search
Back to results

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
Hanoi Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gastric Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    August 14, 2020
    Last Updated
    August 17, 2020
    Sponsor
    Hanoi Medical University
    Collaborators
    Ministry of Health of Vietnam, Hanoi Medical University Hospital
    search

    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

    We'll reach out to this number within 24 hrs