Health Condition 1: C00-D49- Neoplasms
Conditions
Interventions
None listed
Sponsors
Dr Malini Mohan
Eligibility
Inclusion criteria
Inclusion criteria: - Hemoglobin level less than or equal to 10 g/dL - Transferrin saturation - Any stage solid malignancies
Exclusion criteria
Exclusion criteria: - Age less than 18yrs - Pregnant women - any evidence of hemolysis - Active gastrointestinal bleeding (stool occult blood positive) - active infection requiring systemic antibiotics - HIV infection - active Tuberculosis infection - liver/ renal dysfunction - Grade 2 or higher based on National Cancer Institute Common Toxicity Criteria: Bilirubin >1.5 times normal, Transaminases >2.5 times normal), renal dysfunction (serum creatinine levels > or equal to 2.0 mg/dL) - Malignant Bone marrow infiltration -Received iron supplementation / blood transfusion in the preceding 4 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Prevalence of patients with absolute and functional iron deficiency anemia Timepoint: 2 years | — |
Secondary
| Measure | Time frame |
|---|---|
| a)Best response to treatment - Response will be defined as proportion of patients achieving an increase in hemoglobin at any time from baseline to end of 12 weeks. Response criteria is defined as follows: - Complete response : increase in Hemoglobin level 2.0 g/dL above baseline, and/ or transfusion free. Partial response : increase in Hemoglobin level (1g/dL-2g/dL) above baseline Minor response : increase in Hemoglobin level ( 0.5 g/dL-1g/dL) above baseline b)Efficacy assessment with quality of life questionnaire (Functional assessment of cancer therapy- Anemia ( FACT An )) Timepoint: 2 years | — |
Countries
India
Contacts
Public ContactDr Karthik Udupa
Kasturba Medical College Manipal
Outcome results
None listed