Colorectal CancerIMNUTPREH-CRCNCT07653737
Immunonutrition for Prehabilitation of Patients With Colorectal Cancer Before Surgery
A study testing Oral nutritional supplement with inmmunonutrition and Standard oral nutritional supplement in people with Colorectal Cancer and Nutrition Aspect of Cancer, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal at 1 site in Spain.
Trial summary
Perioperative immunonutrition has been proposed as a strategy to modulate the inflammatory response and improve outcomes after colorectal surgery. However, clinical evidence is heterogeneous, and there are few studies that integrate morbidity outcomes with objective measures of body composition using computed… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Nutrition Aspect of Cancer
- What is being tested?
- Oral nutritional supplement with inmmunonutrition and Standard oral nutritional supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2024to 31 Mar 2026
- 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
- Patients eligible for colorectal cancer surgery
Who cannot join
- Non-surgical colorectal cancer
- End-stage liver o kidney disease
- Emergency surgery
- Previous nutritional supplements
- Hypersensitivity to arginine, omega-3, or nucleotides
- Inability for oral nutrition (dysphagia, esophageal/pyloric stenosis)
Show all 11Show fewer
- HIV infection
- Pregnancy
- Intestinal obstruction
- Active uncontrolled infection
- Dementia, advanced degenerative neurological disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Nutritional Management for Prehabilitation: Surgical and Nutritional Outcomes in Patients With Colorectal Cancer Treated With Oral Nutritional Supplements With and Without Immunonutrition.
Perioperative immunonutrition has been proposed as a strategy to modulate the inflammatory response and improve outcomes after colorectal surgery. However, clinical evidence is heterogeneous, and there are few studies that integrate morbidity outcomes with objective measures of body composition using computed tomography (CT). The objective was to compare immunonutrition versus standard enteral supplementation in surgically treated patients with colorectal cancer, evaluating postoperative complications and changes in body composition.
This study was designed as a 1:1 randomized, open-label, two-arm clinical trial: CONTROL group (standard nutritional oral supplements) and IMMUNONUTRITION (immunonutrition oral supplements). Patients were prescribed these daily oral nutritional supplements at least five days before surgery.
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PRIMARY OUTCOME: Post-surgical complications were classified as general and post-surgical; severity was assessed using the Clavien-Dindo classification and global burden with the Comprehensive Complication Index (CCI).
SECONDARY OUTCOMES: Body composition was quantified using preoperative and first postoperative CT scans, analyzing skeletal muscle mass index (SMMI), psoas area, periabdominal musculature, and fat compartments.
Intragroup changes and the percentage of change between groups were compared. An exploratory analysis was performed in patients with sarcopenia defined by SMMI cut-off points.
HYPOTHESIS:
It is expected that preoperative immunotherapy may result in less post-surgical complications and better body composition.
- Conditions
- Colorectal Cancer, Nutrition Aspect of Cancer
- Being tested
- Oral nutritional supplement with inmmunonutrition, Standard oral nutritional supplement
- Keywords
- postsurgical complications, sarcopenia, immunonutrition
- Medical subject headings
- Colorectal Neoplasms, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral nutritional supplement with inmmunonutritionDietary supplement
Oral nutritional supplements with immunonutrition (enriched with arginine, nucleotides, vitamin D and omega-3-fatty acid)
Standard oral nutritional supplementDietary supplement
Oral nutritional supplement with high protein content but not enriched with arginine or any other component of immunonutrition
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Standard oral nutritional supplements Receives: Dietary Supplement: Standard oral nutritional supplement |
| Immunonutrition | Experimental | Oral nutritional supplements with immunonutrition Receives: Dietary Supplement: Oral nutritional supplement with inmmunonutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-surgical complications
Complications were classified as general and post-surgical; severity was assessed using the Clavien-Dindo classification and global burden with the Comprehensive Complication Index (CCI).
Measured: From surgery until 90 days post-hospital discharge
Secondary outcomes (9)
Weight (Kg)
Weight of the patient at each visit
Measured: From preoperative evaluation until 90 days after hospital discharge
Height (cm)
Height of the patient at each visit
Measured: From preoperative evaluation until 90 days after hospital discharge
BMI (Kg/m2)
Body mass index of the patients calculated using weight and height
Measured: From preoperative evaluation until 90 days after hospital discharge
Weight loss (%)
Percentage of weight loss from the preoperative baseline weight of the patient
Measured: From preoperative evaluation until 90 days after hospital discharge
MUST (malnutrition universal screening tool) score.
Nutritional assessment by anthropometric methods including weight, weight loss, height, and body mass index, are used to give the MUST (malnutrition universal screening tool) score.
Measured: From preoperative evaluation until 90 days after hospital discharge
Muscle mass - SMMI (cm2/m2)
Body composition was quantified using preoperative and first postoperative CT scans, analyzing skeletal muscle mass index (SMMI), psoas area, periabdominal musculature, and fat compartments.
Measured: From preoperative evaluation until 90 days adter surgery
Psoas muscle index (cm2/m2)
Body composition was quantified using preoperative and first postoperative CT scans, analyzing skeletal muscle mass index (SMMI), psoas area and index, periabdominal musculature, and fat compartments.
Measured: From preoperative evaluation until 90 days after hospital discharge
Subcutaneous fat tissue (cm2)
Body composition was quantified using preoperative and first postoperative CT scans, analyzing skeletal muscle mass index (SMMI), psoas area, periabdominal musculature, and fat compartments.
Measured: From preoperative evaluation until 90 days after hospital discharge
Visceral fat tissue (cm2)
Body composition was quantified using preoperative and first postoperative CT scans, analyzing skeletal muscle mass index (SMMI), psoas area, periabdominal musculature, and fat compartments.
Measured: From preoperative evaluation until 90 days after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start1 Jan 2024
- Primary completion31 Dec 2025
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07653737
- Sponsor's protocol ID
- PI118/22
- Acronym
- IMNUTPREH-CRC
- Status last verified
- Jun 2026
- First submitted
- 10 Jun 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data that support the findings of this study are available on request from the corresponding author. The data are not publicly available due to privacy/ethical restrictions, as they contain information that could compromise the privacy of research participants.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Nutritional Management for Prehabilitation: Surgical and Nutritional Outcomes in Patients With Colorectal Cancer Treated With Oral Nutritional Supplements With and Without Immunonutrition.
- ClinicalTrials.gov ID
- NCT07653737
- Acronym / sponsor ID
- IMNUTPREH-CRC / PI118/22
- Conditions
- Colorectal Cancer, Nutrition Aspect of Cancer
- Keywords
- postsurgical complications, sarcopenia, immunonutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y CajalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 17 Jun 2026 (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.
Perioperative immunonutrition has been proposed as a strategy to modulate the inflammatory response and improve outcomes after colorectal surgery. However, clinical evidence is heterogeneous, and there are few studies that integrate morbidity outcomes with objective measures of body composition using computed tomography (CT). The objective was to compare immunonutrition versus standard enteral supplementation in surgically treated patients with colorectal cancer, evaluating postoperative complications and changes in body composition.
This study was designed as a 1:1 randomized, open-label, two-arm clinical trial: CONTROL group (standard nutritional oral supplements) and IMMUNONUTRITION (immunonutrition oral supplements). Patients were prescribed these daily oral nutritional supplements at least five days before surgery.
PRIMARY OUTCOME: Post-surgical complications were classified as general and post-surgical; severity was assessed using the Clavien-Dindo classification and global burden with the Comprehensive Complication Index (CCI).
SECONDARY OUTCOMES: Body composition was quantified using preoperative and first postoperative CT scans, analyzing skeletal muscle mass index (SMMI), psoas area, periabdominal musculature, and fat compartments.
Intragroup changes and the percentage of change between groups were compared. An exploratory analysis was performed in patients with sarcopenia defined by SMMI cut-off points.
HYPOTHESIS:
It is expected that preoperative immunotherapy may result in less post-surgical complications and better body composition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Dietary Supplement: Standard oral nutritional supplementStandard oral nutritional supplements |
| Immunonutrition | Experimental | Dietary Supplement: Oral nutritional supplement with inmmunonutritionOral nutritional supplements with immunonutrition |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients eligible for colorectal cancer surgery
Key exclusion criteria (11 listed)
- Non-surgical colorectal cancer
- End-stage liver o kidney disease
- Emergency surgery
- Previous nutritional supplements
- Hypersensitivity to arginine, omega-3, or nucleotides
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 nutritional supplement with inmmunonutritionOral nutritional supplements with immunonutrition (enriched with arginine, nucleotides, vitamin D and omega-3-fatty acid) | Dietary supplement | Immunonutrition |
| Standard oral nutritional supplementOral nutritional supplement with high protein content but not enriched with arginine or any other component of immunonutrition | Dietary supplement | Control |
Primary outcome
Post-surgical complications
Time frame: From surgery until 90 days post-hospital discharge
Complications were classified as general and post-surgical; severity was assessed using the Clavien-Dindo classification and global burden with the Comprehensive Complication Index (CCI).
9 secondary outcomes
Weight (Kg)
Time frame: From preoperative evaluation until 90 days after hospital discharge
Height (cm)
Time frame: From preoperative evaluation until 90 days after hospital discharge
BMI (Kg/m2)
Time frame: From preoperative evaluation until 90 days after hospital discharge
Weight loss (%)
Time frame: From preoperative evaluation until 90 days after hospital discharge
MUST (malnutrition universal screening tool) score.
Time frame: From preoperative evaluation until 90 days after hospital discharge
Muscle mass - SMMI (cm2/m2)
Time frame: From preoperative evaluation until 90 days adter surgery
Psoas muscle index (cm2/m2)
Time frame: From preoperative evaluation until 90 days after hospital discharge
Subcutaneous fat tissue (cm2)
Time frame: From preoperative evaluation until 90 days after hospital discharge
Visceral fat tissue (cm2)
Time frame: From preoperative evaluation until 90 days after hospital discharge
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 17 Jun 2026.
- Individual participant dataSharing planned: No. The data that support the findings of this study are available on request from the corresponding author. The data are not publicly available due to privacy/ethical restrictions, as they contain information that could compromise the privacy of research participants.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 nutritional supplement with inmmunonutrition and Standard oral nutritional supplement in people with Colorectal Cancer and Nutrition Aspect of Cancer, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal at 1 site in Spain.
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 1 inclusion and 11 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 17 Jun 2026. 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 Spain. 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?
Post-surgical complications (time frame: From surgery until 90 days post-hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jun 2026.