A study to evaluate the efficacy & safety of intravenous Ferric Carboxy Maltose in breast cancer patients with iron deficiency anemia

Not yet recruiting

• Registration Number: CTRI/2023/11/059490
• Lead Sponsor: Emcure Pharmaceuticals Ltd

Brief Summary

Breast cancer (BC) is the most frequently diagnosed cancer in women worldwide with 2.26 million [95% UI, 2.24–2.79 million] new cases in 2020. Anaemia in cancer patients is still a relevant problem and is the most common complication in them. Anaemia affects both general health and quality of life.  It has an incidence rate ranging from 22.7% to 63% and increasing to 89% following chemotherapy. It can be classified into two important forms: (1) anaemia occurring as an adverse event consequent to the toxic effect of anticancer treatment (chemotherapy-induced anaemiaâ€) and (2) anaemia occurring as a manifestation of the disease itself, more aptly called “cancer related anaemia,†resulting from systemic processes and immune system activation in cancer. Anaemia may be induced by the direct myelotoxic effect of the chemotherapeutic agents or indirectly by drug-induced renal damage resulting in low levels of erythropoietin (EPO). FCM is reported to be safe and effective in providing a rapid correction of serum ferritin levels and Hb in IDA patients. Despite the availability of several other iron formulations like LMW Iron dextran, Ferric gluconate, and Ferumoxytol, the use of FCM has improved the physical performance and quality of life in iron-deficient patients compared to other iron formulations FCM is reported to be with occurrence of less adverse events compared to other formulations. This study attempts to assess the safety and efficacy of IV FCM in increasing the Hb in IDA in Breast Cancer patients who are on follow-up and thereby decreasing eventual and inevitable blood transfusions. It will be a prospective, non-randomized, single-arm study in breast cancer patients with iron deficiency anaemia (IDA) who have completed chemotherapy and are in follow-up stage.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-02-11
• Study Start: 2023-10-11

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Females 18 yrs or older 2.
• Histologically proven diagnosis of breast cancer patients on follow-up, rather than on ongoing chemotherapy.
• Haemoglobin 8-10g/dl or transferrin saturation ≤20% regardless of the haemoglobin level.

Exclusion Criteria

• Patients with other obvious known causes of anaemia like blood loss, Megaloblastic anaemia, Pernicious anaemia, and Haemolytic anaemia 2.
• Patients who are a known case of uncontrolled hypertension, recent acute illness, hematologic disorders, or those receiving any other experimental drug 3.
• Patients with a known significant dysfunction of pulmonary, cardiovascular, endocrine, neurological, gastrointestinal, or genito-urinary systems not attributable to underlying malignancy 4.
• Patients who are receiving Iron supplements in oral or parenteral forms 5.
• Patients who are on erythropoietin stimulating agents.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the efficacy of IV Ferric CarboxyMaltose in breast cancer patients with iron deficiency anaemia	Change in the Haemoglobin level at 30±7 days from immediate preFCM Haemoglobin leve

Secondary Outcome Measures

Name	Time	Method
To determine the safety of IV Ferric CarboxyMaltose in breast cancer	patients with iron deficiency anaemia
To study the impact of IV Ferric Carboxy Maltose on the quality of life of	metastatic breast cancer patients with iron deficiency anaemia

Trial Locations

Locations (1)

Tata Memorial Centre (TMH and ACTREC); 🇮🇳 Raigarh, MAHARASHTRA, India

Tata Memorial Centre (TMH and ACTREC)

🇮🇳Raigarh, MAHARASHTRA, India

Dr Manjunath Nookala Krishnamurthy

Principal investigator

9920703438

nk.manjunath@gmail.com