Neoplasms

All Conditions

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Nutritional and Metabolic Diseases

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Rare Diseases

Carcinoma

Anemia

Anemia, Iron-Deficiency

Iron Deficiencies

Nasopharyngeal Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Hematologic Diseases

Metabolic Diseases

Iron Metabolism Disorders

Anemia, Hypochromic

Nasopharyngeal Neoplasms

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Nasopharyngeal Diseases

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Micronutrients

All Drugs and Chemicals

Hematinics

Mineral

Iron

Iron isomaltoside 1000

Ferric Compounds

Trace Elements

Iron Supplement

Patients receive iron Isomaltide after anti-tumor therapy.

Patients receive polysaccharide iron complex after anti-tumor therapy.

Patients receive Iron isomaltoside after IC and CCRT

Iron Isomaltoside 1000

Patients receive Polysaccharide Iron Complex Pill after IC and CCRT

Polysaccharide Iron Complex Pill

All patients received intensity-modulated radiotherapy before enrolled.

Intensity-modulated radiotherapy

Qiu Yan Chen, Dr

Shan Shan Guo, Dr

Haiqiang Mai, MD,Ph.D

Qiuyan Chen, MD,Ph.D

Shanshan Guo, MD,Ph.D

Primary purpose： To evaluate the difference of hematopoietic response rate at 1 month after concurrent chemoradiotherapy between iron isomaltide and oral iron supplement for treating iron-deficiency anemia patients with locally advanced nasopharyngeal carcinoma.

Secondary purpose:

To evaluate the difference of hematopoietic response rate, tolerance, acute side effects, qualtiy of life at 2 months and 3 months after concurrent chemoradiotherapy between Iron Isomaltide and oral iron supplement for treating iron-deficiency anemia patients with locally advanced nasopharyngeal carcinoma.

Iron-deficiency anemia patients with locally advanced nasopharyngeal carcinoma will be enrolled and receive iron Isomaltide or oral iron supplement after randomised. The hematopoietic response rate, tolerance, acute side effects, qualtiy of life and long time survival would be evaluated.

Iron Isomaltide for Iron-deficiency Anemia Patients With Locally Advanced Nasopharyngeal Carcinoma

A Randomised Phase II Trial of Iron Isomaltide Versus Oral Iron Supplement for Radiotherapy or Chemotherapy Associated Iron-deficiency Anemia Patients With Locally Advanced Nasopharyngeal Carcinoma

Hematopoietic response rate at one month after IC+CCRT.

Hematopoietic response rate at two months after IC+CCRT.

Hematopoietic response rate at three months after IC+CCRT.

The acute side effects of iron isomaltide

The scores of each scale of quality of life questionaires for FACT-An

The difference of HGB after patients receiving iron supplements

Sun Yat-sen University

Professor

Iron isomaltoside intravenously as bolus or infusion

intravenously as bolus or infusion, 500 mg or 1000mg up to full replacement dose

iron isomaltoside 1000

oral, 200 mg per day (100 mg bid),12 weeks

iron sulphate

Lars Lykke Thomsen, MD

The purpose of this study is to compare the efficacy and safety of intravenous iron therapy with oral iron therapy in patients with cancer and chemotherapy induced anaemia.

A Study of Intravenous Iron Isomaltoside 1000 (Monofer®) as Mono Therapy (Without Erythropoiesis Stimulating Agents) in Comparison With Oral Iron Sulfate in Subjects With Non-myeloid Malignancies Associated With Chemotherapy Induced Anaemia (CIA)

A Phase III, Randomized, Open-label Study of Intravenous Iron Isomaltoside 1000 (Monofer®) as Mono Therapy (Without Erythropoiesis Stimulating Agents) in Comparison With Oral Iron Sulfate in Subjects With Non-myeloid Malignancies Associated With Chemotherapy Induced Anaemia (CIA)

Pharmacosmos A/S

The safety population included all subjects who were randomised and received at least one dose of iron isomaltoside 1000 or iron sulphate. The safety analyses was performed on the safety population.

Iron isomaltoside intravenously as bolus or infusion

iron isomaltoside 1000: intravenously as bolus or infusion, 500 mg or 1000mg up to full replacement dose

oral iron sulphate twice a day

iron sulphate: oral, 200 mg per day (100 mg bid),12 weeks

Iron Sulphate

Total

Age, Categorical

Sex: Female, Male

India

Germany

Denmark

Spain

Poland

Russian Federation

Sweden

United States

Region of Enrollment

Vice President Research & Development Department

The FAS population included all the subjects who were randomised into the study, received at least one dose of the study drug, and had at least one post-baseline Hb assessment. The subjects were considered as randomised, regardless of which treatment they actually received.

Change in Hb Concentration

Change in Hemoglobin From Baseline to Week 24

Overall Study

Digestive System Diseases

Esophageal Neoplasms

Adenocarcinoma

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Esophageal Diseases

Esophageal Cancer

Stomach Cancer

Standard Care as determined by the clinical team

Intravenous Iron Isomaltoside 1000 (Monofer®)will be administered in line with the summary of product characteristics.

Barrie D Keeler, FRCS

Austin G Acheson, MD FRCS

40 eligible patients with confirmed esophageal or gastric adenocarcinoma and anemia will be randomized to a control or intervention group for management of this anemia. The control group treatment will consist of standard treatments as governed by the clinical team (eg oral iron, blood transfusions) whilst the intervention group will be treated with intravenous iron III isomaltoside (Monofer ®).

It is hypothesized that intravenous iron supplementation is more efficacious than standard therapies.

Anemia is a common problem to affect patients diagnosed with esophageal or gastric cancer. This anemia is thought to be secondary to blood loss from the tumor, poor oral intake resulting from symptoms of the tumor, and impaired iron absorption secondary to neoplasia induced inflammatory processes.

Patients undergoing palliative chemotherapy for esophageal or gastric adenocarcinoma are thus prone to development or exacerbation of anemia during their chemotherapy, as this tumor is remains in situ.

Anemia results in symptoms such as shortness of breath, fatigue, lethargy and chest pain, which can all affect quality of life. Oral iron and blood transfusions are the current mainstay of treatment for the condition, yet both have their disadvantages. Oral iron is often poorly tolerated due to side effects including constipation, diarrhea, abdominal pain and nausea. Blood transfusions can also be administered but expose the patient to other risks including infection and transfusion associated reactions. In order to overcome these issues, intravenous iron preparations have been developed and have improved in safety.

This is a single-center, randomized, open label, clinical trial, which looks to investigate the efficacy of intravenous iron is in the treatment of anemia in patients with a diagnosis of esophageal or gastric adenocarcinoma.

Patients will be randomized to receive intravenous iron III isomaltoside (treatment group) or standard therapies decided by the clinical team (control). The outcomes reviewed will include the amount and frequency of blood transfusions received, changes in patient blood profiles and most importantly, patient quality of life scores. Patients will be followed from the start of their chemotherapy until the beginning of the third cycle.

The primary hypothesis to be tested is that intravenous iron will increase quality of life by reducing the symptoms of anemia. We also hypothesize that there will be a decrease in blood transfusion rate in this group and improved changes in hemoglobin and hematinics.

This is designed as a pilot study to determine the feasibility of a larger trial. Randomization will be performed using random allocation of opaque envelopes. All data will be confidentially recorded, as will drug reactions and side effects.

Iron Replacement in Oesophagogastric Neoplasia

An Pilot Study to Assess the Efficacy of Intravenous Iron Isomaltoside 1000 (Monofer®) in the Management of Anaemia Associated With the Palliative Management of Oesophagogastric Adenocarcinoma

This will govern the magnitude of treatment effect, and hence aid design of a larger study.

To compare quality of life scores as determined by the EQ-5D and FACT-An questionnaires between treatment groups

To investigate if the number of units transfused per participant, the number of participants whom received a blood transfusion and the total number of units of blood transfused differs between the two study arms. This period monitored will begin at enrolment into the study, and cease at the start of the third cycle of chemotherapy

To evaluate if hematinic markers (ferritin, iron, transferrin, transferrin) differ between treatment arms.

Nottingham University Hospitals NHS Trust

Heart and Blood Diseases

Heart Failure

Observation of real-life treatment with iron isomaltoside 1000 / Iron Derisomaltose 1000

Real-CHOICE - designed as a prospective, longitudinal, observational, non-interventional study - will investigate the attitude of patients and physicians towards IV (intravenous) iron therapy in general and IIM (iron isomaltoside 1000) treatment particularly before and after IIM treatment in iron deficient patients with or without anemia in the real-world clinical setting after commercial availability of this product in Switzerland.

Real Life Study on Iron Isomaltoside 1000 in the Treatment of ID in CKD, Heart Failure, ObGyn, IBD, Cancer and Elective Surgery (Real-CHOICE).

Iron Isomaltoside 1000 in Patients With Iron Deficiency or Iron Deficiency Anemia: a Multicentric, Prospective, Longitudinal, Observational Study in Switzerland.

Rate of patients with stability or positive change in attitude.

Questionnaire comprises the following questions:

1. I am hesitant to be treated with IV iron.
2. I would consider IV iron treatment due to the physician ́s choice.
3. I would consider IV iron treatment due to its safety compared to other iron treatment options.
4. I would consider IV iron treatment due to its efficacy compared to other iron treatment options.

Iron deficiency anemia (IDA): Hb (Hemoglobin) increase ≥ 1 g/dL.

Iron deficiency without anemia (IDNA): Maintenance of baseline Hb-level and/or Hb above lower limit of normal (LLN).

Taking into account baseline (BL) and follow-up (FU) answers.

Questionnaire comprises the following questions:

1. I am hesitant to be treated with IIM.
2. I would consider IIM treatment due to the physician ́s choice.
3. I would consider IIM treatment due to its safety compared to other iron treatment options.
4. I would consider IIM treatment due to its efficacy compared to other iron treatment options.
5. I would consider IIM treatment due to its specific dosing and administration schedule.

Questionnaire comprises the following questions:

1. I am hesitant to treat with IV iron.
2. I would consider IV iron treatment due to the patient ́s desire.
3. I would consider IV iron treatment due to its safety compared to other iron treatment options.
4. I would consider IV iron treatment due to its efficacy compared to other iron treatment options.

And:

1. I am hesitant to treat with IIM.
2. I would consider IIM treatment due to the patient ́s desire.
3. I would consider IIM treatment due to its safety compared to other iron treatment options.
4. I would consider IIM treatment due to its efficacy compared to other iron treatment options.
5. I would consider IIM treatment due to its specific dosing and administration schedule.

Difference between administered IIM dose and calculated iron need.

Reasons for treatment choice of IIM in current patient populations. Reasons could be: efficacy, safety profile, quality of life, patient's preference, physician's preference, comorbidities, convenient dosing, other.

Rate of physicians and patients with stability or positive change in satisfaction upon IIM treatment.

Number of patients with:

* Treatment-emergent adverse events (maximum grade per patient),
* Grade 3/4 treatment-emergent adverse drug reactions,
* Grade 3/4 treatment-emergent serious adverse events,
* Treatment-emergent serious adverse drug reactions,
* Pre-treatment adverse events,
* Pre-treatment serious adverse events,
* Follow-up adverse events,
* Follow-up serious adverse events.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Iron Isomaltide for Iron-deficiency Anemia Patients With Locally Advanced Nasopharyngeal Carcinoma	NCT05913414	Nasopharyngeal ... Iron-deficiency Anemia	Iron Isomaltosi... Polysaccharide ... Intensity-modul...	18 Years - 65 Years	Sun Yat-sen University
A Study of Intravenous Iron Isomaltoside 1000 (Monofer®) as Mono Therapy (Without Erythropoiesis Stimulating Agents) in Comparison With Oral Iron Sulfate in Subjects With Non-myeloid Malignancies Associated With Chemotherapy Induced Anaemia (CIA)	NCT01145638	Non-myeloid Mal... Chemotherapy In...	iron isomaltosi... iron sulphate	18 Years -	Pharmacosmos A/S
Iron Replacement in Oesophagogastric Neoplasia	NCT01927328	Anemia Esophageal Canc... Gastric Cancer	Iron isomaltosi...	18 Years -	Nottingham University Hospitals NHS Trust
Iron Replacement in Oesophagogastric Neoplasia	NCT01927328	Anemia Esophageal Canc... Gastric Cancer	Iron isomaltosi...	18 Years -	Nottingham University Hospitals NHS Trust
Real Life Study on Iron Isomaltoside 1000 in the Treatment of ID in CKD, Heart Failure, ObGyn, IBD, Cancer and Elective Surgery (Real-CHOICE).	NCT04318405	Iron-Deficiency... Iron-Deficiency	Iron isomaltosi...	18 Years -	Pierre Fabre Pharma AG
Iron Isomaltide for Iron-deficiency Anemia Patients With Locally Advanced Nasopharyngeal Carcinoma	NCT05913414	Nasopharyngeal ... Iron-deficiency Anemia	Iron Isomaltosi... Polysaccharide ... Intensity-modul...	18 Years - 65 Years	Sun Yat-sen University
A Study of Intravenous Iron Isomaltoside 1000 (Monofer®) as Mono Therapy (Without Erythropoiesis Stimulating Agents) in Comparison With Oral Iron Sulfate in Subjects With Non-myeloid Malignancies Associated With Chemotherapy Induced Anaemia (CIA)	NCT01145638	Non-myeloid Mal... Chemotherapy In...	iron isomaltosi... iron sulphate	18 Years -	Pharmacosmos A/S

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