Colorectal AdenocarcinomaINCASNCT06134440
ImmunoNutrition and Colorectal Adenocarcinoma Surgery - INCAS Study
A study testing Impact Oral® in people with Colorectal Adenocarcinoma, run by Istituto Oncologico Veneto IRCCS at 1 site in Italy.
Trial summary
Compared to upper gastrointestinal (GI) malignancies, CRC patients generally present with satisfactory nutritional status at surgery and malnutrition is typically present in advanced stages of CRC. Therefore, in the latter surgery may not be offered with curative intent. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Adenocarcinoma
- What is being tested?
- Impact Oral®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteItaly
- Study dates
- 21 Nov 2023to 25 Feb 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 aged ≥ 18 years or older;
- histologically confirmed adenocarcinoma of colon or rectum;
- Eligible for elective curative surgery with indication of colon and/or rectal resection in laparoscopy with mini-invasive technique;
- eligible for ERAS protocol;
- Written informed consent to the study participation according to the Local Ethic Committee requirements before any study procedure;
Who cannot join
- colon or rectal resection for benign disease;
- TNM Stage ≥4;
- neoadjuvant radio and/or chemotherapy
- ASA score > 3;
- contraindications to oral nutrition (e.g. dysphagia, pyloric stenosis) or hypersensitivity to any ingredient of study product;
- albuminemia < 3.0 g/l;
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- weight loss > 10% in the last 3-6 months;
- BMI < 18.5 kg/m2;
- pregnant or breastfeeding;
- Not self-sufficient or with poor family compliance;
- Congenital or acquired immunodeficiency;
- Active uncontrolled pre-operative infections or other clinically relevant concomitant illness that preclude laparoscopic procedure;
- Bowel obstruction or parenteral nutrition or gastric tube;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ImmunoNutrition and Colorectal Adenocarcinoma Surgery: a Randomized Study. INCAS Study
Compared to upper gastrointestinal (GI) malignancies, CRC patients generally present with satisfactory nutritional status at surgery and malnutrition is typically present in advanced stages of CRC. Therefore, in the latter surgery may not be offered with curative intent. Based on the current evidence, the role of OIN appears to be consolidated for malnourished patients undergoing surgery for gastrointestinal cancer. Regarding not malnourished patients, there is still no clear correlation between OIN and decrease in post-operative complications. Furthermore, whether OIN increases immune response within the tumour microenvironment is based on studies with poor number of patients.
Read the detailed description
Randomized, controlled, open-label, single-centre study in patients candidate for elective curative surgery for colon-rectal cancer.
The study intervention consists of the oral nutritional supplementation enriched with immune-nutrients delivered before and after surgery in addition to standard dietary advice according to E.R.A.S. protocol.
All patients will follow low-fiber diet according to ERAS protocol during the study period. Patients assigned to the experimental arm will assume also Impact Oral®, an oral nutritional supplement with immune-nutrients (hyper-proteic formula), manufactured and commercialized by Nestlé Health Science S.p.a. It is a liquid drink packaged in a brick of 237 ml. Patients will assume Impact Oral® for 5 days before surgery and 5 day after surgery.
- Conditions
- Colorectal Adenocarcinoma
- Being tested
- Impact Oral®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Impact Oral®Dietary supplement
All patients will follow low-fiber diet according to ERAS protocol during the study period. Patients assigned to the experimental arm will assume also Impact Oral®, an oral nutritional supplement with immune-nutrients (hyper-proteic formula), manufactured and commercialized by Nestlé Health Science S.p.a. It is a liquid drink packaged in a brick of 237 ml. Patients will assume Impact Oral® for 5 days before surgery and 5 day after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Arm A (interventional arm) | Experimental | a low-fiber dietary advice + oral nutritional supplement enriched with immune-nutrients for 5 pre-operative days and 5 post-operative days. Receives: Dietary Supplement: Impact Oral® |
| Arm B (control arm) | No intervention | a low fiber dietary advice only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome Measure - Number of patients with grade 2 or higher post-operative complications
Number of patients with grade 2 or higher post-operative complications according to Clavien-Dindo classification occurred within 30 days post-surgical intervention.
Measured: within 30 days post-surgical intervention
Secondary outcomes (7)
Secondary Outcome Measure - Hospital length of stay
Hospital length of stay defined as hospitalization from the day of surgery until discharge
Measured: From the day of surgery until discharge, assessed up to 7 days
Secondary Outcome Measure - Reoperation rate
Reoperation rate within 30 days from index surgery defined as any unplanned post-operative procedure including a return in the operating room or an imaging-guided intervention within 30 days following the index surgery
Measured: within 30 days following the index surgery
Secondary Outcome Measure - Unplanned readmissions
Unplanned readmissions within 30 days from discharge
Measured: within 30 days from discharge
Secondary Outcome Measure - 30-day mortality for any cause
30-day mortality for any cause
Measured: 30-day mortality for any cause
Secondary Outcome Measure - Safety assessed according to CTCAE
Safety assessed according to criteria to NCI Common Toxicity Criteria Adverse Event (CTCAE), version 5
Measured: From admission to discharge, assessed up to 42 days
Secondary Outcome Measure - Nutritional status before and after surgery
Nutritional status before and after surgery will be assessed evaluating albumin, prealbumin and transferrin serum levels: differences at day 1, 3, 5, 15 and 30 after surgery from T0 (7-10 days before surgery) will be calculated and compared between the two arms
Measured: differences at day 1, 3, 5, 15 and 30 after surgery from T0 (7-10 days before surgery) will be calculated and compared between the two arms
Secondary Outcome Measure - Inflammatory status before and after surgery
Inflammatory status before and after surgery will be assessed evaluating leukocytes (x10^(9)/L), C-reactive protein (PCR) (mg/dL), procalcitonin (ug/L), neutrophil-lymphocyte (ratio), and lactate dehydrogenase (LDH) serum levels (U/L).
The haematic quantification of this biomarkers provides information about the inflammatory status.
Measured: differences at day 1, 3, 5, 15 and 30 after surgery from T0 (7-10 days before surgery) will be calculated and compared between the two arms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start21 Nov 2023
- Primary completion9 Sep 2025
- Study completion25 Feb 2026
Why it stopped: problems encountered during the patient recruitment phase which led to the pre-established recruitment objectives not being met.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal AdenocarcinomaStudies 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
- Model description
- Randomized, controlled, open-label, single-centre study in patients candidate to elective curative surgery for colon-rectal cancer.
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Oncologico Veneto IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06134440
- Sponsor's protocol ID
- IOV-CRC-01-2022 INCAS
- Acronym
- INCAS
- Status last verified
- Mar 2026
- First submitted
- 7 Nov 2023
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ImmunoNutrition and Colorectal Adenocarcinoma Surgery: a Randomized Study. INCAS Study
- ClinicalTrials.gov ID
- NCT06134440
- Acronym / sponsor ID
- INCAS / IOV-CRC-01-2022 INCAS
- Conditions
- Colorectal Adenocarcinoma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: problems encountered during the patient recruitment phase which led to the pre-established recruitment objectives not being met.
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Istituto Oncologico Veneto IRCCSUniversity, hospital or other
- Study start
- 21 Nov 2023 (actual)
- Primary completion
- 9 Sep 2025 (actual)
- Study completion
- 25 Feb 2026 (actual)
- First posted
- 18 Nov 2023 (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.
Compared to upper gastrointestinal (GI) malignancies, CRC patients generally present with satisfactory nutritional status at surgery and malnutrition is typically present in advanced stages of CRC. Therefore, in the latter surgery may not be offered with curative intent. Based on the current evidence, the role of OIN appears to be consolidated for malnourished patients undergoing surgery for gastrointestinal cancer. Regarding not malnourished patients, there is still no clear correlation between OIN and decrease in post-operative complications. Furthermore, whether OIN increases immune response within the tumour microenvironment is based on studies with poor number of patients.
Detailed description
Randomized, controlled, open-label, single-centre study in patients candidate for elective curative surgery for colon-rectal cancer.
The study intervention consists of the oral nutritional supplementation enriched with immune-nutrients delivered before and after surgery in addition to standard dietary advice according to E.R.A.S. protocol.
All patients will follow low-fiber diet according to ERAS protocol during the study period. Patients assigned to the experimental arm will assume also Impact Oral®, an oral nutritional supplement with immune-nutrients (hyper-proteic formula), manufactured and commercialized by Nestlé Health Science S.p.a. It is a liquid drink packaged in a brick of 237 ml. Patients will assume Impact Oral® for 5 days before surgery and 5 day after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, controlled, open-label, single-centre study in patients candidate to elective curative surgery for colon-rectal cancer.
| Arm | Type | Receives |
|---|---|---|
| Arm A (interventional arm) | Experimental | Dietary Supplement: Impact Oral®a low-fiber dietary advice + oral nutritional supplement enriched with immune-nutrients for 5 pre-operative days and 5 post-operative days. |
| Arm B (control arm) | No intervention | –a low fiber dietary advice only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged ≥ 18 years or older;
- histologically confirmed adenocarcinoma of colon or rectum;
- Eligible for elective curative surgery with indication of colon and/or rectal resection in laparoscopy with mini-invasive technique;
- eligible for ERAS protocol;
- Written informed consent to the study participation according to the Local Ethic Committee requirements before any study procedure;
Key exclusion criteria (13 listed)
- colon or rectal resection for benign disease;
- TNM Stage ≥4;
- neoadjuvant radio and/or chemotherapy
- ASA score > 3;
- contraindications to oral nutrition (e.g. dysphagia, pyloric stenosis) or hypersensitivity to any ingredient of study product;
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 |
|---|---|---|
| Impact Oral®All patients will follow low-fiber diet according to ERAS protocol during the study period. Patients assigned to the experimental arm will assume also Impact Oral®, an oral nutritional supplement with immune-nutrients (hyper-proteic formula), manufactured and commercialized by Nestlé Health Science S.p.a. It is a liquid drink packaged in a brick of 237 ml. Patients will assume Impact Oral® for 5 days before surgery and 5 day after surgery. | Dietary supplement | Arm A (interventional arm) |
Primary outcome
Primary Outcome Measure - Number of patients with grade 2 or higher post-operative complications
Time frame: within 30 days post-surgical intervention
Number of patients with grade 2 or higher post-operative complications according to Clavien-Dindo classification occurred within 30 days post-surgical intervention.
7 secondary outcomes
Secondary Outcome Measure - Hospital length of stay
Time frame: From the day of surgery until discharge, assessed up to 7 days
Secondary Outcome Measure - Reoperation rate
Time frame: within 30 days following the index surgery
Secondary Outcome Measure - Unplanned readmissions
Time frame: within 30 days from discharge
Secondary Outcome Measure - 30-day mortality for any cause
Time frame: 30-day mortality for any cause
Secondary Outcome Measure - Safety assessed according to CTCAE
Time frame: From admission to discharge, assessed up to 42 days
Secondary Outcome Measure - Nutritional status before and after surgery
Time frame: differences at day 1, 3, 5, 15 and 30 after surgery from T0 (7-10 days before surgery) will be calculated and compared between the two arms
Secondary Outcome Measure - Inflammatory status before and after surgery
Time frame: differences at day 1, 3, 5, 15 and 30 after surgery from T0 (7-10 days before surgery) will be calculated and compared between the two arms
Results and safety
The study was stopped early (reason given: problems encountered during the patient recruitment phase which led to the pre-established recruitment objectives not being met.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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 Impact Oral® in people with Colorectal Adenocarcinoma, run by Istituto Oncologico Veneto IRCCS 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 5 inclusion and 13 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: stopped early, as of the sponsor's last update on 27 Mar 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?
The study was stopped early (reason given: problems encountered during the patient recruitment phase which led to the pre-established recruitment objectives not being met.). Results are not available in the source record.
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?
Primary Outcome Measure - Number of patients with grade 2 or higher post-operative complications (time frame: within 30 days post-surgical intervention). 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 27 Mar 2026.