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Immune formula versus standard formula for malnourished gastrointestinal cancer patients undergoing cancer surgery: A randomized controlled trial

Immune formula versus standard formula for malnourished gastrointestinal cancer patients undergoing cancer surgery: A randomized controlled trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20240319004
Enrollment
40
Registered
2024-03-19
Start date
2023-04-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

To study about patients who are malnourished gastrointestinal cancer patients and plan to undergo major abdominal surgery. If these patients receive immunonutrition supplement before surgery, can improve nutrition outcome and complication. malnutrition cancer curcumin immunonutrition surgery

Interventions

Participants receive 2 packages of immune formula per day for 10-14 days + dietary counseling,Participants receive 2 packages of standard formula per day for 10-14 days + dietary counseling
Intervention group: Oral nutrition supplement,Control group

Sponsors

Banpong Novitat
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Participants who are malnourished gastrointestinal cancer patients and plan to undergo major abdominal surgery 2. Participants aged greater than or equal to 18 years

Exclusion criteria

Exclusion criteria: 1.Participants who are not willing to participate in a clinical trial. 2.Pregnancy or lactation 3.Participants who cannot receive enteral feeding such as gastrointestinal obstruction 4.Participants who receive small bowel feeding 5.Participants who have been taking an immune formula prior to the baseline visit 6.Participants who are allergic to components of the study formula such as milk, soy.

Design outcomes

Primary

MeasureTime frame
Change in C-reactive protein Baseline,Study day 10-14, After surgery day 5-7 mg/L,Change in Tumor necrosis factor alpha Baseline,Study day 10-14, After surgery day 5-7 pg/ml,Change in interleukin-6 Baseline,Study day 10-14, After surgery day 5-7 pg/ml

Secondary

MeasureTime frame
Change in Prealbumin Baseline,Study day 10-14, After surgery day 5-7 g/L,Mid-upper arm circumference Baseline,Study day 10-14, After surgery day 5-7 cm,BIA Baseline,Study day 10-14, After surgery day 5-7 BIA is body composition analysis in muscle mass, fat mass,% body fat,Handgrip strength Baseline,Study day 10-14, After surgery day 5-7 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,Rate of re-admission within 30 days 30 day after discharge Check re-admission within 30 days after discharge,Fasting blood glucose After surgery day 5-7 mg/dL,Insulin After surgery day 5-7 Homa IR,Gastrointestinal toleranc Baseline,Study day 10-14 Gastrointestinal tolerance including abdominal distention,nausea,vomiting and diarrhea

Countries

Thailand

Contacts

Public ContactNarisorn Lakananurak

Faculty of Medicine,Chulalongkorn University

Narisorn.l@chula.ac.th0853347979

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026