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Perioperative Oral Nutrition Supplementation in Malnourished Surgical Cancer Patients

NCT04400552 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 91

Last updated 2021-08-25

No results posted yet for this study

Summary

The aim 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 hypothesis is pre-operative ONS feeding in malnourished surgical cancer patients is effective on improving nutritional status. An extended period of 3 months post-operative ONS feeding is effective on improving nutritional status as compared to ONS feeding post-operatively during hospital stay only. Perioperative feeding is effective on improving secondary outcomes such as sleep quality, post-operative complications and length of hospital stay.

Conditions

  • Cancer of Breast
  • Cancer Colon

Interventions

DIETARY_SUPPLEMENT

ONS Pre-op + ONS Post-op

Participants will consume the oral nutrition supplementation (ONS) in addition to normal diet for 14 days pre-operatively and post-operatively up to participants being discharged from the hospital.

DIETARY_SUPPLEMENT

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

Participants will consume the oral nutrition supplementation (ONS) in addition to normal diet for 14 days pre-operatively, post-operatively up to participants being discharged from the hospital and an extended oral nutrition supplementation post-operatively up to 3 months.

DIETARY_SUPPLEMENT

Usual intake Pre-op + ONS Post-op

Participants will follow a meal plan of 2000 kcal / day using conventional foods for 14 days pre-operatively and consume oral nutrition supplementation (ONS) in addition to normal diet post-operatively up to participants being discharged from the hospital

Sponsors & Collaborators

  • Kotra Pharma (M) Sdn Bhd

    collaborator UNKNOWN

  • IMU University, Malaysia

    lead OTHER

Principal Investigators

  • Winnie SS Chee, PhD · IMU University, Malaysia

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-26
Primary Completion
2021-06-30
Completion
2021-06-30

Countries

  • Malaysia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04400552 on ClinicalTrials.gov