NCT04246021

Use of Intravenous Ferric Carboxymaltose in Treatment of Anemia in Cancer Patients Undergoing Chemotherapy

The Use of Intravenous Ferric Carboxymaltose (FCM) Without Erythropoiesis-stimulating Agents (ESA) in the Treatment of Anemia in Cancer Patients Undergoing Chemotherapy With or Without Radiotherapy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: King Hussein Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a nonrandomized, single arm, open-label study stratified by iron-deficiency status.

Detailed description

The study aims to investigate the effect of FCM (without ESAs) on anemic cancer patients undergoing chemotherapy (with or without radiotherapy); stratified by status of iron deficiency (i.e. non-iron deficient vs. iron deficient patients ). The study will also try to find out whether serum level of Hepcidin and C reactive protein can correlate with response Patients will receive one or two doses of FCM, based on the body weight and Hb level. Patients will be followed-up for a total of twelve weeks. The study is divided into a screening, treatment and follow-up phases and is expected to be completed in 12 months.

Conditions

• Anemia
• Cancer

Interventions

Type	Name	Description
DRUG	Ferric carboxymaltose (FCM)	intravenous iron formulation

Timeline

• Start date: 2016-06-15
• Primary completion: 2017-12-31
• Completion: 2017-12-31
• First posted: 2020-01-29
• Last updated: 2022-01-04
• Results posted: 2021-12-08