Effectiveness of Nutritional Interventions for Cancer Patients Undergoing Chemotherapy
Primary Purpose
Gastric Cancer, Colon Cancer
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nutritional counseling
Sponsored by
About this trial
This is an interventional prevention trial for Gastric Cancer
Eligibility Criteria
Inclusion Criteria:
- aged 18 years old or above
- diagnosed with stomach or colon cancer;
- at the initial of receiving chemotherapy treatment;
- indicated for oral feeding;
- not having co-morbidities of chronic diseases such as kidney failure, heart failure, liver failure, diabetes;
- having ability to communicate with data collectors and both attending doctors and agreeing to involve in the study
Exclusion Criteria:
- treated by other methods such as radiation, endocrine, immunity;
- undergoing terminal palliative care;
- having contraindications to oral feeding/enteral nutrition
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group
Control group
Arm Description
Regarding the intervention group, patients were treated with the intervention regimen, which consisted of: Nutritional counseling Each patient was assigned a specific menu which were prepared by research members during the time of staying at the hospital. Before discharge, patients were instructed on preparing their diets at home with the recommended amount of energy and protein and given formula milk within two months.
Patients had diets based on their demands
Outcomes
Primary Outcome Measures
Change of nutritional status after 8 weeks
The Scored Patient-Generated Subjective Global Assessment (PG-SGA) was used as the preeminent interdisciplinary patient assessment among patients with oncology. This tool includes (1) four patient-generated historical components (Weight History, Food Intake, Symptoms, Activities and Function); (2) the professional part (Diagnosis, Metabolic stress, and Physical Exam); (3) the Global Assessment (A = well-nourished, B = moderately malnourished, C = severely malnourished); (4) the total score, and nutritional triage recommendations. Changes in anthropometric indicators were also reported (weight, MUAC, muscle mass)
Change of quality of life after 8 weeks: European Organisation for Research and Treatment of Cancer (EORTC) version 3.0
We utilized the European Organisation for Research and Treatment of Cancer (EORTC) version 3.0, which is an integrated and modular approach to holistically evaluate the QoL of patients with cancer.all dimensions of the tool will range from 0 to 100, in which a higher score presents a better level of functioning/the global health status or a worse level of symptoms.
Secondary Outcome Measures
Full Information
NCT ID
NCT04517708
First Posted
August 14, 2020
Last Updated
August 17, 2020
Sponsor
Hanoi Medical University
Collaborators
Ministry of Health of Vietnam, Hanoi Medical University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04517708
Brief Title
Effectiveness of Nutritional Interventions for Cancer Patients Undergoing Chemotherapy
Official Title
Effectiveness of Nutritional Interventions for Cancer Patients Undergoing Chemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
January 15, 2016 (Actual)
Primary Completion Date
June 1, 2019 (Actual)
Study Completion Date
December 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hanoi Medical University
Collaborators
Ministry of Health of Vietnam, Hanoi Medical University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study aims to estimate the effects of nutritional interventions on the improvement of nutritional status and quality of life (QoL) among gastrointestinal patients in Vietnam
Detailed Description
A quasi-experiment with intervention and control groups for pre- and post-intervention assessment was carried out at the Department of Oncology and Palliative Care - Medical University Hospital from 2016 to 2019. 60 gastrointestinal cancer patients were recruited in each group. At stage 1, we selected patients of the intervention group who met the inclusion criteria to receive nutritional counseling and diet at the hospital. At stage 2, we chose patients who were eligible but did not accept the nutritional counseling and diet at the hospital. Participants in both groups were paired together according to the following criteria: 1) Age group: <40 years old, 40-65 years old and >65 years old; 2) Gender: Male and female; 3) Types of cancer: stomach cancer and colon cancer; 4) Disease stages: stage 1-2 and stage 3-4.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer, Colon Cancer
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Regarding the intervention group, patients were treated with the intervention regimen, which consisted of:
Nutritional counseling
Each patient was assigned a specific menu which were prepared by research members during the time of staying at the hospital. Before discharge, patients were instructed on preparing their diets at home with the recommended amount of energy and protein and given formula milk within two months.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients had diets based on their demands
Intervention Type
Other
Intervention Name(s)
Nutritional counseling
Intervention Description
Each patient was assigned a specific menu which were prepared by research members during the time of staying at the hospital. Before discharge, patients were instructed on preparing their diets at home with the recommended amount of energy and protein and given formula milk within two months
Primary Outcome Measure Information:
Title
Change of nutritional status after 8 weeks
Description
The Scored Patient-Generated Subjective Global Assessment (PG-SGA) was used as the preeminent interdisciplinary patient assessment among patients with oncology. This tool includes (1) four patient-generated historical components (Weight History, Food Intake, Symptoms, Activities and Function); (2) the professional part (Diagnosis, Metabolic stress, and Physical Exam); (3) the Global Assessment (A = well-nourished, B = moderately malnourished, C = severely malnourished); (4) the total score, and nutritional triage recommendations. Changes in anthropometric indicators were also reported (weight, MUAC, muscle mass)
Time Frame
Baseline and 8 weeks
Title
Change of quality of life after 8 weeks: European Organisation for Research and Treatment of Cancer (EORTC) version 3.0
Description
We utilized the European Organisation for Research and Treatment of Cancer (EORTC) version 3.0, which is an integrated and modular approach to holistically evaluate the QoL of patients with cancer.all dimensions of the tool will range from 0 to 100, in which a higher score presents a better level of functioning/the global health status or a worse level of symptoms.
Time Frame
Baseline and 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
aged 18 years old or above
diagnosed with stomach or colon cancer;
at the initial of receiving chemotherapy treatment;
indicated for oral feeding;
not having co-morbidities of chronic diseases such as kidney failure, heart failure, liver failure, diabetes;
having ability to communicate with data collectors and both attending doctors and agreeing to involve in the study
Exclusion Criteria:
treated by other methods such as radiation, endocrine, immunity;
undergoing terminal palliative care;
having contraindications to oral feeding/enteral nutrition
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33550719
Citation
Nguyen LT, Dang AK, Duong PT, Phan HBT, Pham CTT, Nguyen ATL, Le HT. Nutrition intervention is beneficial to the quality of life of patients with gastrointestinal cancer undergoing chemotherapy in Vietnam. Cancer Med. 2021 Mar;10(5):1668-1680. doi: 10.1002/cam4.3766. Epub 2021 Feb 7.
Results Reference
derived
Learn more about this trial
Effectiveness of Nutritional Interventions for Cancer Patients Undergoing Chemotherapy
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