ColitisPhase 2LUNCH1NCT00533078
Lipid Use, Nutrition, and Colitis in Patients With Hematological Malignancies
A Phase 2 study testing omegaven in people with Colitis and Mucositis, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
In patients with acute myelogenous leukemia (AML), a high proportion will suffer from inflammation of the large bowel (colitis) during their intensive treatment. As there is no standard treatment available for this potentially lifethreatening condition, the investigators focus on the role of parenteral nutrition which… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- omegaven
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2007to Dec 2009
- Phase
- Phase 2
- 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
- All of the following:
- Subjects with a cyto- or histopathologically confirmed diagnosis of newly diagnosed:
- AML or
- biphenotypic acute leukemia with predominantly myeloid features undergoing myeloablative treatment analogous to AML or
- refractory anemia with excess of blasts (RAEB) or refractory anemia with excess of blasts in transformation (RAEB-t) with an IPSS score of >1.5 (appendix 10.8.) and
- ECOG performance status (PS) £2 (see appendix 10.2.) and
- Written informed consent
Who cannot join
- One or more of the following:
- Contraindication to myeloablative chemotherapy, intravenous lipids, or TPN
- Previous or concomitant chronic inflammatory bowel disease, unspecified colitis or pancreatitis
- Impaired hepatic or renal function as defined by:
- ALAT and/or ASAT >3 x upper normal limit (UNL) and/or Bilirubin >3 x UNL unless increase is most likely caused by AML organ infiltration
- Serum creatinin >3 x UNL (after adequate hydration), unless increase is most likely caused by AML organ infiltration
- Other concurrent severe and/or uncontrolled medical condition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lipid Use, Nutrition, and Colitis in Patients With Hematological Malignancies (LUNCH1)
In patients with acute myelogenous leukemia (AML), a high proportion will suffer from inflammation of the large bowel (colitis) during their intensive treatment. As there is no standard treatment available for this potentially lifethreatening condition, the investigators focus on the role of parenteral nutrition which these patients inevitably require. Preclinical and clinical data have shown strong anti-inflammatory properties of fish oil preparations containing poly-unsaturated omega3 fatty acids (PUFA) as opposed to other lipid fractions. There may be a therapeutic benefit of adding omega3 PUFA to standard nutrition in patients with chemotherapy-induced colitis. In this small phase II study, the investigators address the effectiveness of this approach to reduce the incidence and severity of colitis in AML patients.
Read the detailed description
Experimental and clinical data attribute multiple anti-inflammatory effects to a diet enriched in omega-3 PUFA containing oils, mainly FO. These effects are mediated by their active metabolites, the EPA- and DHA-derived eicosanoids, which antagonize the predominantly pro-inflammatory derivates of omega-6 PUFA origin. In cardiovascular disease these data are supported by several large-scale trials, but there also is growing evidence of beneficial effects of an omega-3 PUFA rich diet in GI conditions such as postoperative trauma and inflammatory bowel disease. AML patients with neutropenic colitis suffer from a condition which is pathophysiologically closely related to the studied diseases. It is therefore reasonable to raise the question whether this cohort would equally benefit from a novel nutritional regimen enriched in omega-3 PUFA.
The proposed pilot study will address the question of the clinical value of adding an omega-3 PUFA containing lipid emulsion to the TPN regimen as regards protection against colitis ≥ °3 (primary objective). A numerical cutoff will be provided to support the decision whether further investigation is warranted or the intervention is considered not promising.
Target accrual is n=35 patients receiving TPN. An interim analysis will be performed after n1=13 patients will be evaluable for the primary endpoint. The results of this interim analysis will determine whether continuation of the trial is of interest or the trial be stopped. The sample size has been calculated by the use of Simon's two-stage minimax design.
- Being tested
- omegaven
- Keywords
- omega3 fatty acid, parenteral nutrition, chemotherapy, infection, neutropenia
- Medical subject headings
- Colitis, Mucositis, Hyperphagia, Infections, Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
omegavenDietary supplement
Trial participants are prescribed TPN by the attending physician as soon as indicated, which will be administered via a central venous line over a time period of approximately 20 hours per day. The formulation given to all patients is Nutriflex lipid spezial®, an emulsion containing the full supply of carbohydrates, amino acids and lipids (SO:MCT = 1:1) with a total energy content of 2215 kcal in a 1875 ml volume, see Investigator's Brochure. In addition, they receive daily infusional Omegaven® 100 ml over 4 hours, which equal FO 10 g/d or omega-3 PUFA 3-6 g/d.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Not described Receives: Dietary Supplement: omegaven |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy of an omega-3 PUFA containing lipid emulsion in reducing the incidence of °3-4 colitis (CTC AE v3.0)
Measured: time to completion of cytotoxic chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2007 (estimated)
- Study startNov 2007
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ColitisStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe 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 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Investigators
- Johannes Bükki, MD, Principal investigator, Inselspital Berne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00533078
- Sponsor's protocol ID
- 2007DR2232
- Other IDs
- 1345 (institution), 120/07 (ethics review board)
- Acronym
- LUNCH1
- Status last verified
- Jul 2015
- First submitted
- 19 Sep 2007
- Last updated
- 23 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Bukki J, Stanga Z, Tellez FB, Duclos K, Kolev M, Krahenmann P, Pabst T, Iff S, Juni P. Omega-3 poly-unsaturated fatty acids for the prevention of severe neutropenic enterocolitis in patients with acute myeloid leukemia. Nutr Cancer. 2013;65(6):834-42. doi: 10.1080/01635581.2013.801998.
PubMed 23909727
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lipid Use, Nutrition, and Colitis in Patients With Hematological Malignancies (LUNCH1)
- ClinicalTrials.gov ID
- NCT00533078
- Acronym / sponsor ID
- LUNCH1 / 2007DR2232
- Keywords
- omega3 fatty acid, parenteral nutrition, chemotherapy, infection, neutropenia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 21 Sep 2007 (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.
In patients with acute myelogenous leukemia (AML), a high proportion will suffer from inflammation of the large bowel (colitis) during their intensive treatment. As there is no standard treatment available for this potentially lifethreatening condition, the investigators focus on the role of parenteral nutrition which these patients inevitably require. Preclinical and clinical data have shown strong anti-inflammatory properties of fish oil preparations containing poly-unsaturated omega3 fatty acids (PUFA) as opposed to other lipid fractions. There may be a therapeutic benefit of adding omega3 PUFA to standard nutrition in patients with chemotherapy-induced colitis. In this small phase II study, the investigators address the effectiveness of this approach to reduce the incidence and severity of colitis in AML patients.
Detailed description
Experimental and clinical data attribute multiple anti-inflammatory effects to a diet enriched in omega-3 PUFA containing oils, mainly FO. These effects are mediated by their active metabolites, the EPA- and DHA-derived eicosanoids, which antagonize the predominantly pro-inflammatory derivates of omega-6 PUFA origin. In cardiovascular disease these data are supported by several large-scale trials, but there also is growing evidence of beneficial effects of an omega-3 PUFA rich diet in GI conditions such as postoperative trauma and inflammatory bowel disease. AML patients with neutropenic colitis suffer from a condition which is pathophysiologically closely related to the studied diseases. It is therefore reasonable to raise the question whether this cohort would equally benefit from a novel nutritional regimen enriched in omega-3 PUFA.
The proposed pilot study will address the question of the clinical value of adding an omega-3 PUFA containing lipid emulsion to the TPN regimen as regards protection against colitis ≥ °3 (primary objective). A numerical cutoff will be provided to support the decision whether further investigation is warranted or the intervention is considered not promising.
Target accrual is n=35 patients receiving TPN. An interim analysis will be performed after n1=13 patients will be evaluable for the primary endpoint. The results of this interim analysis will determine whether continuation of the trial is of interest or the trial be stopped. The sample size has been calculated by the use of Simon's two-stage minimax design.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Dietary Supplement: omegaven |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- All of the following:
- AML or
- biphenotypic acute leukemia with predominantly myeloid features undergoing myeloablative treatment analogous to AML or
- refractory anemia with excess of blasts (RAEB) or refractory anemia with excess of blasts in transformation (RAEB-t) with an IPSS score of >1.5 (appendix 10.8.) and
Key exclusion criteria (7 listed)
- Contraindication to myeloablative chemotherapy, intravenous lipids, or TPN
- Previous or concomitant chronic inflammatory bowel disease, unspecified colitis or pancreatitis
- Impaired hepatic or renal function as defined by:
- Other concurrent severe and/or uncontrolled medical condition
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 |
|---|---|---|
| omegavenTrial participants are prescribed TPN by the attending physician as soon as indicated, which will be administered via a central venous line over a time period of approximately 20 hours per day. The formulation given to all patients is Nutriflex lipid spezial®, an emulsion containing the full supply of carbohydrates, amino acids and lipids (SO:MCT = 1:1) with a total energy content of 2215 kcal in a 1875 ml volume, see Investigator's Brochure. In addition, they receive daily infusional Omegaven® 100 ml over 4 hours, which equal FO 10 g/d or omega-3 PUFA 3-6 g/d. | Dietary supplement | 1 |
Primary outcome
efficacy of an omega-3 PUFA containing lipid emulsion in reducing the incidence of °3-4 colitis (CTC AE v3.0)
Time frame: time to completion of cytotoxic chemotherapy
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 23 Jul 2015.
- Derived from this study: PubMed 23909727Bukki J, Stanga Z, Tellez FB, Duclos K, Kolev M, Krahenmann P, Pabst T, Iff S, Juni P. Omega-3 poly-unsaturated fatty acids for the prevention of severe neutropenic enterocolitis in patients with acute myeloid leukemia. Nutr Cancer. 2013;65(6):834-42. doi: 10.1080/01635581.2013.801998.
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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.
Johannes Bükki, MD principal investigator
Inselspital Berne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing omegaven in people with Colitis and Mucositis, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 7 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 23 Jul 2015. 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 Switzerland. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
efficacy of an omega-3 PUFA containing lipid emulsion in reducing the incidence of °3-4 colitis (CTC AE v3.0) (time frame: time to completion of cytotoxic chemotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00533078, which also lists 1 linked publication.
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 Jul 2015.