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.

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.

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