Perioperative Oral Nutrition Supplementation in Malnourished Surgical Cancer Patients

NCT04400552 | Completed

• 1 other identifier: IMU R204/2017
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer of Breast; Cancer Colon

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (13)

• Change in handgrip force

  Change from baseline handgrip force at 4 months

• Change in muscle mass

  Change from baseline muscle mass at 4 months

• Change in fat mass

  Change from baseline fat mass at 4 months

• Change in serum transferrin level

  Change from baseline serum transferrin level at 4 months

• Change in hemoglobin level

  Change from baseline hemoglobin level at 4 months

Study Arms (3)

ONS Pre-op + ONS Post-op

ACTIVE COMPARATOR

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

Dietary Supplement: ONS Pre-op + ONS Post-op

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

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

Dietary Supplement: ONS Pre-op + ONS Post-op + ONS Post-op 3 months

Usual intake Pre-op + ONS Post-op

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

Dietary Supplement: Usual intake Pre-op + ONS Post-op

Interventions

ONS Pre-op + ONS Post-op DIETARY_SUPPLEMENT

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.

ONS Pre-op + ONS Post-op

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

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.

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

Usual intake Pre-op + ONS Post-op DIETARY_SUPPLEMENT

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

Usual intake Pre-op + ONS Post-op

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female from all ethnicity
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• IMU University, Malaysia: lead
• Kotra Pharma (M) Sdn Bhd: collaborator

Study Sites (1)

International Medical University

Kuala Lumpur, 57000, Malaysia

Location

Related Publications (1)

• 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.

  PMID: 34732233 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Colonic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Winnie SS Chee, PhD

  IMU University, Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: April 28, 2020
• First Posted: May 22, 2020
• Study Start: December 26, 2018
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: August 25, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)