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A study to compare intravenous Iron with oral iron in treatment of cancer related anaemia.

An open label, Phase III study comparing Intravenous Iron Sucrose v/s Oral Ferrous Sulphate in the treatment of cancer related anaemia.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2016/01/006520
Enrollment
192
Registered
2016-01-14
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Patients with cancer who requires chemotherapy

Interventions

Intervention1: Inj Iron Sucrose: Inj Iron Sucrose 500 mg in 250 ml 5% Dextrose Intravenous drip over 120 minutes Given twice (with cycle one and cycle two of chemotherapy.) Control Intervention1: Oral

Sponsors

Tata Memorial Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patient with cancer requiring chemotherpy 2. Hemoglobin less than or equal to 12 3. Hypochromic RBC >10%, Transferrin Saturation 4. Age > 18 yrs 5. Written Informed Consent

Exclusion criteria

Exclusion criteria: 1. Known hypersensitivity to iron therapy 2. Uncontrolled medical illness

Design outcomes

Primary

MeasureTime frame
to determine the change in Hb before and after 2 cycles of chemotherapyTimepoint: From Baseline to the end of the 3 weeks after starting the second cycle of systemic chemotherapy.

Secondary

MeasureTime frame
1. To assess Quality of life of patients for the given study period 2. To assess need for packed transfusion requirements during the study.Timepoint: 1. Every 3 weekly for 3 cycles 2. Within 2 months

Countries

India

Contacts

Public ContactDr Kumar Prabhash

CMC Vellore

drsnehal_punatar@yahoo.co.uk09833445041

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 1, 2026