Completed

Perioperative Oral Nutrition Supplementation in Malnourished Surgical Cancer Patients- A Randomized Controlled Trial

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What is being tested

ONS Pre-op + ONS Post-op

+ ONS Pre-op + ONS Post-op + ONS Post-op 3 months

+ Usual intake Pre-op + ONS Post-op

Dietary Supplement
Who is being recruted

Breast Diseases+12

+ Breast Neoplasms

+ Colonic Diseases

From 25 to 65 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Supportive Care Study

Interventional
Study Start: December 2018
See protocol details

Summary

Principal SponsorIMU University, Malaysia
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: December 26, 2018

Actual date on which the first participant was enrolled.

The main objective of this study is to evaluate the effectiveness of perioperative oral nutrition supplementation (ONS) on nutritional status in malnourished cancer patients undergoing elective surgery. The specific objectives are: 1. To evaluate the baseline nutritional status of cancer patients undergoing elective surgery 2. To evaluate the effectiveness of pre-operative ONS feeding on nutritional status in malnourished surgical cancer patients 3. To evaluate the effectiveness of an extended 3 months post-operative ONS feeding after discharge versus ONS feeding only post-operatively during hospital on nutritional status 4. To evaluate secondary outcomes of perioperative feeding such as sleep quality, post-operative complications and length of hospital stay Study Design: This is a randomised-controlled-open label-parallel group(s)-trial which will be conducted on malnourished cancer patients undergoing elective surgery. Study duration: The participation duration for each participant is 4 months. The completion of the study will take around 30 months.

Official TitlePerioperative Oral Nutrition Supplementation in Malnourished Surgical Cancer Patients- A Randomized Controlled Trial
NCT04400552
Principal SponsorIMU University, Malaysia
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

91 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 25 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Breast DiseasesBreast NeoplasmsColonic DiseasesColonic NeoplasmsDigestive System DiseasesDigestive System NeoplasmsGastrointestinal DiseasesGastrointestinal NeoplasmsIntestinal DiseasesIntestinal NeoplasmsNeoplasmsNeoplasms by SiteSkin DiseasesColorectal NeoplasmsSkin and Connective Tissue Diseases

Criteria

5 inclusion criteria required to participate
Male or female from all ethnicity
25 to 65 years
BMI not less than 18.0 kg/m²
Cancer patients who are confirmed with elective surgery whose co-morbidities are stabilized based on the ASA Physical Status Classification System ASA Class 1 and 2
Show More Criteria
6 exclusion criteria prevent from participating
Patients who require enteral or parenteral feeding
Pregnant or lactating
On chemotherapy or radiotherapy
Total gastrectomy or ileostomy
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
Oral nutrition supplementation (ONS) pre-operatively and post-operatively up to being discharged from hospital

Group II

Active Comparator
Oral nutrition supplementation (ONS) pre-operatively, post-operatively up to being discharged from hospital and an extended oral nutrition supplementation post-operatively up to 3 months

Group III

Active Comparator
Follow a meal plan of 2000 kcal / day using conventional foods and oral nutrition supplementation (ONS) post-operatively up to being discharged from hospital

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

International Medical University

Kuala Lumpur, MalaysiaOpen International Medical University in Google Maps
CompletedOne Study Center