Effectiveness of Nutritional Interventions for Cancer Patients Undergoing Chemotherapy

NCT ID: NCT04517708

Last Updated: 2020-08-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-15
• Study Completion Date: 2019-12-15

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.

Conditions

Gastric Cancer; Colon Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Intervention group

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.

Group Type: EXPERIMENTAL

Nutritional counseling

Intervention Type: 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

Control group

Patients had diets based on their demands

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health of Vietnam

UNKNOWN

Sponsor Role: collaborator

Hanoi Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

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.

Reference Type: DERIVED

PMID: 33550719 (View on PubMed)

Other Identifiers

187/HĐĐĐĐHYHN

Identifier Type: -

Identifier Source: org_study_id