutritional status indicators change (time frame: Baseline and at 0.5th month). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2023.