Malnutrition is a common feature in cancer patients and associated with worse outcomes especially increased risk of postoperative complications in patients undergoing surgery. The European Society for Clinical Nutrition and Metabolism (ESPEN) recommends preoperative oral/enteral immunonutrition support to decrease risk of postoperative complications. However, the evidence comparing between immune formula and standard formula is still controversial. Numerous studies have indicated that curcumin is beneficial to the immune system. This study aimed to assess the effect of an immune formula which contains curcumin versus standard formula for malnourished gastrointestinal cancer patients undergoing cancer surgery. A randomized controlled trial will be conducted on 40 malnourished gastrointestinal cancer patients who plan to undergo major cancer surgery. Patients in the intervention group will receive 2 sachets of immune formula per day (355.5 kcal and curcumin 25 mg per sachet) for 10-14 days and dietary counseling. Participants in the control group will receive 2 sachets of isocaloric standard formula per day for 10-14 days and dietary counseling. Anthropometry and biochemical parameters were measured in 3 periods (before intervention, two weeks after intervention in preoperative, and post-operative period). Postoperative complications were recorded until patient discharge from hospital for 30 days.
Malnutrition is a common feature in cancer patients and associated with worse outcomes especially increased risk of postoperative complications in patients undergoing surgery. The European Society for Clinical Nutrition and Metabolism (ESPEN) recommends preoperative oral/enteral immunonutrition support to decrease risk of postoperative complications especially in malnourished patients undergoing major abdominal surgery. Numerous studies have indicated that curcumin is beneficial to the immune system. This study aimed to assess the effect of an immune formula which contains curcumin versus standard formula for malnourished gastrointestinal cancer patients undergoing cancer surgery. A randomized controlled trial will be conducted on 40 malnourished gastrointestinal cancer patients who plan to undergo major cancer surgery. Patients in the intervention group will receive 2 sachets of immune formula per day (355.5 kcal and curcumin 25 mg per sachet) for 10-14 days and dietary counseling. Participants in the control group will receive 2 sachets of isocaloric standard formula per day for 10-14 days and dietary counseling. Body mass index (BMI), body composition, mid-arm muscle circumference (MAMC), hand grip strength, food intake, pre-albumin, C-reactive protein (CRP), Interleukin-6 (IL-6), and Tumor necrosis factor alpha (TNF-alpha) are measured at the day before and the day after having all of oral nutrition supplements. Parameters are re-measured within 5-7 days after operation along with fasting blood sugar, insulin and HOMAR-IR. Postoperative complications are assessed with Clavien-Dindo classification on the last day in the hospital. Re-admit rates are recorded until 30 days after discharge.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
30
Participants received normal diet and in the interventional group received package of immune formula 2 meals per day for 10-14 days prior surgery.
Department of Medicine, Chulalongkorn University
Bangkok, Thailand
Change in C-reactive protein
C-reactive protein in mg/L
Time frame: Baseline,Study day 10-14, After surgery day 5-7
Change in Tumor necrosis factor alpha (TNF-α)
Tumor necrosis factor alpha in pg/ml
Time frame: Baseline,Study day 10-14, After surgery day 5-7
Change in interleukin-6 (IL-6)
Interleukin-6 in pg/ml
Time frame: Baseline,Study day 10-14, After surgery day 5-7
Change in Prealbumin
Prealbumin in (g/L)
Time frame: Baseline,Study day 10-14, After surgery day 5-7
Mid-upper arm circumference
MAMC in cm
Time frame: Baseline,Study day 10-14, After surgery day 5-7
BIA
BIA is body composition analysis in muscle mass, fat mass,% body fat
Time frame: Baseline,Study day 10-14, After surgery day 5-7
Handgrip strength
Handgrip strength in kg
Time frame: Baseline,Study day 10-14, After surgery day 5-7
Complication during hospitalized stay
Complication assessment by Clavien-Dindo classification
Time frame: Hospital stay
Rate of death during hospitalized stay
Check number of participants at death during hospitalized stay
Time frame: Hospital stay
Rate of re-admission within 30 days
Check re-admission within 30 days after discharge
Time frame: 30 day after discharge
Fasting blood glucose
Fasting blood glucose in mg/dL
Time frame: After surgery day 5-7
Insulin (Homa IR)
Time frame: After surgery day 5-7
Gastrointestinal tolerance
Gastrointestinal tolerance including abdominal distention,nausea,vomiting and diarrhea
Time frame: Baseline,Study day 10-14
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