Peritoneal MetastasesNCT03430128
Perioperative Immunonutrition for Patients Undergoing CRS and HIPEC
A study testing IMPACT immunotherapy and ENSURE in people with Peritoneal Metastases, run by National Cancer Centre, Singapore at 1 site in Singapore.
Trial summary
Patients with peritoneal disease commonly present with symptoms of abdominal distension and subacute intestinal obstruction. This results in poor oral intake leading to these patients often presenting in a malnourished state. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Peritoneal Metastases
- What is being tested?
- IMPACT immunotherapy and ENSURE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSingapore
- Study dates
- 23 Apr 2017to 22 Jan 2019
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients planned for CRS and HIPEC, with sufficient time (5 to 7 days) prior to surgery for start of nutritional supplements are eligible
- All patients must be able to provide informed consent
- There are no restrictions to use of contraception
Who cannot join
- Patients who are not able to provide informed consent will be excluded.
- Patients with a diagnosis of diabetes mellitus will be excluded.
- Patients not fit for surgery or those who undergo surgery under emergency situations will be excluded.
- Patients who have intestinal obstruction and not able to consume the nutritional supplements orally will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Perioperative Immunonutrition for Patients Undergoing Cytoreductive Surgery (CRS) and Hyperthermic Intraperitoneal Chemotherapy
Patients with peritoneal disease commonly present with symptoms of abdominal distension and subacute intestinal obstruction. This results in poor oral intake leading to these patients often presenting in a malnourished state.
CRS and HIPEC can potential provide improve survival for these patients, however can be a hazardous procedure, involving multi-organ resections. The risk is especially high in poorly nourished patients.
The study investigators hypothesize that perioperative immunonutrition can reduce wound infections and length of hospital stay, and improve perioperative outcomes. To the investigators' knowledge, it has not been evaluated in patients undergoing CRS and HIPEC.
- Conditions
- Peritoneal Metastases
- Being tested
- IMPACT immunotherapy, ENSURE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMPACT immunotherapyDietary supplement
Powdered formula that is pre-packaged in individual packets which the patients will be instructed to mix with water before consumption.
ENSUREDietary supplement
Liquid milk formula available over the counter
| Study group | Role | What they receive |
|---|---|---|
| Oral IMPACT | Experimental | Perioperative immunonutrition will commence 5-7 days prior to surgery, and will continue for 5-7 days post-surgery, as soon as the patient is able to consume full feeds as instructed by his/her primary physician.
The recommended dose for IMPACT immunotherapy is one packet, to be taken three times a day. Receives: Dietary Supplement: IMPACT immunotherapy |
| Standard Nutrition (ENSURE) | Active comparator | Standard nutritional supplementation will commence 5-7 days prior to surgery, and will continue for 5-7 days post-surgery, as soon as the patient is able to consume full feeds as instructed by his/her primary physician. Receives: Dietary Supplement: ENSURE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline wound infection rates
Measured: From date of surgery to date that wound is healed, up to 30 days from surgery
Secondary outcomes (2)
Peri-operative complications
Measured: Within 30 days from surgery
Length of stay
Measured: 100 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2018
- Study start23 Apr 2017
- Primary completion22 Jan 2019
- Study completion22 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal MetastasesStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Centre, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melissa Teo, MD, Principal investigator, National Cancer Centre, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03430128
- Sponsor's protocol ID
- 2016/3063
- Status last verified
- Sep 2019
- First submitted
- 30 Jan 2018
- Last updated
- 20 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Immunonutrition for Patients Undergoing Cytoreductive Surgery (CRS) and Hyperthermic Intraperitoneal Chemotherapy
- ClinicalTrials.gov ID
- NCT03430128
- Acronym / sponsor ID
- 2016/3063
- Conditions
- Peritoneal Metastases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- National Cancer Centre, SingaporeUniversity, hospital or other
- Study start
- 23 Apr 2017 (actual)
- Primary completion
- 22 Jan 2019 (actual)
- Study completion
- 22 Jan 2019 (actual)
- First posted
- 12 Feb 2018 (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.
Patients with peritoneal disease commonly present with symptoms of abdominal distension and subacute intestinal obstruction. This results in poor oral intake leading to these patients often presenting in a malnourished state.
CRS and HIPEC can potential provide improve survival for these patients, however can be a hazardous procedure, involving multi-organ resections. The risk is especially high in poorly nourished patients.
The study investigators hypothesize that perioperative immunonutrition can reduce wound infections and length of hospital stay, and improve perioperative outcomes. To the investigators' knowledge, it has not been evaluated in patients undergoing CRS and HIPEC.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral IMPACT | Experimental | Dietary Supplement: IMPACT immunotherapyPerioperative immunonutrition will commence 5-7 days prior to surgery, and will continue for 5-7 days post-surgery, as soon as the patient is able to consume full feeds as instructed by his/her primary physician. The recommended dose for IMPACT immunotherapy is one packet, to be taken three times a day. |
| Standard Nutrition (ENSURE) | Active comparator | Dietary Supplement: ENSUREStandard nutritional supplementation will commence 5-7 days prior to surgery, and will continue for 5-7 days post-surgery, as soon as the patient is able to consume full feeds as instructed by his/her primary physician. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All patients planned for CRS and HIPEC, with sufficient time (5 to 7 days) prior to surgery for start of nutritional supplements are eligible
- All patients must be able to provide informed consent
- There are no restrictions to use of contraception
Key exclusion criteria (4 listed)
- Patients who are not able to provide informed consent will be excluded.
- Patients with a diagnosis of diabetes mellitus will be excluded.
- Patients not fit for surgery or those who undergo surgery under emergency situations will be excluded.
- Patients who have intestinal obstruction and not able to consume the nutritional supplements orally will be excluded.
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 immunotherapyPowdered formula that is pre-packaged in individual packets which the patients will be instructed to mix with water before consumption. | Dietary supplement | Oral IMPACT |
| ENSURELiquid milk formula available over the counter | Dietary supplement | Standard Nutrition (ENSURE) |
Primary outcome
Baseline wound infection rates
Time frame: From date of surgery to date that wound is healed, up to 30 days from surgery
2 secondary outcomes
Peri-operative complications
Time frame: Within 30 days from surgery
Length of stay
Time frame: 100 days
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 20 Sep 2019.
- Individual participant dataSharing planned: No
Related trials for Peritoneal Metastases
RecruitingPhase 1
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Peritoneal Mesothelioma, Peritoneal Carcinomatosis
RecruitingPhase 3
Pressurized Intraperitoneal Aerosolized Chemotherapy With Mitomycin for the Treatment of Unresectable Appendix or Colorectal Cancer With Peritoneal Metastases, The IMPACT Trial
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RecruitingPhase 3
A Three-Part Phase 3 Study of Sofetabart Mipitecan in Participants With Platinum-Resistant (Part A) and Platinum-Sensitive (Parts B and C) Ovarian Cancer
Ovarian Neoplasms, Fallopian Tube Neoplasms
RecruitingPhase 1
Intraperitoneal Paclitaxel With NALIRIFOX for Pancreatic Ductal Adenocarcinoma With Peritoneal Carcinomatosis
Pancreatic Ductal Adenocarcinoma (PDAC)
Not yet recruitingPhase 1
A Study of Mesothelin-Targeted CAR-Mix Cells in Patients With Advanced Solid Tumors
Mesothelin-Positive Advanced Solid Tumors With Peritoneal Metastasis
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.
Melissa Teo, MD principal investigator
National Cancer Centre, Singapore
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 immunotherapy and ENSURE in people with Peritoneal Metastases, run by National Cancer Centre, Singapore at 1 site in Singapore.
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 4 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 20 Sep 2019. 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 Singapore. 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?
Baseline wound infection rates (time frame: From date of surgery to date that wound is healed, up to 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 Sep 2019.