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For patients undergoing chemotherapy, ferinject 1000mg will be injected within 24 hours or 24 hours after day 1 of the next chemotherapy cycle.

Patients using targeted therapies can be dosed at any time after recognizing Hb 8.0-10.5g / dL and injecting 1000 mg of ferinject.

Treatment for anemia will include remedies such as iron (oral or intravenous), hematopoietic accelerators, and blood transfusions, and will be determined by researchers at each institution to provide optimal treatment for patients.

Ferinject

JunHO Jang, ph.D

JunHo Jang, ph.D

* Multifactorial pathogenesis is involved in anemia of cancer patients and defining the causes of anemia is not always simple.
* Currently, treatment options available for anemia in cancer patients include red blood cell (RBC) transfusion, erythropoietin stimulating agent (ESA), and iron supplementation, accompanying considerable pros and cons for each treatment.
* Previous studies have demonstrated benefit when treating with IV iron in combination with ESA and, more recently, evidence is emerging to suggest a role for IV iron alone.
* In this study, investigator will assess the efficacy of intravenous iron for the treatment of anemia in cancer patients.
* Improvement of anemia and the improvement of quality of life compared to conservative treatment of intravenous iron

This study is a comparative clinical trial of prospective, multicenter, randomized trials to evaluate the efficacy of intravenous iron (Ferinject®) in cancer patients with anemia.

Changes in hemoglobin in the treated and conservative treatment groups with a single intravenous Ferrinject® in patients with anemia by chemotherapy are identified.

1. Clinical Drug Ferinject Injection For patients undergoing chemotherapy, ferinject 1000mg will be injected within 24 hours or 24 hours after day 1 of the next chemotherapy cycle.

   Patients using targeted therapies can be dosed at any time after recognizing Hb 8.0-10.5g / dL and injecting 1000 mg of ferinject.
   * The administration of ferinject is a single dose, no re-administration. If chemotherapy is not performed, it can be administered at any time if the selection and exclusion criteria are met.
   * The administration period for ferinject should be administered within 24 hours or 24 hours after the day 1 of the chemotherapy cycle based on the results of phase 2 studies
2. remedies Within the period of sample collection of visits 2 to 4 after study enrollment, if the physician determines that treatment for clinically meaningful anemia is necessary, treatment for anemia other than ferinjects will be followed. Treatment for anemia will include remedies such as iron (oral or intravenous), hematopoietic accelerators, and blood transfusions, and will be determined by researchers at each institution to provide optimal treatment for patients. At the time this treatment is administered, the subject will be dropped from the clinical trial.

Intravenous Iron Injection in Cancer Patients With Anemia

Multicenter Randomized Study on the Efficacy of Intravenous Iron Injection in Cancer Patients With Anemia

Samsung Medical Center

Professor

Nutritional and Metabolic Diseases

Anemia, Iron-Deficiency

Iron Deficiencies

Metabolic Diseases

Iron Metabolism Disorders

Anemia, Hypochromic

Ferinject will be administered once at inclusion

DELPHINE CORNUAULT-FOUBERT, MD

In oncology, anemia is a frequent symptom, leading to complication of patient management for, more or less, a long term but often poorly evaluated by medical teams.

In oncology, anemia is induced by multiple causes. Iron deficiency appears to be a leading cause of anemia, especially in people with solid cancer. Iron deficiency is characterized by a low level of iron . Iron is a trace element required for life. It is a major component of hemoglobin allowing the transport of oxygen in red blood cells. There are in fact 2 types of iron deficiency: an absolute iron deficiency with a deficiency of true iron and a functional iron deficiency. Since end of January 2014, intravenous iron-based injections have been reclassified for cancer patients at ICO Paul Papin. The monitoring of iron deficiency with or without anemia is currently done in our institute, the ICO-Paul Papin. There is a procedure for the management of anemia with or without iron deficiency but there is still no traceability of treatments performed, their compliance or even their impact on the rate hemoglobin and the quality of life of patients during their treatment. This observatory also makes it possible to evaluate the impact of this treatment on the quality of life of the patients and thus allows them a personalized care of the tiredness during their treatment

The study is for patients with iron deficiency and / or anemia during treatment for cancer These patients will receive ferinject. Patients will perform functional assessments and complete quality of life questionnaires, when the ferinject will be injected, then at 1 month and 6 months.

Patients will be followed for 6 months in the study

Impact and Evaluation of the Management of Iron Deficiency With or Without Anemia in Patients With Cancer

Obtained with the quality of life with the FACT-An questionnaire.

Absolute iron deficiency is defined by a ferritin level \<300 μg / L and a transferrin saturation coefficient \<20%.

Functional iron deficiency is defined by a ferritin level \<800 μg / L and a Transferrin Saturation Coefficient \<20%.

Addition of proportion of iron deficiency

Symptomatic anemia is defined as hemoglobin \<12 g / dL associated with pallor and anoxic functional symptoms

Asymptomatic anemia is defined as hemoglobin \<12 g / dL without clinical signs.

Addition of proportion of asymptomatic anemia and symptomatic anemia

The diagnosis of malnutrition will be done by calculating BMI (\<18.5 si - 70 years old and \<21 from 70 years old)

Estimated by functional questionnaire (Berg Balanced Scale test)

Estimated by functional questionnaire (the Tinetti test)

Estimated by functional questionnaire (the Timed Up and Go test)

Estimated by functional questionnaire (the 6-minute walk test)

Estimated by functional questionnaire (the 1-minute sit-stand test)

Estimated by functional questionnaire (the climb and descent test of a staircase for 1 minute)

Institut Cancerologie de l'Ouest

Neoplasms

Digestive System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

max. 2.000 mg of ferric carboxymaltose over max. 2 weeks (max. 1.000 mg per week).

FerInject: max. 2.000 mg of ferric carboxymaltose over max. 2 weeks (max. 1.000 mg per week).

FerInject

Ferro sanol

Iron deficiency has a high prevalence in colorectal cancer patients ranging at ca. 60%. About 70% of these patients suffer from iron deficiency anemia (IDA) which adds both physical and cognitive impediments to an already straining chemotherapy. Moreover, a chronic disease like cancer often results in a reduced availability of iron for the body. In clinical practice iron substitution is usually administered orally. Due to low resorption rates, frequent gastric side effects and thus poor patient compliance a parenteral substitution seems to be a better option in terms of efficacy. In the framework of a randomized multicenter clinical trial ('FerInject') a comparison of efficacy parameters of parenteral vs. oral iron substitution will now be conducted in order to identify the best treatment form for clinical practice in oncology. Furthermore detailed quality of life-data (QoL) will be collected in both treatment arms for effect comparison.

Intravenous Ferric Carboxymaltose vs. Oral Iron Substitution in Patients With Metastatic Colorectal Cancer (CRC) and Iron Deficiency Anemia: a Randomized Multicenter Treatment Optimization Study.

incidence and severity of adverse events according to CTCAE (Common Terminology Criteria for Adverse Events) Version 4 criteria as assessed at day 1, 8, 15, 36, 50 and 64 and at end of treatment.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Intravenous Iron Injection in Cancer Patients With Anemia	NCT04187716	Cancer Anaemia	Ferinject	19 Years -	Samsung Medical Center
Impact and Evaluation of the Management of Iron Deficiency With or Without Anemia in Patients With Cancer	NCT03625661	Iron Deficiency...	Ferinject	18 Years -	Institut Cancerologie de l'Ouest
Intravenous Ferric Carboxymaltose vs. Oral Iron Substitution in Patients With Metastatic Colorectal Cancer (CRC) and Iron Deficiency Anemia: a Randomized Multicenter Treatment Optimization Study.	NCT02469480	Metastatic Colo...	FerInject Ferro sanol	18 Years -	Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Intravenous Iron Injection in Cancer Patients With Anemia	NCT04187716	Cancer Anaemia	Ferinject	19 Years -	Samsung Medical Center
Impact and Evaluation of the Management of Iron Deficiency With or Without Anemia in Patients With Cancer	NCT03625661	Iron Deficiency...	Ferinject	18 Years -	Institut Cancerologie de l'Ouest
Intravenous Ferric Carboxymaltose vs. Oral Iron Substitution in Patients With Metastatic Colorectal Cancer (CRC) and Iron Deficiency Anemia: a Randomized Multicenter Treatment Optimization Study.	NCT02469480	Metastatic Colo...	FerInject Ferro sanol	18 Years -	Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Intravenous Ferric Carboxymaltose vs. Oral Iron Substitution in Patients With Metastatic Colorectal Cancer (CRC) and Iron Deficiency Anemia: a Randomized Multicenter Treatment Optimization Study.	NCT02469480	Metastatic Colo...	FerInject Ferro sanol	18 Years -	Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Spots Global Cancer Trial Database for ferinject

Every month we try and update this database with for ferinject 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 ferinject

Every month we try and update this database with for ferinject 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 ferinject 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.