To find the number of cancer patients having lower than normal healthy red blood cell due to low iron in body, and how this affects their treatment
- Conditions
- Health Condition 1: C00-D49- Neoplasms
- Registration Number
- CTRI/2022/06/043104
- Lead Sponsor
- Dr Malini Mohan
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Hemoglobin level less than or equal to 10 g/dL
- Transferrin saturation < 20 %
- Any stage solid malignancies
- 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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Prevalence of patients with absolute and functional iron deficiency anemia <br/ ><br>Timepoint: 2 years
- Secondary Outcome Measures
Name Time Method 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: - <br/ ><br>Complete response : increase in Hemoglobin level 2.0 g/dL above baseline, and/ or transfusion free. <br/ ><br>Partial response : increase in Hemoglobin level (1g/dL-2g/dL) above baseline <br/ ><br>Minor response : increase in Hemoglobin level ( 0.5 g/dL-1g/dL) above baseline <br/ ><br> <br/ ><br>b)Efficacy assessment with quality of life questionnaire (Functional assessment of cancer therapy- Anemia ( FACT An )) <br/ ><br>Timepoint: 2 years