Cancer Colon, Cancer of Breast
Conditions
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.
Interventions
DIETARY_SUPPLEMENTONS Pre-op + ONS Post-op
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.
DIETARY_SUPPLEMENTONS Pre-op + ONS Post-op + ONS Post-op 3 months
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.
DIETARY_SUPPLEMENTUsual intake Pre-op + ONS Post-op
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
Sponsors
Kotra Pharma (M) Sdn Bhd
IMU University, Malaysia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Change in hemoglobin level | Change from baseline hemoglobin level at 4 months | Serum hemoglobin is a measure of 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 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 handgrip force | Change from baseline handgrip force at 4 months | Handgrip force is a measure of handgrip strength by dynamometer |
| 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 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 |
| Length of hospital stay | Up to 5 days | Number of days participants are admitted into the hospital |
| 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 muscle mass | Change from baseline muscle mass at 4 months | Muscle mass reported in kilogram is measured by bioelectrical impedance analyser |
| 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 |
Countries
Malaysia
Outcome results
None listed