Colorectal CancerNUTRICOLORNCT07599501
Nutritional Supplementation to Improve Colorectal Cancer Surgery
A study testing Diet Optimization (DO) and Oral Nutritional Supplement (ONS) in people with Colorectal Cancer and Colorectal Surgery, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial summary
This study aims to explore the effectiveness of perioperative Oral Nutritional Supplementation (ONS) combined with an optimized, tailored diet in reducing the risk of postoperative complications and improving the nutritional status of colorectal cancer patients scheduled for curative colorectal resection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Colorectal Surgery
- What is being tested?
- Diet Optimization (DO) and Oral Nutritional Supplement (ONS)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteItaly
- Study dates
- 30 Sep 2026to 28 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 aged more than 18 years old.
- Histological diagnosis of colorectal adenocarcinoma.
- Participants scheduled for elective minimally invasive colorectal resection.
- Participants with a preoperative MUST score equal to or below 2. Exclusion criteria
- Any condition that, in the opinion of the investigator, may interfere with the study procedures.
- Emergent surgery.
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- Planned open surgery. Participants undergoing unplanned surgical conversion (from minimally invasive to open) will be withdrawn from the study.
- Any concomitant surgery unrelated to the primitive colorectal cancer (for example, concomitant liver metastasis resection).
- Participants with preoperative MUST score > 2.
- Pregnant or breastfeeding participants. Women of childbearing potential must agree to use a reliable contraceptive method. Otherwise, a pregnancy urine test must be performed at each study visit to exclude a potential pregnancy.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
IRCCS Humanitas Research Hospital
Rozzano, Milano, 20089
Annalisa Maroli, PhD, 00390282247776, annalisa.maroli@humanitas.it
Stefano De Zanet, MS, 00390282244623, stefano.dezanet@humanitas.it
About this study
Official title: Perioperative Nutritional Supplementation to Prevent Postoperative Complications and Improve Postoperative Outcomes After Colorectal Cancer Surgery: a Single-center Unblinded Randomized Controlled Trial
This study aims to explore the effectiveness of perioperative Oral Nutritional Supplementation (ONS) combined with an optimized, tailored diet in reducing the risk of postoperative complications and improving the nutritional status of colorectal cancer patients scheduled for curative colorectal resection.
Read the detailed description
The rate of postoperative complications after colorectal cancer surgery is around 35%. The preoperative nutritional status significantly influences the postoperative outcomes, and several studies have investigated the effect of perioperative nutritional interventions with mixed results. This study aims to explore the effect of perioperative Oral Nutritional Supplementation (ONS) on the postoperative outcomes of colorectal cancer patients receiving preoperative dietary optimization. Participants scheduled for elective curative colorectal cancer surgery will undergo a detailed preoperative nutritional screening and will be randomized to receive either an optimized diet alone or an optimized diet and perioperative ONS. Postoperative complications will be collected and registered until 60 days after surgery. The participants' nutritional status will be evaluated 60 days and 180 days after surgery.
- Conditions
- Colorectal Cancer, Colorectal Surgery
- Being tested
- Diet Optimization (DO), Oral Nutritional Supplement (ONS)
- Keywords
- Colorectal cancer, Colorectal surgery, Oral Nutritional Supplementation
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet Optimization (DO)Other
Dietary optimization will include a tailored diet to maintain or restore a good nutritional status, body composition (e.g. weight or lean mass gain if necessary), and macro/micronutrient intake in case of deficiencies detected during the nutritional screening. Participants will be instructed to follow the dietary indications throughout the study, with appropriate adjustments according to following nutritional assessments.
Oral Nutritional Supplement (ONS)Dietary supplement
ONS will consist of LH Blu® (Lionhealth Italia Srl). LH Blu® is categorized as a food for special medical purposes and is indicated for the treatment of malnourished patients. ONS will start 14 days before the planned intervention with a tailored dosage decided according to the malnutrition risk (low vs medium).
| Study group | Role | What they receive |
|---|---|---|
| Diet optimization (DO) | Active comparator | Dietary optimization will include a tailored diet to maintain or restore a good nutritional status, body composition (e.g. weight or lean mass gain if necessary), and macro/micronutrient intake in case of deficiencies detected during the nutritional screening. Participants will be instructed to follow the dietary indications throughout the study, with appropriate adjustments according to following nutritional assessments. Receives: Other: Diet Optimization (DO) |
| Diet Optimization and Oral Nutritional Supplementation (DO+ONS) | Experimental | Participants in the DO+ONS arm will receive dietary optimization and standardized oral nutritional supplementation designed according to the ESPEN guidelines. The treatment will start 14 days before surgery and will be restored the day after surgery for the following 60 days. Receives: Other: Diet Optimization (DO); Dietary Supplement: Oral Nutritional Supplement (ONS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complications
The rate of postoperative complications occurring within 30 days from surgery
Measured: 30 days from surgery
Secondary outcomes (9)
Postoperative septic complications
The rate of postoperative septic complications occurring within 30 days from surgery. Septic complications are defined according to the criteria proposed by the International Sepsis Definitions Conference and include documented postoperative extra-intestinal infections- such as urinary tract infections and pneumonia-, intra-abdominal septic complications- such as anastomotic leaks, pelvic abscesses, and peritonitis-, surgical site infections, and systemic symptoms of abnormal inflammatory response- such as fever higher than 38°C or C-Reactive Protein (CRP) increase higher than 200 mg/dL for more than two consecutive days
Measured: 30 days from surgery
Comprehensive Complication Index (CCI)
The median Comprehensive Complication Index (CCI) computed from all postoperative complications that occurred within 30 days from surgery. The CCI ranges from 0 to 100, where 0 indicates the best outcome (no postoperative complications), and 100 indicates the worst outcome (postoperative complications leading to death).
Measured: 30 days from surgery
Length of hospital stay
The median length of hospital stay calculated in days from the day after surgery until the day of discharge
Measured: 30 days from surgery
Hospital readmission
The rate of hospital readmissions- including ward readmission and emergency room accesses- within 30 days from surgery
Measured: 30 days from surgery
Sarcopenia
The proportion of participants with sarcopenia six months after surgery. Sarcopenia will be assessed from the Skeletal Muscle Index (SMI) computed from the abdominal Computed Tomography (CT) scans collected at screening and 6 months after surgery. SMI less than 7.0 kg/m2 for men and less than 5.5 kg/m2 for women will be considered indicative of sarcopenia.
Measured: Six months after surgery
Normal weight
The proportion of participants with normo-weight Body Mass Index (BMI) measures at 60 days after surgery. Normal BMI values ranges from 18.5 Kg/m2 and 24.9 Kg/m2.
Measured: 60 days after surgery
Mini Nutritional Assessment (MNA) score
The median Mini Nutritional Assessment (MNA) score collected 60 days after surgery. The MNA score ranges from 0 (worst possibile nutritional status) to 30 (best possible nutritional status).
Measured: 60 days after surgery
EuroQoL-5 Dimension- 5 Levels (EQ5D5L) score
The median EuroQoL-5 Dimension- 5 Levels (EQ5D5L) score collected 60 days after surgery. The EQ5D5L score ranges from 0 (worst possible perceived health) to 25 (best possible perceived health).
Measured: 60 days after surgery
Proctitis
The proportion of participants with clinical signs of active proctitis six months after surgery. Active proctitis will be assessed through rigid or flexible sigmoidoscopy and will be defined by the presence of any of the following findings: friable mucosa with edema, oozing, or ulcerations; bleeding; wall thickening; pseudopolyps; strictures; stenosis; loss of normal curvature; necrosis; perforations; fistula. The severity of proctitis will be classified using the RTOG/EORTC grading system
Measured: Six months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start30 Sep 2026 (estimated)
- Primary completion28 Feb 2028 (estimated)
- Study completion28 Feb 2028 (estimated)
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.
- More trials run by Istituto Clinico HumanitasThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonino Spinell, MD, PhD, Principal investigator, Department of Biomedical Sciences, Humanitas University, Via Rita Levi Montalcini 4, 20072 Pieve Emanuele, Milan, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07599501
- Sponsor's protocol ID
- CHR1-11-2025
- Acronym
- NUTRICOLOR
- Status last verified
- May 2026
- First submitted
- 4 May 2026
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: According to the Promoter Standard Operative Procedures, IPD will be uploaded in a public open-access repository (Zenodo). IPD will be made available upon request by sendind an email to biblioteca@humanitas.it
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Nutritional Supplementation to Prevent Postoperative Complications and Improve Postoperative Outcomes After Colorectal Cancer Surgery: a Single-center Unblinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07599501
- Acronym / sponsor ID
- NUTRICOLOR / CHR1-11-2025
- Conditions
- Colorectal Cancer, Colorectal Surgery
- Keywords
- Colorectal cancer, Colorectal surgery, Oral Nutritional Supplementation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 28 Feb 2028 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 20 May 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.
This study aims to explore the effectiveness of perioperative Oral Nutritional Supplementation (ONS) combined with an optimized, tailored diet in reducing the risk of postoperative complications and improving the nutritional status of colorectal cancer patients scheduled for curative colorectal resection.
Detailed description
The rate of postoperative complications after colorectal cancer surgery is around 35%. The preoperative nutritional status significantly influences the postoperative outcomes, and several studies have investigated the effect of perioperative nutritional interventions with mixed results. This study aims to explore the effect of perioperative Oral Nutritional Supplementation (ONS) on the postoperative outcomes of colorectal cancer patients receiving preoperative dietary optimization. Participants scheduled for elective curative colorectal cancer surgery will undergo a detailed preoperative nutritional screening and will be randomized to receive either an optimized diet alone or an optimized diet and perioperative ONS. Postoperative complications will be collected and registered until 60 days after surgery. The participants' nutritional status will be evaluated 60 days and 180 days after surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled
| Arm | Type | Receives |
|---|---|---|
| Diet optimization (DO) | Active comparator | Other: Diet Optimization (DO)Dietary optimization will include a tailored diet to maintain or restore a good nutritional status, body composition (e.g. weight or lean mass gain if necessary), and macro/micronutrient intake in case of deficiencies detected during the nutritional screening. Participants will be instructed to follow the dietary indications throughout the study, with appropriate adjustments according to following nutritional assessments. |
| Diet Optimization and Oral Nutritional Supplementation (DO+ONS) | Experimental | Other: Diet Optimization (DO), Dietary Supplement: Oral Nutritional Supplement (ONS)Participants in the DO+ONS arm will receive dietary optimization and standardized oral nutritional supplementation designed according to the ESPEN guidelines. The treatment will start 14 days before surgery and will be restored the day after surgery for the following 60 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Participants aged more than 18 years old.
- Histological diagnosis of colorectal adenocarcinoma.
- Participants scheduled for elective minimally invasive colorectal resection.
- Participants with a preoperative MUST score equal to or below 2. Exclusion criteria
- Any condition that, in the opinion of the investigator, may interfere with the study procedures.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Diet Optimization (DO)Dietary optimization will include a tailored diet to maintain or restore a good nutritional status, body composition (e.g. weight or lean mass gain if necessary), and macro/micronutrient intake in case of deficiencies detected during the nutritional screening. Participants will be instructed to follow the dietary indications throughout the study, with appropriate adjustments according to following nutritional assessments. | Other | Diet Optimization and Oral Nutritional Supplementation (DO+ONS), Diet optimization (DO) |
| Oral Nutritional Supplement (ONS)ONS will consist of LH Blu® (Lionhealth Italia Srl). LH Blu® is categorized as a food for special medical purposes and is indicated for the treatment of malnourished patients. ONS will start 14 days before the planned intervention with a tailored dosage decided according to the malnutrition risk (low vs medium). | Dietary supplement | Diet Optimization and Oral Nutritional Supplementation (DO+ONS) |
Primary outcome
Postoperative complications
Time frame: 30 days from surgery
The rate of postoperative complications occurring within 30 days from surgery
9 secondary outcomes
Postoperative septic complications
Time frame: 30 days from surgery
Comprehensive Complication Index (CCI)
Time frame: 30 days from surgery
Length of hospital stay
Time frame: 30 days from surgery
Hospital readmission
Time frame: 30 days from surgery
Sarcopenia
Time frame: Six months after surgery
Normal weight
Time frame: 60 days after surgery
Mini Nutritional Assessment (MNA) score
Time frame: 60 days after surgery
EuroQoL-5 Dimension- 5 Levels (EQ5D5L) score
Time frame: 60 days after surgery
Proctitis
Time frame: Six months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Individual participant dataSharing planned: No. According to the Promoter Standard Operative Procedures, IPD will be uploaded in a public open-access repository (Zenodo). IPD will be made available upon request by sendind an email to biblioteca@humanitas.it
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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.
Antonino Spinell, MD, PhD principal investigator
Department of Biomedical Sciences, Humanitas University, Via Rita Levi Montalcini 4, 20072 Pieve Emanuele, Milan, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet Optimization (DO) and Oral Nutritional Supplement (ONS) in people with Colorectal Cancer and Colorectal Surgery, run by Istituto Clinico Humanitas at 1 site in Italy.
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 10 inclusion and 0 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: opening soon, as of the sponsor's last update on 20 May 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Annalisa Maroli, PhD (00390282247776, annalisa.maroli@humanitas.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative complications (time frame: 30 days from surgery). 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 20 May 2026.