Effectiveness of Nutritional Interventions for Cancer Patients Undergoing Chemotherapy

NCT04517708 | Completed

• 1 other identifier: 187/HĐĐĐĐHYHN
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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

Conditions

Gastric Cancer; Colon Cancer

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Intervention group

EXPERIMENTAL

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.

Other: Nutritional counseling

Control group

NO INTERVENTION

Patients had diets based on their demands

Interventions

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

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• treated by other methods such as radiation, endocrine, immunity;
• undergoing terminal palliative care;
• having contraindications to oral feeding/enteral nutrition

Sponsors & Collaborators

• Hanoi Medical University: lead
• Ministry of Health of Vietnam: collaborator

Related Publications (1)

• 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.

  PMID: 33550719 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms; Colonic Neoplasms

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2020
• First Posted: August 18, 2020
• Study Start: January 15, 2016
• Primary Completion: June 1, 2019
• Study Completion: December 15, 2019
• Last Updated: August 18, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share