Cancer-related anemia
Conditions
Interventions
Observation group:Iron carboxymaltose therapy
Control group:Oral iron therapy
Sponsors
Chongqing Jiangjin Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged between 18 and 80 years; 2. Patients diagnosed with tumor-associated anemia with iron deficiency: Hb <110 g/L (females) or <120 g/L (males) at the screening visit, and SF <30ug/L and TSAT <20%;OR SF 30-500ug/L with TSAT <50%; or SF 500-800ug/L with TSAT <50%. 3. When rapid iron supplementation is clinically indicated; 4. Subjects who are able to understand the study requirements and comply with the study limitations, as well as those who agree to return for the required evaluations; 5. Appropriate written informed consent must be obtained prior to performing any study-specific procedures. (Remarks: serum ferritin: SF, transferrin saturation: TSAT)
Exclusion criteria
Exclusion criteria: 1. Hypersensitivity to the product, its active ingredients and any excipients; 2. Severe hepatic and renal dysfunction; 3. Known severe hypersensitivity reactions to other parenteral iron agents; 4. Anemia not due to iron deficiency, such as other types of microcytic anemia; 5. The presence of iron overload or impaired iron utilization; 6. The current use of other drugs that affect iron metabolism; 7. Known hemoglobin-like disorders (e.g., thalassemia) 8. Any history or clinical manifestation of anemia associated with the following conditions: Hematuria Vitamin B12 or folate deficiency requiring treatment (subjects may be enrolled after correction of deficiency); 9. planned surgery with anticipated blood loss (defined as a decrease in Hb > 2 g/dl) within 3 months of randomization; or Hemodialysis (current or planned within the next 3 months). 10. Subjects participating in more than one clinical trial at the same time.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemoglobin;Serum ferritin;Transferrin saturation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Security; | — |
Countries
China
Contacts
Public ContactChunrong Wu, Pengchun Fang
Chongqing Jiangjin Central Hospital
Outcome results
None listed