Effectiveness of Nutritional Interventions for Cancer Patients Undergoing Chemotherapy

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

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Key information

Conditions

Gastric Cancer Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

nutritional counseling

Other

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 outcomes

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)
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.

Sponsors and collaborators

Lead sponsor

Hanoi Medical University

Other

Collaborators

Ministry of Health, Vietnam

Registry information

Important dates

Study start: 2016
Primary completion: 2019
Study completion: 2019
First posted: Aug 18, 2020
Registry last updated: Aug 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed