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Prospective Evaluation of Iron Status in Cancer Patients Beginning Chemotherapy

NCT01968304 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 480

Last updated 2026-04-23

No results posted yet for this study

Summary

In cancerology, anemia is a frequently-found situation, with a prevalence ranging from 30% to 90%, according to the series, disease stages, primary tumor locations and age (Scotte, Launay-Vacher et al. 2012). Although very probably a major cause of anemia, iron deficiency (ID) has been seldom investigated in the field of cancer. Its prevalence and incidence have never been assessed in a prospective study. It is well-known that anemia in the cancer setting is a source of asthenia and deterioration of quality of life, and can even reduce the efficacy of anticancer treatments such as radiotherapy. Correcting anemia therefore constitutes a daily challenge. Before 2004-2005, a very large proportion of patients were treated with erythropoietin (EPO). However, prescriptions for EPO appear to have considerably declined since the warnings issued by various scientific societies and governments on account of the possible increase in death rates and a higher incidence of thromboembolic events, as reported in 8 studies published to date (NCCN 2012). Simultaneously, the transfusion rate augmented from 3.4% to 8.7% and the median hemoglobin level fell from 10.8 to 8.9 g/dL (Feinberg, Bruno et al. 2012). The use of injectable iron appears to have improved the correction of anemia by EPO, as reported in several concordant studies versus oral iron and placebo (Pedrazzoli, Rosti et al. 2009; Steensma, Sloan et al. 2011). However, no monotherapy study has been conducted to evaluate the impact of injectable iron, alone without EPO, for the correction of ID (with or without anemia) in cancer treatment. Consequently, there exists a wide variety of practices, with an injectable iron prescription rate which, a priori, does not match the number of patients with iron deficiency. There exist other iron-based parameters to characterize ID but these are not yet used routinely during chemotherapy and need to be validated in the cancer field.

These parameters include:

* An assay of reticulocyte hemoglobin content (rHC)
* An assay of soluble transferrin receptor (sTfR) Soluble transferrin receptors are mainly located on red blood line cells receiving iron delivered by transferrin.

In this study, we propose to make a prospective assessment of the iron status of cancer patients beginning chemotherapy. The aim is to determine the proportion of patients who might benefit from injectable iron treatment. All ID will be covered prospectively over a 2-year period.

Conditions

Interventions

OTHER

Iron status follow up

Sponsors & Collaborators

  • Centre Antoine Lacassagne

    lead OTHER

Principal Investigators

  • Jérôme BARRIERE, md · Centre Antoine Lacassagne

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2015-12-31
Completion
2016-04-30

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01968304 on ClinicalTrials.gov