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Clinical Trials/NCT04517708
NCT04517708
Completed
N/A

Effectiveness of Nutritional Interventions for Cancer Patients Undergoing Chemotherapy

Hanoi Medical University0 sites120 target enrollmentJanuary 15, 2016

Overview

Phase
N/A
Intervention
Not specified
Conditions
Gastric Cancer
Sponsor
Hanoi Medical University
Enrollment
120
Primary Endpoint
Change of quality of life after 8 weeks: European Organisation for Research and Treatment of Cancer (EORTC) version 3.0
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 15, 2016
End Date
December 15, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Hanoi Medical University
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Change of quality of life after 8 weeks: European Organisation for Research and Treatment of Cancer (EORTC) version 3.0

Time Frame: Baseline and 8 weeks

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.

Change of nutritional status after 8 weeks

Time Frame: Baseline and 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)

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