Perioperative Oral Nutrition Supplementation in Malnourished Surgical Cancer Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Cancer of Breast; Cancer Colon
• Intervention / Treatment: Dietary supplement: ONS Pre-op + ONS Post-op; Dietary supplement: ONS Pre-op + ONS Post-op + ONS Post-op 3 months; Dietary supplement: Usual intake Pre-op + ONS Post-op

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 91
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Kuala Lumpur, Malaysia, 57000
    • International Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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
• Fulfil at least two characteristics of AND/ ASPEN Diagnosis of Malnutrition These characteristics are insufficient energy intake, weight loss, loss of muscle mass, loss of subcutaneous fat, localized or generalized fluid accumulation and diminished functional status as measured by handgrip strength.

Exclusion Criteria:

• Patients who require enteral or parenteral feeding
• Pregnant or lactating
• On chemotherapy or radiotherapy
• Total gastrectomy or ileostomy
• Metastasized cancer, upper gastrointestinal cancer, terminal diseases, decompensated liver or renal disease, major concurrent metabolic problem such as uncontrolled diabetes, dementia
• On regular steroids prescription

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ONS Pre-op + ONS Post-op; Oral nutrition supplementation (ONS) pre-operatively and post-operatively up to being discharged from hospital	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.
Active Comparator: ONS Pre-op + ONS Post-op + ONS Post-op 3 months; 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	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.
Active Comparator: Usual intake Pre-op + ONS Post-op; Follow a meal plan of 2000 kcal / day using conventional foods and oral nutrition supplementation (ONS) post-operatively up to being discharged from hospital	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in body weight	Anthropometry measurement	Change from baseline body weight at 4 months
Change in body mass index (BMI)	Anthropometry measurement	Change from baseline body mass index (BMI) at 4 months
Change in serum albumin level	Serum albumin is an indicator of protein stores to assess nutritional status	Change from baseline serum albumin level at 4 months
Change in serum pre-albumin level	Serum pre-albumin is an indicator of protein stores to assess nutritional status	Change from baseline serum pre-albumin level at 4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in handgrip force	Handgrip force is a measure of handgrip strength by dynamometer	Change from baseline handgrip force at 4 months
Change in muscle mass	Muscle mass reported in kilogram is measured by bioelectrical impedance analyser	Change from baseline muscle mass at 4 months
Change in fat mass	Fat mass reported in kilogram is measured by bioelectrical impedance analyser	Change from baseline fat mass at 4 months
Change in serum transferrin level	Serum transferrin is a measure of nutritional status	Change from baseline serum transferrin level at 4 months
Change in hemoglobin level	Serum hemoglobin is a measure of nutritional status	Change from baseline hemoglobin level at 4 months
Change in high sensitivity c-reactive protein (HsCRP) level	High sensitivity c-reactive protein (HsCRP) is a measure of inflammatory status	Change from baseline high sensitivity c-reactive protein (HsCRP) level at 4 months
Change in Interleukin-6 (IL-6)	Interleukin-6 (IL-6) is a measure of inflammatory status	Change from baseline Interleukin-6 (IL-6) at 4 months
Change in salivary cortisol level	Salivary cortisol level is a biological marker of stress reaction	Change from baseline salivary cortisol level at 4 months
Change in energy intake	Energy intake reported in calories is a dietary measure to assess nutritional status	Change from baseline energy intake at 4 months
Change in protein intake	Protein intake reported in gram is a dietary measure to assess nutritional status	Change from baseline protein intake at 4 months
Change in Pittsburgh Sleep Quality Index (PSQI) scores	Pittsburgh Sleep Quality Index (PSQI) scores range from 0-42.Higher scores indicate poorer sleep quality	Change from baseline Pittsburgh Sleep Quality Index (PSQI) scores at 4 months
Presence of post-surgical complications	Post-surgical complications are indicated by presence of wound infection, chest infection and use of antibiotics, responses are either yes or no	Change from baseline post-surgical complications at 3 months
Length of hospital stay	Number of days participants are admitted into the hospital	Up to 5 days

Collaborators and Investigators

• Sponsor: International Medical University
• Collaborators: Kotra Pharma (M) Sdn Bhd
• Investigators: Principal Investigator: Winnie SS Chee, PhD, International Medical University

Publications and helpful links

General Publications

• Wong TX, Chen ST, Ong SH, Shyam S, Kandasami P, Chee WSS. Study protocol for an open labelled randomised controlled trial of perioperative oral nutrition supplement in breast and colorectal cancer patients undergoing elective surgery. Trials. 2021 Nov 3;22(1):767. doi: 10.1186/s13063-021-05716-5.

Study record dates

Study Major Dates

• Study Start (Actual): December 26, 2018
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: April 28, 2020
• First Submitted That Met QC Criteria: May 19, 2020
• First Posted (Actual): May 22, 2020

Study Record Updates

• Last Update Posted (Actual): August 25, 2021
• Last Update Submitted That Met QC Criteria: August 23, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: IMU R204/2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No