Cancer of ColonNCT05916001
Preoperative Immunonutrition in Patients Undergoing Elective Colorectal Surgery for Neoplasm
A study testing Oral Impact Nestle and Colorectal surgery in people with Cancer of Colon and Nutrition Related Cancer, run by University of Roma La Sapienza.
Trial summary
Enhanced Recovery After Surgery (ERAS) protocols were developed to standardize perioperative practice in colon surgery to reduce morbidity, improve recovery, and shorten length of stay (LOS). Better protocol adherence translates into fewer readmissions and complications, and better 5-year survival. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Cancer of Colon, Nutrition Related Cancer
- What is being tested?
- Oral Impact Nestle and Colorectal surgery
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 216 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2023to 31 Oct 2025
- 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 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- primary colorectal neoplasms eligible for elective surgery, undergoing minivasive resections.
- 20 to 85 years old, with no difficulties in oral intake
- BMI ranging from 18 to 40.
Who cannot join
- emergency surgery,
- converted procedures,
- major intraoperative complications,
- concomitant chronic disease such as chronic renal failure, rheumatic and hematological disease, chronic inflammatory bowel diseases,
- synchronous cancer,
- previous bowel resections or bariatric surgery,
- presence of preoperative stoma.
About this study
Official title: Multicenter RCT on Effects of Preoperative Immunonutrition on Patients Undergoing Elective Colorectal Surgery for Neoplasm: Changes in Adipose Tissue Inflammation and Correlation With Surgical Outcome for Future ERAS Guidelines.
Enhanced Recovery After Surgery (ERAS) protocols were developed to standardize perioperative practice in colon surgery to reduce morbidity, improve recovery, and shorten length of stay (LOS). Better protocol adherence translates into fewer readmissions and complications, and better 5-year survival. Preoperative elements, especially nutrition and immunonutrition, are topics that need further development to become the standard of care. It has been widely reported that the prevalence of malnutrition reaches 40% in cancer patients at the time of diagnosis. Impaired nutritional status at the time of surgery and cancer-induced inflammation, along with postoperative inflammatory responses to major surgery, increase the risk of postoperative complications, along with a decrease in perceived quality of life.
Immunonutrition can modulate inflammation and reduce postoperative infections and shorten length of stay by counteracting the immune response induced by cancer. Adipose tissue has been shown to be a relevant source of inflammatory mediators, which may play a role in the promotion of tumor cachexia.
The present study is a multicenter randomized control study (RCT) designed to evaluate the effect of preoperative immunonutrition in patients with colorectal cancer eligible for elective minimally invasive procedures, evaluating in particular surgical site infection and length of hospital stay. A biopsy of subcutaneous adipose tissue and visceral adipose tissue will also be performed, in order to evaluate the differences between inflammatory infiltrate, degree of fibrosis and cross-sectional area of adipocytes compared to controls.
- Conditions
- Cancer of Colon, Nutrition Related Cancer
- Being tested
- Placebo, Oral Impact Nestle, Colorectal surgery
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
A Placebo will be administered per os 3 times per day for 10 days before colorectal surgery
Oral Impact NestleDietary supplement
Oral Impact Nestle will be administered per os 3 times per day for 10 days before colorectal surgery
Colorectal surgeryProcedure or surgery
Colorectal surgery will include right colectomy, left colectomy, transverse colectomy, anterior rectal resection. All procedures will be performed according to the standard clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| A, Impact oral + Colorectal Surgery | Active comparator | the supplement Oral Impact will be administered 3 times a day for 10 days before the operation.
Colon surgery will be performed according to standard clinical practice. Receives: Dietary Supplement: Oral Impact Nestle; Procedure: Colorectal surgery |
| B, Placebo group + Colorectal Surgery | Placebo comparator | A Placebo will be administered 3 times a day for 10 days before the operation. Colon surgery will be performed according to standard clinical practice. Receives: Other: Placebo; Procedure: Colorectal surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical site infection (SSI)
Number of participants developing surgical site infections (SSI), defined as wound/parietal infection or intra-abdominal abscess without any anastomotic leak.
Measured: 30 days after the surgical procedure
Secondary outcomes (5)
Anastomotic leakage (AL)
Number of participants developing anastomotic leakage (AL), defined as the evidence of leakage at the ileocolic or colo-colic or colo-rectal anastomosis, diagnosed with imaging modalities or with reoperation
Measured: 30 days after the surgical procedure
Length of stay (LOS)
Mean and Median Length of stay (LOS), defined as the mean and median number of days of hospitalization from the day of the surgical procedure to the day of patients' discharge
Measured: at patients' discharge
Inflammatory infiltration in the subcutaneous adipose tissue (SAT) and visceral adipose tissue (VAT)
Number of inflammatory cells in the specimens of subcutaneous adipose tissue (SAT) and visceral adipose tissue (VAT), as stated in a previous study published by the investigators (Molfino A, J Cachexia Sarcopenia Muscle. 2022 Feb;13(1):333-342.).
Measured: at the time of tissue analysis, usually 1 month after surgery
grade of fibrosis in the subcutaneous adipose tissue (SAT) and visceral adipose tissue (VAT)
Number of fibroblasts in the specimens of subcutaneous adipose tissue (SAT) and visceral adipose tissue (VAT), as stated in a previous study published by the investigators (Molfino A, J Cachexia Sarcopenia Muscle. 2022 Feb;13(1):333-342.).
Measured: at the time of tissue analysis, usually 1 month after surgery
Adipocytes cross sectional area (CSA) in the subcutaneous adipose tissue (SAT) and visceral adipose tissue (VAT)
Adipocytes cross sectional area (CSA) in the specimens of subcutaneous adipose tissue (SAT) and visceral adipose tissue (VAT), as stated in a previous study published by the investigators (Molfino A, J Cachexia Sarcopenia Muscle. 2022 Feb;13(1):333-342.).
Measured: at the time of tissue analysis, usually 1 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start1 Jul 2023 (estimated)
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of ColonStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe Nigri, MD, PhD, FACS, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05916001
- Sponsor's protocol ID
- 7064/2023
- Status last verified
- Jun 2023
- First submitted
- 15 Mar 2023
- Last updated
- 23 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter RCT on Effects of Preoperative Immunonutrition on Patients Undergoing Elective Colorectal Surgery for Neoplasm: Changes in Adipose Tissue Inflammation and Correlation With Surgical Outcome for Future ERAS Guidelines.
- ClinicalTrials.gov ID
- NCT05916001
- Acronym / sponsor ID
- 7064/2023
- Conditions
- Cancer of Colon, Nutrition Related Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 23 Jun 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.
Enhanced Recovery After Surgery (ERAS) protocols were developed to standardize perioperative practice in colon surgery to reduce morbidity, improve recovery, and shorten length of stay (LOS). Better protocol adherence translates into fewer readmissions and complications, and better 5-year survival. Preoperative elements, especially nutrition and immunonutrition, are topics that need further development to become the standard of care. It has been widely reported that the prevalence of malnutrition reaches 40% in cancer patients at the time of diagnosis. Impaired nutritional status at the time of surgery and cancer-induced inflammation, along with postoperative inflammatory responses to major surgery, increase the risk of postoperative complications, along with a decrease in perceived quality of life.
Immunonutrition can modulate inflammation and reduce postoperative infections and shorten length of stay by counteracting the immune response induced by cancer. Adipose tissue has been shown to be a relevant source of inflammatory mediators, which may play a role in the promotion of tumor cachexia.
The present study is a multicenter randomized control study (RCT) designed to evaluate the effect of preoperative immunonutrition in patients with colorectal cancer eligible for elective minimally invasive procedures, evaluating in particular surgical site infection and length of hospital stay. A biopsy of subcutaneous adipose tissue and visceral adipose tissue will also be performed, in order to evaluate the differences between inflammatory infiltrate, degree of fibrosis and cross-sectional area of adipocytes compared to controls.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A, Impact oral + Colorectal Surgery | Active comparator | Dietary Supplement: Oral Impact Nestle, Procedure: Colorectal surgerythe supplement Oral Impact will be administered 3 times a day for 10 days before the operation. Colon surgery will be performed according to standard clinical practice. |
| B, Placebo group + Colorectal Surgery | Placebo comparator | Other: Placebo, Procedure: Colorectal surgeryA Placebo will be administered 3 times a day for 10 days before the operation. Colon surgery will be performed according to standard clinical practice. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- primary colorectal neoplasms eligible for elective surgery, undergoing minivasive resections.
- 20 to 85 years old, with no difficulties in oral intake
- BMI ranging from 18 to 40.
Key exclusion criteria (7 listed)
- emergency surgery,
- converted procedures,
- major intraoperative complications,
- concomitant chronic disease such as chronic renal failure, rheumatic and hematological disease, chronic inflammatory bowel diseases,
- synchronous cancer,
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 |
|---|---|---|
| PlaceboA Placebo will be administered per os 3 times per day for 10 days before colorectal surgery | Other | B, Placebo group + Colorectal Surgery |
| Oral Impact NestleOral Impact Nestle will be administered per os 3 times per day for 10 days before colorectal surgery | Dietary supplement | A, Impact oral + Colorectal Surgery |
| Colorectal surgeryColorectal surgery will include right colectomy, left colectomy, transverse colectomy, anterior rectal resection. All procedures will be performed according to the standard clinical practice. | Procedure or surgery | A, Impact oral + Colorectal Surgery, B, Placebo group + Colorectal Surgery |
Primary outcome
Surgical site infection (SSI)
Time frame: 30 days after the surgical procedure
Number of participants developing surgical site infections (SSI), defined as wound/parietal infection or intra-abdominal abscess without any anastomotic leak.
5 secondary outcomes
Anastomotic leakage (AL)
Time frame: 30 days after the surgical procedure
Length of stay (LOS)
Time frame: at patients' discharge
Inflammatory infiltration in the subcutaneous adipose tissue (SAT) and visceral adipose tissue (VAT)
Time frame: at the time of tissue analysis, usually 1 month after surgery
grade of fibrosis in the subcutaneous adipose tissue (SAT) and visceral adipose tissue (VAT)
Time frame: at the time of tissue analysis, usually 1 month after surgery
Adipocytes cross sectional area (CSA) in the subcutaneous adipose tissue (SAT) and visceral adipose tissue (VAT)
Time frame: at the time of tissue analysis, usually 1 month after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2023.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Impact Nestle and Colorectal surgery in people with Cancer of Colon and Nutrition Related Cancer, run by University of Roma La Sapienza.
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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 23 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
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?
Surgical site infection (SSI) (time frame: 30 days after the surgical procedure). 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 23 Jun 2023.