Dietary and Nutritional TherapiesPhase 4SMOFPILOTNCT02539316
Pilot Study: Hepatoprotective Role of SMOFlipid® Used in Short-term Parenteral Nutrition in an Onco-Hematology Pediatric Population
A Phase 4 study testing Smoflipid and Médialipides in people with Dietary and Nutritional Therapies, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Parenteral nutrition (PN) is part of supportive care in oncology Pediatric when the patient's nutritional status justifies it and enteral is impossible. In the literature, hepatotoxicity, cholestasis type, standard emulsions of soy oil-based (type Médialipide®) is described in the context of a long-term PN especially… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Dietary and Nutritional Therapies
- What is being tested?
- Smoflipid and Médialipides
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2015to Oct 2016
- Phase
- Phase 4
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 0-18 years
- Solid Tumors
- hematological malignancies
- Requiring parenteral nutrition during at least 5 days
- With a central catheter
- With a normal hepatic function test
Who cannot join
- Liver function tests disrupted
- Patient with a tumor or liver metastases
- Patient with against-indication to the use of lipid
Trial locations and contacts
1 site in 1 country.
About this study
Parenteral nutrition (PN) is part of supportive care in oncology Pediatric when the patient's nutritional status justifies it and enteral is impossible. In the literature, hepatotoxicity, cholestasis type, standard emulsions of soy oil-based (type Médialipide®) is described in the context of a long-term PN especially in premature infants. It results in an increase in gammaGT. The most recent use of lipid emulsions containing Omega 3 (Smoflipid), was studied in the adult population and in the preterm in the PN on short and long, with the finding of a hepatoprotection. Investigators do not find a single retrospective study about it in Pediatric Onco-Hematology. No prospective studies have been performed in the population of Onco-Hematology. The objective of this study is to evaluate the impact of the use of SMOFlipid® in parenteral nutrition on early occurrence of cholestasis compared with Médialipides in a short-term use of parenteral nutrition in an Onco-Hematology pediatric population.
- Conditions
- Dietary and Nutritional Therapies
- Being tested
- Smoflipid, Médialipides
- Keywords
- Parenteral Nutrition
- Medical subject headings
- Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SmoflipidDrug
MédialipidesDrug
| Study group | Role | What they receive |
|---|---|---|
| Médialipides | Active comparator | parenteral nutrition by Médialipides (dosage form depending child's weight as recommended by the SPC) Receives: Drug: Médialipides |
| SmofLIPID | Experimental | parenteral nutrition by Smoflipid (dosage form depending child's weight as recommended by the SPC) Receives: Drug: Smoflipid |
What is being measured
The primary outcome is the main question the study is designed to answer.
dosage of γGT in UI/l
to evaluate the impact of the use of SMOFlipid® in parenteral nutrition on early occurrence of cholestasis compared with Médialipides in a short-term use of parenteral nutrition in an Onco-Hematology pediatric population.
Measured: Baseline
dosage of γGT in UI/l
Measured: at day 5
dosage of γGT in UI/l
Measured: 7 days after the end of parenteral nutrition
Secondary outcomes (12)
asat, alat, PAL, LDH, total bilirubin CRP
Measured: Baseline
asat, alat, PAL, LDH, total bilirubin CRP
Measured: at day 5
asat, alat, PAL, LDH, total bilirubin CRP
Measured: 7 days after the end of parenteral nutrition
Triglycerids Digestive tolerance (vomiting)
Measured: Baseline
Triglycerids Digestive tolerance (vomiting)
Measured: at day 5
Triglycerids Digestive tolerance (vomiting)
Measured: 7 days after the end of parenteral nutrition
Infectious episodes (numbers, duration)
Measured: Baseline
Infectious episodes (numbers, duration)
Measured: at day 5
Infectious episodes (numbers, duration)
Measured: 7 days after the end of parenteral nutrition
Nutritionnal status
(Albumin, weight, BMI)
Measured: Baseline
Nutritionnal status
(Albumin, weight, BMI)
Measured: at day 5
Nutritionnal status
(Albumin, weight, BMI)
Measured: 7 days after the end of parenteral nutrition
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2015 (estimated)
- Study startJun 2015
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary and Nutritional TherapiesStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02539316
- Sponsor's protocol ID
- 15-PP-03
- Acronym
- SMOFPILOT
- Status last verified
- Apr 2017
- First submitted
- 11 Aug 2015
- Last updated
- 13 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: Hepatoprotective Role of SMOFlipid® Used in Short-term Parenteral Nutrition in an Onco-Hematology Pediatric Population
- ClinicalTrials.gov ID
- NCT02539316
- Acronym / sponsor ID
- SMOFPILOT / 15-PP-03
- Conditions
- Dietary and Nutritional Therapies
- Keywords
- Parenteral Nutrition
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 3 Sep 2015 (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.
Parenteral nutrition (PN) is part of supportive care in oncology Pediatric when the patient's nutritional status justifies it and enteral is impossible. In the literature, hepatotoxicity, cholestasis type, standard emulsions of soy oil-based (type Médialipide®) is described in the context of a long-term PN especially in premature infants. It results in an increase in gammaGT. The most recent use of lipid emulsions containing Omega 3 (Smoflipid), was studied in the adult population and in the preterm in the PN on short and long, with the finding of a hepatoprotection. Investigators do not find a single retrospective study about it in Pediatric Onco-Hematology. No prospective studies have been performed in the population of Onco-Hematology. The objective of this study is to evaluate the impact of the use of SMOFlipid® in parenteral nutrition on early occurrence of cholestasis compared with Médialipides in a short-term use of parenteral nutrition in an Onco-Hematology pediatric population.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Médialipides | Active comparator | Drug: Médialipidesparenteral nutrition by Médialipides (dosage form depending child's weight as recommended by the SPC) |
| SmofLIPID | Experimental | Drug: Smoflipidparenteral nutrition by Smoflipid (dosage form depending child's weight as recommended by the SPC) |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 0-18 years
- Solid Tumors
- hematological malignancies
- Requiring parenteral nutrition during at least 5 days
- With a central catheter
Key exclusion criteria (3 listed)
- Liver function tests disrupted
- Patient with a tumor or liver metastases
- Patient with against-indication to the use of lipid
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 |
|---|---|---|
| Smoflipid | Drug | SmofLIPID |
| Médialipides | Drug | Médialipides |
Primary outcome
dosage of γGT in UI/l
Time frame: Baseline
to evaluate the impact of the use of SMOFlipid® in parenteral nutrition on early occurrence of cholestasis compared with Médialipides in a short-term use of parenteral nutrition in an Onco-Hematology pediatric population.
dosage of γGT in UI/l
Time frame: at day 5
dosage of γGT in UI/l
Time frame: 7 days after the end of parenteral nutrition
12 secondary outcomes
asat, alat, PAL, LDH, total bilirubin CRP
Time frame: Baseline
asat, alat, PAL, LDH, total bilirubin CRP
Time frame: at day 5
asat, alat, PAL, LDH, total bilirubin CRP
Time frame: 7 days after the end of parenteral nutrition
Triglycerids Digestive tolerance (vomiting)
Time frame: Baseline
Triglycerids Digestive tolerance (vomiting)
Time frame: at day 5
Triglycerids Digestive tolerance (vomiting)
Time frame: 7 days after the end of parenteral nutrition
Infectious episodes (numbers, duration)
Time frame: Baseline
Infectious episodes (numbers, duration)
Time frame: at day 5
Infectious episodes (numbers, duration)
Time frame: 7 days after the end of parenteral nutrition
Nutritionnal status
Time frame: Baseline
Nutritionnal status
Time frame: at day 5
Nutritionnal status
Time frame: 7 days after the end of parenteral nutrition
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 13 Apr 2017.
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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 Phase 4 study testing Smoflipid and Médialipides in people with Dietary and Nutritional Therapies, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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 6 inclusion and 3 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 13 Apr 2017. 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 France. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
dosage of γGT in UI/l (time frame: Baseline). 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 13 Apr 2017.