Infections

All Conditions

Symptoms and General Pathology

Digestive System Diseases

Neoplasms

Blood and Lymph Conditions

Mouth and Tooth Diseases

Rare Diseases

Communicable Diseases

Colitis

Hematologic Neoplasms

Neutropenia

Mucositis

Gastroenteritis

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Mouth Diseases

Stomatognathic Diseases

Hematologic Diseases

Granulocytopenia

Other Dietary Supplements

All Drugs and Chemicals

Omega 3 Fatty Acid

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.

omegaven

Johannes Bükki, MD

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.

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.

Lipid Use, Nutrition, and Colitis in Patients With Hematological Malignancies

Lipid Use, Nutrition, and Colitis in Patients With Hematological Malignancies (LUNCH1)

Insel Gruppe AG, University Hospital Bern

Johannes Buekki, MD

Colonic Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Micronutrients

Vitamins

Herbal and Botanical

Tocopherols

Vitamin E

Tocotrienols

alpha-Tocopherol

Antioxidants

Protective Agents

Trace Elements

Tocopherol

Tocotrienol

Cola

2 infusions of NaCl, 2 ml/kg, one the night before operation and one the day after operation.

2 infusions of 2ml/kg, one the night before surgery and one the day after surgery

2 infusions, 2 ml/kg, one the night before operation and one the day after operation

Omegaven

Placebo

A.P.J. Houdijk, Dr.

Ideally, the postoperative inflammatory response is part of a well-orchestrated mechanism that contributes to tissue healing and rapid recovery. An exaggerated uncontrolled inflammatory response, however may lead to catabolism, tissue damage and organ failure. Omega-3 fatty acids may provide a means to alter cellular immune responses to the benefit of the patient. When omega-3 fatty acids are incorporated into membranes of inflammatory cells, they trigger intracellular signalling pathways that result in a less pro-inflammatory response. They modify gene and protein expression, modulate membrane protein activity and act as a reservoir for bioactive molecules. They also have a strong anti-inflammatory effect by mediating resolution of the inflammation. Furthermore, omega-3 fatty acids improve erythrocyte function, which is vital for an adequate microcirculation, tissue oxygenation and wound healing.

The investigators hypothesize that the perioperative administration of intravenous omega-3 fatty acids results in a rapid incorporation in immune cells and erythrocytes, thereby reducing the postoperative inflammatory response and improving erythrocyte function in patients undergoing colorectal surgery.

Effect of Omega-3 Fatty Acids on the Perioperative Immune Response and Erythrocyte Function

Effect of Intravenous Omega-3 Fatty Acids on the Perioperative Immune Response and Erythrocyte Function in Patients With Colon Cancer

Length of hospital stay and occurence of surgical site infection, abscess, urinary tract infection, pneumonia, anastomotic leakage, need for Intensive Care Unit admission, Systemic Inflammatory Response Syndrome, Multi Organ Failure, any adverse events.

Neuropsychological examination using a reading test, an auditory verbal learning test, WAIS III figure series and trail making tests.

Ex vivo stimulation of whole blood with LPS (lipopolysaccharide, component of gram negative bacteria) resulting in the production of the pro-inflammatory cytokine IL-6, measured in ng/ml.

Ex vivo stimulation of whole blood with LPS (lipopolysaccharide, component of gram negative bacteria) resulting in the production of the pro-inflammatory cytokine TNF-α (tumor necrosis factor-α), and the anti-inflammatory cytokine IL-10 (interleukine-10), both measured in ng/ml.

Erythrocyte deformability and aggregation measured by LORRCA (laser assisted optical rotational red cell analyzer)

White blood cell count, C-reactive protein and cytokine levels (Interleukine-6, Tumor Necrosis Factor-α and Interleukine-10) in serum.

Medical Center Alkmaar

Wounds and Injuries

This is a compassionate use study. All participants will receive intravenous Omegaven (10% fish oil emulsion) with parenteral nutrition for 4 weeks.

initial dose of 0.1 g/kg body weight (1ml/kg) and increased to 0.2 g/kg body weight (2ml/kg) on day 2 or 3 of treatment. The infusion rate will not exceed 0.5mL Omegaven/kg body weight/hr (corresponding to 0.05g fish oil/kg/hr). Patients will receive the initial infusion of PN containing Omegaven at Midwestern Regional Medical Center (MRMC) in the infusion center to observe for adverse reactions. Patients will continue to receive infusions at MRMC for the first 2 to 3 days of dosing. After tolerance is established, patients will receive treatment at home. All study patients will have a Screening Visit; Day 1, Day 2 and Day 3 visits; and weekly visits for one month.

Pankaj Vashi, MD

The purposes of this study are to make Omegaven® available to cancer patients with liver disease and to determine if Omegaven® can improve or prevent further liver disease. The study will also look at the effects Omegaven® has on immune function.

This compassionate use study will include patients with advanced cancer requiring PN for long-term nutrition support who have developed PN-induced hepatic injury or who have existing hepatic dysfunction. Therapy with Omegaven will be provided at an initial dose of 0.1 g/kg body weight (1ml/kg) and increased to 0.2 g/kg body weight (2ml/kg) on day 2 or 3 of treatment. For patients \> 120% ideal body weight, adjusted body weight will be used. The infusion rate will not exceed 0.5mL Omegaven/kg body weight/hr (corresponding to 0.05g fish oil/kg/hr). Omegaven will be co-administered via a y-site infusion, with containers being changed every 12 hours. The patient may receive other lipids to meet Essential Fatty Acid (EFA) and/or additional calorie needs. Patients will receive the initial infusion of PN containing Omegaven at Midwestern Regional Medical Center (MRMC) in the infusion center to observe for adverse reactions. If an adverse reaction is observed, IV steroids \& benadryl will be administered \& Omegaven will be discontinued. Patients will continue to receive infusions at CTCA for the first 2 to 3 days of dosing. After tolerance is established, patients will receive treatment at home with Coram. All study patients will have a Screening Visit; Day 1, Day 2 and Day 3 visits; and weekly visits for one month (see Table 2).

Compassionate Use of Omegaven® in the Treatment of Parenteral Nutrition Induced Hepatic Injury

At present, no plan to share individual participant data.

Highest detected lab values will be summarized between baseline and end of study participation.

lab values will be summarized at baseline and as change from baseline to worst follow-up value.

The number of patients reporting or experiencing adverse effects will be reported.

Lab values will be summarized at b aselin4e and as change from baseline to worst follow-up value.

Laboratory values will be summarized at baseline and as change from baseline to worst follow-up value

Midwestern Regional Medical Center

Lead National Medical Director, National Director Gastroenterology, Nutrition & Metabolic Support

This is a compassionate use study. All participants will receive intravenous Omegaven (10% fish oil emulsion) with parenteral nutrition for 4 weeks.

Omegaven: initial dose of 0.1 g/kg body weight (1ml/kg) and increased to 0.2 g/kg body weight (2ml/kg) on day 2 or 3 of treatment. The infusion rate will not exceed 0.5mL Omegaven/kg body weight/hr (corresponding to 0.05g fish oil/kg/hr). Patients will receive the initial infusion of PN containing Omegaven at Midwestern Regional Medical Center (MRMC) in the infusion center to observe for adverse reactions. Patients will continue to receive infusions at MRMC for the first 2 to 3 days of dosing. After tolerance is established, patients will receive treatment at home. All study patients will have a Screening Visit; Day 1, Day 2 and Day 3 visits; and weekly visits for one month.

Omegaven (Compassionate Use)

Age, Categorical

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

United States

Region of Enrollment

Director of Clinical Trials

Maximum Conjugated Bilirubin

Baseline

4 Week Nadir

Average Improvement in Alkaline Phosphatase

Average Change in Alkaline Phosphatase

Number of Patients Experiencing Adverse Events

4 Weeks Nadir

Average Improvement in AST

Average Improvement in ALT

Overall Study

Carcinoma

Adenocarcinoma

Stomach Neoplasms

Esophageal Neoplasms

Head and Neck Neoplasms

Esophageal Diseases

Stomach Diseases

Stomach Cancer

Esophageal Cancer

Antineoplastic Agents

Capecitabine

Epirubicin

Oxaliplatin

Omegaven in combination with EOX chemotherapy

Weekly omegaven infusion in combination with EOX chemotherapy

David J Bowrey, MD

The prognosis for patients with advanced oesophago-gastric cancer is poor. Approximately 16,000 patients in the United Kingdom die from the disease. In spite of new chemotherapy regimens, the average survival for these patients is around 9 months from diagnosis.

Omegaven is an infusion comprising omega-3 fish oils. There is evidence that omega-3 fish oil supplementation can improve general well-being and quality of life in patients receiving palliative chemotherapy for a number of different cancer types. It has also been suggested that omega-3 fish oil supplementation may reduce the toxicity of chemotherapy.

This clinical trial aims to see whether the addition of Omegaven to EOX chemotherapy, the most widely used regimen for patients with advanced oesophago-gastric cancer, will make this drug regimen more effective at killing oesophago-gastric cancer cells, such that disease progression is delayed. Forty-five patients who have been diagnosed with advanced oesophago-gastric cancer will be recruited over a two year period to receive standard chemotherapy and omega-3 fish oil supplementation. The results in these 45 patients will be compared to a matched historical control group of patients who have received identical chemotherapy. If results suggest that the combination of EOX and Omegaven is sufficiently effective, tolerable and feasible then it will be the intention of the trial team to take the combination forward to treat patients with advanced oesophago-gastric cancer in a randomised study.

Study of Additive Omega-3 Fish Oil to Palliative Chemotherapy to Treat Oesophagogastric Cancer

Phase II Trial of Palliative Epirubicin, Oxaliplatin & Capecitabine (EOX) Chemotherapy Combined With Omega-3 Fish Oil Infusion (Omegaven) in Patients With Oesophagogastric Carcinoma

Progression free survival from enrolment to disease progression

The number of participants requiring dose delays

Objective response rate as assessed by RECIST v1.1

The number of participants experiencing adverse effects

The number of participants requiring dose modifications

The number of participants requiring treatment withdrawal due to adverse effects

University Hospitals, Leicester

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Neoplasms by Histologic Type

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Anti-Infective Agents

Cytarabine

Daunorubicin

Antimetabolites

Antiviral Agents

Immunosuppressive Agents

Immunologic Factors

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

If WBC ≥ 30 G/L, chemotherapy the induction cycle :

* Daunorubicin 60 mg/m²/day IV on D1, D2, and D3
* Cytarabine 200 mg/m²/day D1 to D7
* OMEGAVEN® 2 ml/kg D1 to D9,

If WBC ≤ 30 G/L, OMEGAVEN during 48 hours

Induction cycle :

OMEGAVEN® 2 ml/kg D-2 to D7 Daunorubicin 60 mg/m²/day IV on D1, D2, and D3

- Cytarabine 200 mg/m²/day IV D1 to D7

bone marrow aspirate at D15: If BM blasts are \> 5% or if second induction course :

* Daunorubicin 35 mg/m²/day IV D17 and D18
* OMEGAVEN® 2 ml/kg
* Cytarabine 1000 mg/m²/12h IV on D17, D18, and D19

For all patients: G-CSF 5 µg/kg/day subcutaneously from D21 to hematopoietic recovery (PMN \> 1 G/L or \> 0.5 G/L during 3 days).

Consolidation will be administered at investigator's discretion

OMEGAVEN

Emmanuel GYAN, MD

Pilot study of the efficacy and tolerance of the adjunction of a Fish oil emulsion to daunorubicin and cytarabine chemotherapy for the treatment of Acute MYeloblastic Leukemia of Younger patients (under 61 years) with high-risk cytogenetics.

Adjunction of a Fish oil emulsion OMEGAVEN to daunorubicin and cytarabine chemotherapy for the treatment of Acute MYeloblastic Leukemia of Younger patients.

Pilot Study Efficacy and Tolerance Fish Oil Emulsion Daunorubicin and Cytarabine Treatment of AML Younger Patients

Pilot Study of the Efficacy and Tolerance of the Adjunction of a Fish Oil Emulsion to Daunorubicin and Cytarabine Chemotherapy for the Treatment of Acute MYeloblastic Leukemia of Younger Patients With High-risk Cytogenetics

Number of patients incomplete response rate after the adjunction of a Fish oil emulsion to daunorubicin and cytarabine chemotherapy for the induction of untreated AML

Number of patients with side effects during and after the admistration of a Fish oil emulsion with daunorubicin and cytarabine chemotherapy for the induction of untreated AML

Daily quantification of peripheral blasts by flow cytometry during the adjunction of a Fish oil emulsion to daunorubicin and cytarabine chemotherapy

Measure of plasma concentration of daunorubicin and cytarabine administered together with a fish oil emulsion

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Lipid Use, Nutrition, and Colitis in Patients With Hematological Malignancies	NCT00533078	Colitis Mucositis AML	omegaven	18 Years -	Insel Gruppe AG, University Hospital Bern
Effect of Omega-3 Fatty Acids on the Perioperative Immune Response and Erythrocyte Function	NCT02231203	Colon Cancer	Omegaven Placebo	60 Years - 80 Years	Medical Center Alkmaar
Compassionate Use of Omegaven® in the Treatment of Parenteral Nutrition Induced Hepatic Injury	NCT01325584	Cancer Hepatic Injury	Omegaven	18 Years - 80 Years	Midwestern Regional Medical Center
Study of Additive Omega-3 Fish Oil to Palliative Chemotherapy to Treat Oesophagogastric Cancer	NCT01870791	Esophageal Neop... Gastric Neoplas...	Omegaven	18 Years -	University Hospitals, Leicester
Pilot Study Efficacy and Tolerance Fish Oil Emulsion Daunorubicin and Cytarabine Treatment of AML Younger Patients	NCT01999413	Acute Myeloid L...	OMEGAVEN Daunorubicin Cytarabine	18 Years - 61 Years	French Innovative Leukemia Organisation
Pilot Study Efficacy and Tolerance Fish Oil Emulsion Daunorubicin and Cytarabine Treatment of AML Younger Patients	NCT01999413	Acute Myeloid L...	OMEGAVEN Daunorubicin Cytarabine	18 Years - 61 Years	French Innovative Leukemia Organisation
Effect of Omega-3 Fatty Acids on the Perioperative Immune Response and Erythrocyte Function	NCT02231203	Colon Cancer	Omegaven Placebo	60 Years - 80 Years	Medical Center Alkmaar

Spots Global Cancer Trial Database for omegaven

Every month we try and update this database with for omegaven cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for omegaven

Every month we try and update this database with for omegaven cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for omegaven cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.