Malnutrition, Cancer
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTOral Nutrition supplement
Participants received normal diet and in the interventional group received package of immune formula 2 meals per day for 10-14 days prior surgery.
Sponsors
Chulalongkorn University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
* The same sachet, taste, and appearance for both formula * Care provider and outcome assessor will be blinded for study arm of the participants.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants who were malnourished gastrointestinal cancer patients and plan to treatment with surgery * Participant aged ≥18 years
Exclusion criteria
* Participants who weren't willing to participate in a clinical trial. * Participants who were pregnant or lactating * Participants who were enteral feeding intolerance such as gastrointestinal obstruction * Participants who receive jejunal feeding * Participant has been taking an immune formula prior to the baseline visit. * Participants who were allergic to components of the study formula such as milk,soy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in C-reactive protein | Baseline,Study day 10-14, After surgery day 5-7 | C-reactive protein in mg/L |
| Change in Tumor necrosis factor alpha (TNF-α) | Baseline,Study day 10-14, After surgery day 5-7 | Tumor necrosis factor alpha in pg/ml |
| Change in interleukin-6 (IL-6) | Baseline,Study day 10-14, After surgery day 5-7 | Interleukin-6 in pg/ml |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Handgrip strength | Baseline,Study day 10-14, After surgery day 5-7 | Handgrip strength in kg |
| Complication during hospitalized stay | Hospital stay | Complication assessment by Clavien-Dindo classification |
| Rate of death during hospitalized stay | Hospital stay | Check number of participants at death during hospitalized stay |
| Change in Prealbumin | Baseline,Study day 10-14, After surgery day 5-7 | Prealbumin in (g/L) |
| Fasting blood glucose | After surgery day 5-7 | Fasting blood glucose in mg/dL |
| Insulin (Homa IR) | After surgery day 5-7 | — |
| Gastrointestinal tolerance | Baseline,Study day 10-14 | Gastrointestinal tolerance including abdominal distention,nausea,vomiting and diarrhea |
| Rate of re-admission within 30 days | 30 day after discharge | Check re-admission within 30 days after discharge |
| Mid-upper arm circumference | Baseline,Study day 10-14, After surgery day 5-7 | MAMC in cm |
| BIA | Baseline,Study day 10-14, After surgery day 5-7 | BIA is body composition analysis in muscle mass, fat mass,% body fat |
Countries
Thailand
Outcome results
None listed