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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

Not Applicable
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
Inclusion Criteria

Hemoglobin level less than or equal to 10 g/dL

- Transferrin saturation < 20 %

- Any stage solid malignancies

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

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Prevalence of patients with absolute and functional iron deficiency anemia <br/ ><br>Timepoint: 2 years
Secondary Outcome Measures
NameTimeMethod
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
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