NCT05030090

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 25, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

June 25, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 1, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

May 31, 2023

Status Verified

June 1, 2021

Enrollment Period

1.3 years

First QC Date

June 25, 2021

Last Update Submit

May 28, 2023

Conditions

MalnutritionCancer of ColonCancer of LiverNutrition Aspect of Cancer

Keywords

Nutrition care of cancerLiver cancerColorectal cancerRemote consultationNutrition supplement

Outcome Measures

Primary Outcomes (6)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (19)

  • Evaluate anthropometric measurements change-Body weight

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

  • Evaluate anthropometric measurements change-Body mass index(BMI)

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

  • Evaluate biochemical data change-White blood cells (WBC)

    Baseline and at 1st, 2nd, and third month

  • Evaluate biochemical data change-Red blood cells (RBC)

    Baseline and at 1st, 2nd, and third month

  • Evaluate biochemical data change-Hemoglobin (Hb)

    Baseline and at 1st, 2nd, and third month

  • +14 more secondary outcomes

Study Arms (3)

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.

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.

Behavioral: Nutritional consultantDietary 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.

Behavioral: Nutritional consultantCombination Product: Nutritional consultant + Liquid supplement + Powdered supplement 1 and 2

Interventions

Nutritional consultantBEHAVIORAL

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.

Control groupNutrition care plan group ANutrition care plan group B
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).

Nutrition care plan group A
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).

Nutrition care plan group B

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Medical University

Taipei, 110, Taiwan

Location

MeSH Terms

Conditions

MalnutritionColonic NeoplasmsLiver NeoplasmsColorectal Neoplasms

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesLiver DiseasesRectal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2021

First Posted

September 1, 2021

Study Start

June 25, 2021

Primary Completion

September 30, 2022

Study Completion

December 31, 2022

Last Updated

May 31, 2023

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)