Effectiveness of Nutritional Interventions for Cancer Patients Undergoing Chemotherapy

Gastric Cancer Clinical Trial

Official title:

Effectiveness of Nutritional Interventions for Cancer Patients Undergoing Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04517708
• Other study ID #: 187/HÐÐÐÐHYHN
• Status: Completed
• Phase: N/A
• Start date: January 15, 2016
• Est. completion date: December 15, 2019

Study information

• Verified date: August 2020
• Source: Hanoi Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 15, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colon Cancer
• Colonic Neoplasms
• Gastric Cancer
• Stomach Neoplasms

Intervention

Other:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Hanoi Medical University	Hanoi Medical University Hospital, Ministry of Health of Vietnam

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Baseline and 8 weeks
Primary	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.	Baseline and 8 weeks