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Completed

NCT Number: NCT06825221

Effect of Immune Formula in Gastrointestinal Cancer Patients Undergoing Cancer Surgery

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Medicine, Chulalongkorn University

Bangkok, 10330, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oral Nutrition supplement

Dietary 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.

Other names: Immune formula

Primary outcomes

  1. Change in C-reactive protein

    Time frame: Baseline,Study day 10-14, After surgery day 5-7

    C-reactive protein in mg/L

  2. Change in Tumor necrosis factor alpha (TNF-α)

    Time frame: Baseline,Study day 10-14, After surgery day 5-7

    Tumor necrosis factor alpha in pg/ml

  3. Change in interleukin-6 (IL-6)

    Time frame: Baseline,Study day 10-14, After surgery day 5-7

    Interleukin-6 in pg/ml

Secondary outcomes

  1. Change in Prealbumin

    Time frame: Baseline,Study day 10-14, After surgery day 5-7

    Prealbumin in (g/L)

  2. Mid-upper arm circumference

    Time frame: Baseline,Study day 10-14, After surgery day 5-7

    MAMC in cm

  3. BIA

    Time frame: Baseline,Study day 10-14, After surgery day 5-7

    BIA is body composition analysis in muscle mass, fat mass,% body fat

  4. Handgrip strength

    Time frame: Baseline,Study day 10-14, After surgery day 5-7

    Handgrip strength in kg

  5. Complication during hospitalized stay

    Time frame: Hospital stay

    Complication assessment by Clavien-Dindo classification

  6. Rate of death during hospitalized stay

    Time frame: Hospital stay

    Check number of participants at death during hospitalized stay

  7. Rate of re-admission within 30 days

    Time frame: 30 day after discharge

    Check re-admission within 30 days after discharge

  8. Fasting blood glucose

    Time frame: After surgery day 5-7

    Fasting blood glucose in mg/dL

  9. Insulin (Homa IR)

    Time frame: After surgery day 5-7

  10. Gastrointestinal tolerance

    Time frame: Baseline,Study day 10-14

    Gastrointestinal tolerance including abdominal distention,nausea,vomiting and diarrhea

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Registry information

Official study title

Novel Immune-modulating Formula Versus Standard Formula for Malnourished Gastrointestinal Cancer Patients Undergoing Cancer Surgery: A Randomized Controlled Trial.

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 13, 2025
Registry last updated
Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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