Perioperative Oral Nutrition Supplementation in Malnourished Surgical Cancer Patients

IMU University, Malaysia91 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Interventions

ONS Pre-op + ONS Post-opDIETARY_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 Post-op 3 monthsDIETARY_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.

Usual intake Pre-op + ONS Post-opDIETARY_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

Eligibility

Sex: ALLMin age: 25 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

International Medical University

Kuala Lumpur, Malaysia

Outcomes

Primary Outcomes

Change in body weight

Anthropometry measurement

Time frame: Change from baseline body weight at 4 months

Change in body mass index (BMI)

Anthropometry measurement

Time frame: 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

Time frame: 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

Time frame: Change from baseline serum pre-albumin level at 4 months

Secondary Outcomes

Change in handgrip force

Handgrip force is a measure of handgrip strength by dynamometer

Time frame: Change from baseline handgrip force at 4 months

Change in muscle mass

Muscle mass reported in kilogram is measured by bioelectrical impedance analyser

Time frame: Change from baseline muscle mass at 4 months

Change in fat mass

Fat mass reported in kilogram is measured by bioelectrical impedance analyser

Time frame: Change from baseline fat mass at 4 months

Change in serum transferrin level

Serum transferrin is a measure of nutritional status

Time frame: Change from baseline serum transferrin level at 4 months

Change in hemoglobin level

Serum hemoglobin is a measure of nutritional status

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Change from baseline post-surgical complications at 3 months

Length of hospital stay

Number of days participants are admitted into the hospital

Time frame: Up to 5 days

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.