Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05030090
Other study ID # N202105003
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 25, 2021
Est. completion date December 31, 2022

Study information

Verified date June 2021
Source Taipei Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 66
Est. completion date December 31, 2022
Est. primary completion date September 30, 2022
Accepts healthy volunteers No
Gender All
Age group 20 Years to 70 Years
Eligibility 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 Design


Intervention

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).
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 ß-glucan and gamma-aminobutyric acid) and nutritional products and powdered supplement 2 (contains water-soluble dietary fiber and probiotics).

Locations

Country Name City State
Taiwan Taipei Medical University Taipei

Sponsors (2)

Lead Sponsor Collaborator
Taipei Medical University Taipei Medical University WanFang Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluate nutritional status indicators change Improvement of nutritional status indicators: Abridged Patient-Generated Subjective Global Assessment (aPG-SGA) assessment scores. Baseline and at 0.5th month
Primary Evaluate nutritional status indicators change Improvement of nutritional status indicators: Abridged Patient-Generated Subjective Global Assessment (aPG-SGA) assessment scores. Baseline and at 1st month
Primary Evaluate nutritional status indicators change Improvement of nutritional status indicators: Abridged Patient-Generated Subjective Global Assessment (aPG-SGA) assessment scores. Baseline and at 1.5th month
Primary Evaluate nutritional status indicators change Improvement of nutritional status indicators: Abridged Patient-Generated Subjective Global Assessment (aPG-SGA) assessment scores. Baseline and at 2nd month
Primary Evaluate nutritional status indicators change Improvement of nutritional status indicators: Abridged Patient-Generated Subjective Global Assessment (aPG-SGA) assessment scores. Baseline and at 2.5th month
Primary Evaluate nutritional status indicators change Improvement of nutritional status indicators: Abridged Patient-Generated Subjective Global Assessment (aPG-SGA) assessment scores. Baseline and at third month
Secondary Evaluate anthropometric measurements change-Body weight Weight in kilograms Baseline and at 0.5th, 1st, 1.5th, 2nd, 2.5th, and third month
Secondary Evaluate anthropometric measurements change-Body mass index(BMI) 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
Secondary Evaluate biochemical data change-White blood cells (WBC) White blood cells (x10^3/ul) Baseline and at 1st, 2nd, and third month
Secondary Evaluate biochemical data change-Red blood cells (RBC) Red blood cells (x10^6/ul) Baseline and at 1st, 2nd, and third month
Secondary Evaluate biochemical data change-Hemoglobin (Hb) Hemoglobin (g/dl) Baseline and at 1st, 2nd, and third month
Secondary Evaluate biochemical data change-Hematocrit (Hct) Hematocrit (%) Baseline and at 1st, 2nd, and third month
Secondary Evaluate biochemical data change-Platelet Platelet (x10^3/ul) Baseline and at 1st, 2nd, and third month
Secondary Evaluate biochemical data change-Mean corpuscular volume (MCV) Mean corpuscular volume (fl) Baseline and at 1st, 2nd, and third month
Secondary Evaluate biochemical data change-Mean corpuscular hemoglobin (MCH) Mean corpuscular hemoglobin (pg) Baseline and at 1st, 2nd, and third month
Secondary Evaluate biochemical data change-Mean corpuscular hemoglobin concentration (MCHC) Mean corpuscular hemoglobin concentration (g/dl) Baseline and at 1st, 2nd, and third month
Secondary Evaluate biochemical data change-Neutrophil band Neutrophils (%), Lymphocyte (%), Monocyte (%), Eosinophil (%), and Basophil (%) Baseline and at 1st, 2nd, and third month
Secondary Evaluate biochemical data change-renal function Blood urea nitrogen and Creatinine (mg/dl) Baseline and at 1st, 2nd, and third month
Secondary Evaluate biochemical data change-Albumin (Alb) Albumin (g/dl) Baseline and at 1st, 2nd, and third month
Secondary Evaluate biochemical data change-liver function Aspartate aminotransferase and Alanine aminotransferase (U/l) Baseline and at 1st, 2nd, and third month
Secondary Evaluate biochemical data change-renal function estimated Glomerular filtration rate (eGFR) (mL/min/1.73 m^2) Baseline and at 1st, 2nd, and third month
Secondary Evaluate biochemical data change-lipid profile Triglyceride, Total cholesterol, Low-density lipoprotein cholesterol, High-density lipoprotein cholesterol (mg/dl) Baseline and third month
Secondary Evaluate food intake change (energy) 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
Secondary Evaluate food intake change (protein) 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
Secondary 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) Baseline and at 0.5th, 1st, 1.5th, 2nd, 2.5th, and third month
See also
  Status Clinical Trial Phase
Completed NCT03268902 - Early Life Interventions for Childhood Growth and Development In Tanzania Phase 2/Phase 3
Active, not recruiting NCT04746664 - Effects of Nutrition Counselling on Old Age People's Nutritional Status and Quality of Life in Bahir Dar City, North West Ethiopia N/A
Completed NCT04608656 - Livestock for Health Project N/A
Completed NCT06009198 - Nutritional, and WASH Related Education Intervention to Address Malnutrition of Early Adolescents in Pakistan N/A
Recruiting NCT05417672 - Assessment of Relationship Between Preoperative Nutritional Status and Perioperative/Postoperative Conditions in Patients With Lung Cancer Scheduled for Lobectomy
Recruiting NCT05257980 - Evaluation of Four New Ready to Drink Oral Nutritional Supplements: Adult ONS Trial N/A
Completed NCT05015647 - Low Protein Diet in CKD Patients at Risk of Malnutrition N/A
Completed NCT03628196 - A Nutrition-Focused QIP in Outpatient Clinics
Enrolling by invitation NCT04675229 - Extending the Validation of SCREEN to Persons Living With Dementia or in Retirement Homes
Recruiting NCT04627376 - Multimodal Program for Cancer Related Cachexia Prevention N/A
Not yet recruiting NCT05860556 - Sustainable Eating Pattern to Limit Malnutrition in Older Adults
Not yet recruiting NCT06047054 - Incidence Rate and Risk Factors of Malnutrition in ICU
Not yet recruiting NCT04183075 - Impact of a Nutritional Supplement on the Recovery of the Nutritional Status of Patients With Spontaneous Hip Fracture N/A
Not yet recruiting NCT04398836 - Preoperative Nutrition for Crohn's Disease Patients Phase 3
Not yet recruiting NCT03150927 - Clinical Study of Novel Probiotic Microbial Compositeā„¢ to Treat Undernourished Young Children N/A
Recruiting NCT03408067 - Evaluation of the Efficacy of Nutritional Risk Screening Tests, NRS 2002 and SGA, to Identifying Malnourished Patients N/A
Recruiting NCT02833740 - Comparing Performance of Simplified Mid-Upper Arm Circumference Devices ("Click-MUACs") to Detect Acute Malnutrition N/A
Completed NCT02938247 - Tolerance and Compliance of a High Caloric, High Protein Oral Nutritional Supplement - Scheduled Intake N/A
Completed NCT02938234 - Tolerance and Compliance of a High Caloric, High Protein Oral Nutritional Supplement - Free Intake N/A
Completed NCT02800616 - The Healthy Elementary School of the Future N/A