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Perioperative Oral Nutrition Supplementation in Malnourished Surgical Cancer Patients

Primary Purpose

Cancer of Breast, Cancer Colon

Status

Completed

Phase

Not Applicable

Locations

Malaysia

Study Type

Interventional

Intervention

ONS Pre-op + ONS Post-op

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

Usual intake Pre-op + ONS Post-op

About this trial

This is an interventional supportive care trial for Cancer of Breast

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

International Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

ONS Pre-op + ONS Post-op

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

Usual intake Pre-op + ONS Post-op

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Change in body weight

Anthropometry measurement

Change in body mass index (BMI)

Anthropometry measurement

Change in serum albumin level

Serum albumin is an indicator of protein stores to assess nutritional status

Change in serum pre-albumin level

Serum pre-albumin is an indicator of protein stores to assess nutritional status

Secondary Outcome Measures

Change in handgrip force

Handgrip force is a measure of handgrip strength by dynamometer

Change in muscle mass

Muscle mass reported in kilogram is measured by bioelectrical impedance analyser

Change in fat mass

Fat mass reported in kilogram is measured by bioelectrical impedance analyser

Change in serum transferrin level

Serum transferrin is a measure of nutritional status

Change in hemoglobin level

Serum hemoglobin is a measure of nutritional status

Change in high sensitivity c-reactive protein (HsCRP) level

High sensitivity c-reactive protein (HsCRP) is a measure of inflammatory status

Change in Interleukin-6 (IL-6)

Interleukin-6 (IL-6) is a measure of inflammatory status

Change in salivary cortisol level

Salivary cortisol level is a biological marker of stress reaction

Change in energy intake

Energy intake reported in calories is a dietary measure to assess nutritional status

Change in protein intake

Protein intake reported in gram is a dietary measure to assess nutritional status

Change in Pittsburgh Sleep Quality Index (PSQI) scores

Pittsburgh Sleep Quality Index (PSQI) scores range from 0-42.Higher scores indicate poorer sleep quality

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

Length of hospital stay

Number of days participants are admitted into the hospital

Full Information

NCT ID

NCT04400552

First Posted

April 28, 2020

Last Updated

August 23, 2021

Sponsor

International Medical University

Collaborators

Kotra Pharma (M) Sdn Bhd

1. Study Identification

Unique Protocol Identification Number

NCT04400552

Brief Title

Perioperative Oral Nutrition Supplementation in Malnourished Surgical Cancer Patients

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Completed

Study Start Date

December 26, 2018 (Actual)

Primary Completion Date

June 30, 2021 (Actual)

Study Completion Date

June 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

International Medical University

Collaborators

Kotra Pharma (M) Sdn Bhd

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

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: To evaluate the baseline nutritional status of cancer patients undergoing elective surgery To evaluate the effectiveness of pre-operative ONS feeding on nutritional status in malnourished surgical cancer patients 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cancer of Breast, Cancer Colon

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Randomized controlled trial

Masking

None (Open Label)

Allocation

Randomized

Enrollment

91 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ONS Pre-op + ONS Post-op

Arm Type

Active Comparator

Arm Description

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

Arm Title

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

Arm Type

Active Comparator

Arm Description

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

Arm Title

Usual intake Pre-op + ONS Post-op

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

ONS Pre-op + ONS Post-op

Intervention Description

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.

Intervention Type

Dietary Supplement

Intervention Name(s)

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

Intervention Description

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.

Intervention Type

Dietary Supplement

Intervention Name(s)

Usual intake Pre-op + ONS Post-op

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in body weight

Description

Anthropometry measurement

Time Frame

Change from baseline body weight at 4 months

Title

Change in body mass index (BMI)

Description

Anthropometry measurement

Time Frame

Change from baseline body mass index (BMI) at 4 months

Title

Change in serum albumin level

Description

Serum albumin is an indicator of protein stores to assess nutritional status

Time Frame

Change from baseline serum albumin level at 4 months

Title

Change in serum pre-albumin level

Description

Serum pre-albumin is an indicator of protein stores to assess nutritional status

Time Frame

Change from baseline serum pre-albumin level at 4 months

Secondary Outcome Measure Information:

Title

Change in handgrip force

Description

Handgrip force is a measure of handgrip strength by dynamometer

Time Frame

Change from baseline handgrip force at 4 months

Title

Change in muscle mass

Description

Muscle mass reported in kilogram is measured by bioelectrical impedance analyser

Time Frame

Change from baseline muscle mass at 4 months

Title

Change in fat mass

Description

Fat mass reported in kilogram is measured by bioelectrical impedance analyser

Time Frame

Change from baseline fat mass at 4 months

Title

Change in serum transferrin level

Description

Serum transferrin is a measure of nutritional status

Time Frame

Change from baseline serum transferrin level at 4 months

Title

Change in hemoglobin level

Description

Serum hemoglobin is a measure of nutritional status

Time Frame

Change from baseline hemoglobin level at 4 months

Title

Change in high sensitivity c-reactive protein (HsCRP) level

Description

High sensitivity c-reactive protein (HsCRP) is a measure of inflammatory status

Time Frame

Change from baseline high sensitivity c-reactive protein (HsCRP) level at 4 months

Title

Change in Interleukin-6 (IL-6)

Description

Interleukin-6 (IL-6) is a measure of inflammatory status

Time Frame

Change from baseline Interleukin-6 (IL-6) at 4 months

Title

Change in salivary cortisol level

Description

Salivary cortisol level is a biological marker of stress reaction

Time Frame

Change from baseline salivary cortisol level at 4 months

Title

Change in energy intake

Description

Energy intake reported in calories is a dietary measure to assess nutritional status

Time Frame

Change from baseline energy intake at 4 months

Title

Change in protein intake

Description

Protein intake reported in gram is a dietary measure to assess nutritional status

Time Frame

Change from baseline protein intake at 4 months

Title

Change in Pittsburgh Sleep Quality Index (PSQI) scores

Description

Pittsburgh Sleep Quality Index (PSQI) scores range from 0-42.Higher scores indicate poorer sleep quality

Time Frame

Change from baseline Pittsburgh Sleep Quality Index (PSQI) scores at 4 months

Title

Presence of post-surgical complications

Description

Post-surgical complications are indicated by presence of wound infection, chest infection and use of antibiotics, responses are either yes or no

Time Frame

Change from baseline post-surgical complications at 3 months

Title

Length of hospital stay

Description

Number of days participants are admitted into the hospital

Time Frame

Up to 5 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Winnie SS Chee, PhD

Organizational Affiliation

International Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

International Medical University

City

Kuala Lumpur

ZIP/Postal Code

57000

Country

Malaysia

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

34732233

Citation

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.

Results Reference

derived

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Perioperative Oral Nutrition Supplementation in Malnourished Surgical Cancer Patients

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