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Effectiveness of Nutritional Interventions for Cancer Patients Undergoing Chemotherapy

Effectiveness of Nutritional Interventions for Cancer Patients Undergoing Chemotherapy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04517708
Enrollment
120
Registered
2020-08-18
Start date
2016-01-15
Completion date
2019-12-15
Last updated
2020-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon Cancer, Gastric Cancer

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.

Interventions

OTHERNutritional 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

Sponsors

Ministry of Health of Vietnam
CollaboratorUNKNOWN
Hanoi Medical University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change of nutritional status after 8 weeksBaseline and 8 weeksThe 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 3.0Baseline and 8 weeksWe 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 16, 2026