Will Intravenous Inron reduce blood transfusion in patients undergoing treatment for ovarian cancer

Phase 3

Completed

• Conditions: Malignant neoplasm of unspecifiedovary,

• Registration Number: CTRI/2019/05/019378
• Lead Sponsor: Amrita University

Brief Summary

This study is planned as a prospective randomised controlled trial to evaluate the efficacy of parenteral iron supplementation using ferric carboy maltose in patients undergoing treatment (chemotherapy/ surgery) for epithelial ovarian cancer. 30 patients each will be included in the interventional and control arm. the intervention group will receive parenteral iron if the haemoglobin is less than 10gm%. The control group will be treated with oral iron. Primary outcomes measured will be improvement in haemoglobin and number of units of blood transfused.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-17
• Study Completion: 2021-01-09
• Last Update Posted: 2024-04-15

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

age 18–75 years with normal liver and kidney function, no prior radiotherapy and an Eastern Cooperative Oncology Group (ECOG) performance status of ≤2 -Patient with epithelial ovarian cancer receiving Neoadjuvant or adjuvant chemotherapy or planned for surgery , having Hemoglobin level ≤10 gm/dL.

Exclusion Criteria

• Erythropoitin Stimulating Agent administration during chemotherapy course -Allergic reaction to ferric carboxymaltose.
• Serum ferritin >800 ng/mL OR serum trasferrin saturation >50%.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in haemoglobin	At three months | Completion of chemotherapy
Reduction in Blood transfusion	At three months | Completion of chemotherapy

Secondary Outcome Measures

Name	Time	Method
Improvemnet in Serum ferritin, Serum Iron levels and Total Iron Binding capacity	3 months, 6 months

Trial Locations

Locations (1)

Amrita Institute of Medical Sciences; 🇮🇳 Ernakulam, KERALA, India

Amrita Institute of Medical Sciences

🇮🇳Ernakulam, KERALA, India

Anupama R

Principal investigator

8891728600

anupamashyam@gmail.com