Perioperative Oral Nutrition Supplementation in Malnourished Surgical Cancer Patients

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cancer of Breast, Cancer Colon

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ONS Pre-op + ONS Post-op<br>Oral nutrition supplementation (ONS) pre-operatively and post-operatively up to being discharged from hospital | Dietary Supplement: ONS Pre-op + ONS Post-op<br>* 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.<br>|
| Active Comparator: ONS Pre-op + ONS Post-op + ONS Post-op 3 months<br>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<br>* 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.<br>|
| Active Comparator: Usual intake Pre-op + ONS Post-op<br>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<br>* 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<br>|

What is the study measuring?
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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 |