MalnutritionNCT06825221
Effect of Immune Formula in Gastrointestinal Cancer Patients Undergoing Cancer Surgery
A study testing Oral Nutrition supplement in people with Malnutrition and Cancer, run by Chulalongkorn University at 1 site in Thailand.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malnutrition, Cancer
- What is being tested?
- Oral Nutrition supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteThailand
- Study dates
- 1 Apr 2023to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants who were malnourished gastrointestinal cancer patients and plan to treatment with surgery
- Participant aged ≥18 years
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Department of Medicine, Chulalongkorn University
Bangkok, 10330
About this study
Official title: Novel Immune-modulating Formula Versus Standard Formula for Malnourished Gastrointestinal Cancer Patients Undergoing Cancer Surgery: A Randomized Controlled Trial.
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.
Read the 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.
- Conditions
- Malnutrition, Cancer
- Being tested
- Oral Nutrition supplement
- Medical subject headings
- Malnutrition, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Nutrition supplementDietary supplement
Also called Immune formula
Participants received normal diet and in the interventional group received package of immune formula 2 meals per day for 10-14 days prior surgery.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Participants receive 2 packages of immune formula per day for 10-14 days + dietary counseling Receives: Dietary Supplement: Oral Nutrition supplement |
| Control group | No intervention | Participants receive 2 packages of standard formula per day for 10-14 days + dietary counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in C-reactive protein
C-reactive protein in mg/L
Measured: 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
Measured: Baseline,Study day 10-14, After surgery day 5-7
Change in interleukin-6 (IL-6)
Interleukin-6 in pg/ml
Measured: Baseline,Study day 10-14, After surgery day 5-7
Secondary outcomes (10)
Change in Prealbumin
Prealbumin in (g/L)
Measured: Baseline,Study day 10-14, After surgery day 5-7
Mid-upper arm circumference
MAMC in cm
Measured: Baseline,Study day 10-14, After surgery day 5-7
BIA
BIA is body composition analysis in muscle mass, fat mass,% body fat
Measured: Baseline,Study day 10-14, After surgery day 5-7
Handgrip strength
Handgrip strength in kg
Measured: Baseline,Study day 10-14, After surgery day 5-7
Complication during hospitalized stay
Complication assessment by Clavien-Dindo classification
Measured: Hospital stay
Rate of death during hospitalized stay
Check number of participants at death during hospitalized stay
Measured: Hospital stay
Rate of re-admission within 30 days
Check re-admission within 30 days after discharge
Measured: 30 day after discharge
Fasting blood glucose
Fasting blood glucose in mg/dL
Measured: After surgery day 5-7
Insulin (Homa IR)
Measured: After surgery day 5-7
Gastrointestinal tolerance
Gastrointestinal tolerance including abdominal distention,nausea,vomiting and diarrhea
Measured: Baseline,Study day 10-14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study start1 Apr 2023
- Primary completion31 Jul 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Narisorn Lakananurak, Doctor, Principal investigator, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06825221
- Sponsor's protocol ID
- 0711/65
- Status last verified
- Jan 2025
- First submitted
- 10 Feb 2025
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lakananurak N, Laosuwan P, Vongwattanakit P, Jittivasurat A, Techasukthavorn V. Novel immune-modulating formula versus standard formula for gastrointestinal cancer patients at risk of malnutrition undergoing surgery: A pilot randomized controlled trial. Clin Nutr ESPEN. 2026 Apr;72:102909. doi: 10.1016/j.clnesp.2026.102909. Epub 2026 Jan 10.
PubMed 41525872
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Immune-modulating Formula Versus Standard Formula for Malnourished Gastrointestinal Cancer Patients Undergoing Cancer Surgery: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT06825221
- Acronym / sponsor ID
- 0711/65
- Conditions
- Malnutrition, Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 13 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Dietary Supplement: Oral Nutrition supplementParticipants receive 2 packages of immune formula per day for 10-14 days + dietary counseling |
| Control group | No intervention | –Participants receive 2 packages of standard formula per day for 10-14 days + dietary counseling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participants who were malnourished gastrointestinal cancer patients and plan to treatment with surgery
- Participant aged ≥18 years
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral Nutrition supplementAlso: Immune formulaParticipants received normal diet and in the interventional group received package of immune formula 2 meals per day for 10-14 days prior surgery. | Dietary supplement | Intervention group |
Primary outcome
Change in C-reactive protein
Time frame: Baseline,Study day 10-14, After surgery day 5-7
C-reactive protein in mg/L
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
Change in interleukin-6 (IL-6)
Time frame: Baseline,Study day 10-14, After surgery day 5-7
Interleukin-6 in pg/ml
10 secondary outcomes
Change in Prealbumin
Time frame: Baseline,Study day 10-14, After surgery day 5-7
Mid-upper arm circumference
Time frame: Baseline,Study day 10-14, After surgery day 5-7
BIA
Time frame: Baseline,Study day 10-14, After surgery day 5-7
Handgrip strength
Time frame: Baseline,Study day 10-14, After surgery day 5-7
Complication during hospitalized stay
Time frame: Hospital stay
Rate of death during hospitalized stay
Time frame: Hospital stay
Rate of re-admission within 30 days
Time frame: 30 day after discharge
Fasting blood glucose
Time frame: After surgery day 5-7
Insulin (Homa IR)
Time frame: After surgery day 5-7
Gastrointestinal tolerance
Time frame: Baseline,Study day 10-14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Derived from this study: PubMed 41525872Lakananurak N, Laosuwan P, Vongwattanakit P, Jittivasurat A, Techasukthavorn V. Novel immune-modulating formula versus standard formula for gastrointestinal cancer patients at risk of malnutrition undergoing surgery: A pilot randomized controlled trial. Clin Nutr ESPEN. 2026 Apr;72:102909. doi: 10.1016/j.clnesp.2026.102909. Epub 2026 Jan 10.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Narisorn Lakananurak, Doctor principal investigator
Chulalongkorn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Nutrition supplement in people with Malnutrition and Cancer, run by Chulalongkorn University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in C-reactive protein (time frame: Baseline,Study day 10-14, After surgery day 5-7). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06825221, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.