Rectal TumorsNCT00730808
Effectiveness and Tolerability of an Oral Nutritional Supplement (PreOP Booster) Given Before Surgery
A study testing PreOP Booster (food for special medical purposes) in people with Rectal Tumors, run by Fresenius Kabi at 1 site in Netherlands.
Trial summary
The aim of this pilot study is to investigate effectiveness, tolerability and safety of an oral nutritional supplement (PreOP Booster), given to rectal tumour patients prior to low anterior resection. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Tumors
- What is being tested?
- PreOP Booster (food for special medical purposes)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- Dec 2008to Nov 2009
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- rectal tumour with indication for elective low anterior resection (open surgery, not laparoscopic surgery) or abdominoperineal resection (APR)
- preoperative radiotherapy (5x5 Gy) or chemoradiation
- loop ileostoma or colostoma;
Who cannot join
- severe malnutrition
- severe renal insufficiency
- diabetes mellitus I or II
- concomitant thyroid medication
- corticosteroids
- diuretic medication and antihypertensive medication
- known or suspected allergy to any component of the investigational product(s)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Tolerability of a Preoperative Oral Nutritional Supplement (PreOP Booster) vs. Placebo in Surgical Patients (Pilot Study)
The aim of this pilot study is to investigate effectiveness, tolerability and safety of an oral nutritional supplement (PreOP Booster), given to rectal tumour patients prior to low anterior resection.
- Conditions
- Rectal Tumors
- Being tested
- PreOP Booster (food for special medical purposes)
- Keywords
- Enteral nutritional regimen prior to surgery
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PreOP Booster (food for special medical purposes)Dietary supplement
3x1 dosage is given prior to surgery: 2x1 the day prior to surgery; 1x1 3-4h prior to initiation of anaesthesia;
| Study group | Role | What they receive |
|---|---|---|
| Test | Experimental | Oral nutritional supplement: assignment according to consecutive random numbers. Receives: Dietary Supplement: PreOP Booster (food for special medical purposes) |
| Control | Placebo comparator | Assignment according to consecutive random numbers. Receives: Dietary Supplement: PreOP Booster (food for special medical purposes) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunoinflammatory parameters
Measured: on day -2, -1, 1, 2, 3, 5, and 7
Antioxidant / oxidant parameters
Measured: on day -2, 1, 3, 5, and 7
Ischemia / reperfusion injury parameters
Measured: on day -2, 1, 3, 5, and 7
Secondary outcomes (4)
pre-and postoperative discomfort (well-being)
Measured: on day -1, and 0
hand grip strength
Measured: on day -2, 1, 2, 3, 5, and 7
GI tolerance
Measured: on day -1, 0, 1, 2, and 7
Safety
Measured: on day -1, 0, 1, 2, 3, 5, and 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2008 (estimated)
- Study startDec 2008
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal TumorsStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fresenius Kabi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Paul A.M. van Leeuwen, Prof., Study chair, University Hospital Amsterdam; The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00730808
- Sponsor's protocol ID
- N-POB-04-NL
- Status last verified
- May 2010
- First submitted
- 5 Aug 2008
- Last updated
- 19 May 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Tolerability of a Preoperative Oral Nutritional Supplement (PreOP Booster) vs. Placebo in Surgical Patients (Pilot Study)
- ClinicalTrials.gov ID
- NCT00730808
- Acronym / sponsor ID
- N-POB-04-NL
- Conditions
- Rectal Tumors
- Keywords
- Enteral nutritional regimen prior to surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Fresenius KabiIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 8 Aug 2008 (estimated)
- 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.
The aim of this pilot study is to investigate effectiveness, tolerability and safety of an oral nutritional supplement (PreOP Booster), given to rectal tumour patients prior to low anterior resection.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test | Experimental | Dietary Supplement: PreOP Booster (food for special medical purposes)Oral nutritional supplement: assignment according to consecutive random numbers. |
| Control | Placebo comparator | Dietary Supplement: PreOP Booster (food for special medical purposes)Assignment according to consecutive random numbers. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- rectal tumour with indication for elective low anterior resection (open surgery, not laparoscopic surgery) or abdominoperineal resection (APR)
- preoperative radiotherapy (5x5 Gy) or chemoradiation
- loop ileostoma or colostoma;
Key exclusion criteria (7 listed)
- severe malnutrition
- severe renal insufficiency
- diabetes mellitus I or II
- concomitant thyroid medication
- corticosteroids
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 |
|---|---|---|
| PreOP Booster (food for special medical purposes)3x1 dosage is given prior to surgery: 2x1 the day prior to surgery; 1x1 3-4h prior to initiation of anaesthesia; | Dietary supplement | Control, Test |
Primary outcome
Immunoinflammatory parameters
Time frame: on day -2, -1, 1, 2, 3, 5, and 7
Antioxidant / oxidant parameters
Time frame: on day -2, 1, 3, 5, and 7
Ischemia / reperfusion injury parameters
Time frame: on day -2, 1, 3, 5, and 7
4 secondary outcomes
pre-and postoperative discomfort (well-being)
Time frame: on day -1, and 0
hand grip strength
Time frame: on day -2, 1, 2, 3, 5, and 7
GI tolerance
Time frame: on day -1, 0, 1, 2, and 7
Safety
Time frame: on day -1, 0, 1, 2, 3, 5, and 7
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 19 May 2010.
Related trials for Rectal Tumors
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
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.
Paul A.M. van Leeuwen, Prof. study chair
University Hospital Amsterdam; The Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PreOP Booster (food for special medical purposes) in people with Rectal Tumors, run by Fresenius Kabi at 1 site in Netherlands.
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: finished, as of the sponsor's last update on 19 May 2010. 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 Netherlands. 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. 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?
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?
Immunoinflammatory parameters (time frame: on day -2, -1, 1, 2, 3, 5, and 7). The study lists 3 primary outcomes in all. 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 19 May 2010.