Perioperative Oral Nutrition Supplementation in Malnourished Surgical Cancer Patients
- Conditions
- Cancer ColonCancer of Breast
- Interventions
- Dietary Supplement: ONS Pre-op + ONS Post-opDietary Supplement: ONS Pre-op + ONS Post-op + ONS Post-op 3 monthsDietary Supplement: Usual intake Pre-op + ONS Post-op
- Registration Number
- NCT04400552
- Lead Sponsor
- International Medical University
- 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 91
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ONS Pre-op + ONS Post-op ONS Pre-op + ONS Post-op Oral nutrition supplementation (ONS) pre-operatively and post-operatively up to being discharged from hospital ONS Pre-op + ONS Post-op + ONS Post-op 3 months ONS Pre-op + ONS Post-op + ONS Post-op 3 months 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 Usual intake Pre-op + ONS Post-op Usual intake Pre-op + ONS Post-op Follow a meal plan of 2000 kcal / day using conventional foods and oral nutrition supplementation (ONS) post-operatively up to being discharged from hospital
- Primary Outcome Measures
Name Time Method Change in body weight Change from baseline body weight at 4 months Anthropometry measurement
Change in body mass index (BMI) Change from baseline body mass index (BMI) at 4 months Anthropometry measurement
Change in serum albumin level Change from baseline serum albumin level at 4 months Serum albumin is an indicator of protein stores to assess nutritional status
Change in serum pre-albumin level Change from baseline serum pre-albumin level at 4 months Serum pre-albumin is an indicator of protein stores to assess nutritional status
- Secondary Outcome Measures
Name Time Method Change in handgrip force Change from baseline handgrip force at 4 months Handgrip force is a measure of handgrip strength by dynamometer
Length of hospital stay Up to 5 days Number of days participants are admitted into the hospital
Change in muscle mass Change from baseline muscle mass at 4 months Muscle mass reported in kilogram is measured by bioelectrical impedance analyser
Change in Interleukin-6 (IL-6) Change from baseline Interleukin-6 (IL-6) at 4 months Interleukin-6 (IL-6) is a measure of inflammatory status
Change in salivary cortisol level Change from baseline salivary cortisol level at 4 months Salivary cortisol level is a biological marker of stress reaction
Change in protein intake Change from baseline protein intake at 4 months Protein intake reported in gram is a dietary measure to assess nutritional status
Change in high sensitivity c-reactive protein (HsCRP) level Change from baseline high sensitivity c-reactive protein (HsCRP) level at 4 months High sensitivity c-reactive protein (HsCRP) is a measure of inflammatory status
Change in energy intake Change from baseline energy intake at 4 months Energy intake reported in calories is a dietary measure to assess nutritional status
Change in Pittsburgh Sleep Quality Index (PSQI) scores Change from baseline Pittsburgh Sleep Quality Index (PSQI) scores at 4 months Pittsburgh Sleep Quality Index (PSQI) scores range from 0-42.Higher scores indicate poorer sleep quality
Presence of post-surgical complications Change from baseline post-surgical complications at 3 months Post-surgical complications are indicated by presence of wound infection, chest infection and use of antibiotics, responses are either yes or no
Change in fat mass Change from baseline fat mass at 4 months Fat mass reported in kilogram is measured by bioelectrical impedance analyser
Change in serum transferrin level Change from baseline serum transferrin level at 4 months Serum transferrin is a measure of nutritional status
Change in hemoglobin level Change from baseline hemoglobin level at 4 months Serum hemoglobin is a measure of nutritional status
Trial Locations
- Locations (1)
International Medical University
🇲🇾Kuala Lumpur, Malaysia