Department of Medicine, Chulalongkorn University
Bangkok, 10330, Thailand
NCT Number: NCT06825221
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Bangkok, 10330, Thailand
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants received normal diet and in the interventional group received package of immune formula 2 meals per day for 10-14 days prior surgery.
Other names: Immune formula
Time frame: Baseline,Study day 10-14, After surgery day 5-7
C-reactive protein in mg/L
Time frame: Baseline,Study day 10-14, After surgery day 5-7
Tumor necrosis factor alpha in pg/ml
Time frame: Baseline,Study day 10-14, After surgery day 5-7
Interleukin-6 in pg/ml
Time frame: Baseline,Study day 10-14, After surgery day 5-7
Prealbumin in (g/L)
Time frame: Baseline,Study day 10-14, After surgery day 5-7
MAMC in cm
Time frame: Baseline,Study day 10-14, After surgery day 5-7
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 in kg
Time frame: Hospital stay
Complication assessment by Clavien-Dindo classification
Time frame: Hospital stay
Check number of participants at death during hospitalized stay
Time frame: 30 day after discharge
Check re-admission within 30 days after discharge
Time frame: After surgery day 5-7
Fasting blood glucose in mg/dL
Time frame: After surgery day 5-7
Time frame: Baseline,Study day 10-14
Gastrointestinal tolerance including abdominal distention,nausea,vomiting and diarrhea
Chulalongkorn University
Other
Novel Immune-modulating Formula Versus Standard Formula for Malnourished Gastrointestinal Cancer Patients Undergoing Cancer Surgery: A Randomized Controlled Trial.
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