Perioperative Oral Nutrition Supplementation in Malnourished Surgical Cancer Patients

International Medical University

Status: Completed

Conditions: Cancer of Breast; Cancer Colon

Treatments: 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

Study type: Interventional

Funder types: Other

Identifiers

NCT04400552

IMU R204/2017

Details and patient eligibility

About

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.

Full 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:

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.

Enrollment: 91 patients

Sex: All

Ages: 25 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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91 participants in 3 patient groups

ONS Pre-op + ONS Post-op

Active Comparator group

Description:

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

Treatment:

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

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

Active Comparator group

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

Treatment:

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

Usual intake Pre-op + ONS Post-op

Active Comparator group

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

Treatment:

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