This study is a nonrandomized, single arm, open-label study stratified by iron-deficiency status.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
84
intravenous iron formulation
The Median Hb Change From Baseline to Week 12
The median Hb change from baseline to week 12 per patient in the three groups, Based on serum ferritin (sFr) and transferrin saturation(TSAT), patients were divided into the 3 groups: group I (absolute iron deficiency, n = 26) with sFr \< 30 ng/mL and TSAT \< 20%; group II (functional iron deficiency, n = 24) with sFr 30-800 ng/mL and TSAT \< 20%; and patients with TSAT ⩾ 20% were placed in group III as "others" (n = 34).
Time frame: up to 12 weeks
Percentage of Patients With Hb Increment of at Least 1.0 gm/dL.
Percentage of patients with Hb increment of at least 1.0 gm/dL during their participation (from baseline to week 12 per patient) in the three groups, Based on serum ferritin (sFr) and transferrin saturation(TSAT), patients were divided into the 3 groups: group I (absolute iron deficiency, n = 26) with sFr \< 30 ng/mL and TSAT \< 20%; group II (functional iron deficiency, n = 24) with sFr 30-800 ng/mL and TSAT \< 20%; and patients with TSAT ⩾ 20% were placed in group III as "others" (n = 34).
Time frame: up to 12 weeks
Percentage of Patients Achieving Correction of Anemia (Hb >11.0 gm/dL)
Percentage of patients achieving correction of anemia (Hb \>11.0 gm/dL) during their participation (from baseline to week 12 per patient) in the three groups. A total of 84 adult cancer patients on active chemotherapy with hemoglobin (Hb) level ⩽11.0 g/dL were recruited. Based on serum ferritin (sFr) and transferrin saturation(TSAT), patients were divided into 3 groups: group I (absolute iron deficiency, n = 26) with sFr \< 30 ng/mL and TSAT \< 20%; group II (functional iron deficiency, n = 24) with sFr 30-800 ng/mL and TSAT \< 20%; and patients with TSAT ⩾ 20% were placed in group III as "others" (n = 34).
Time frame: up to 12 weeks
Response Rate in Relation to Baseline Iron Deficiency Status
Response rate in relation to baseline iron deficiency status; Patients were considered responders if they showed a minimum of 1.0 gm/dL increment in Hb level during their participation (from baseline to week 12 per patient) Based on serum ferritin (sFr) and transferrin saturation(TSAT), patients were divided into 3 groups: group I (absolute iron deficiency, n = 26) with sFr \< 30 ng/mL and TSAT \< 20%; group II (functional iron deficiency, n = 24) with sFr 30-800 ng/mL and TSAT \< 20%; and patients with TSAT ⩾ 20% were placed in group III as "others" (n = 34).
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Time frame: up to 12 weeks
Percentage of Patients Who Will Require Blood Transfusion or ESA Treatment
Percentage of patients who received red blood cells (RBCs) transfusion or used erythropoietin during their participation (from baseline to week 12 per patient) among the 84 recruited adult cancer patients on active chemotherapy with hemoglobin (Hb) level ⩽11.0 g/dL
Time frame: up to 12 weeks