Prospective Evaluation of Iron Status in Cancer Patients Beginning Chemotherapy

NCT01968304 | Completed DMC

• 1 other identifier: 2012/18
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

Brief 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

Cancer

Keywords

Iron Status, Cancer

Outcome Measures

Primary Outcomes (1)

• ID, whether absolute or functional, shall be defined according to the recommendations contained in NCCN 2012 (NCCN - Practice Guidelines in Oncology - version 2.2012)

  Absolute ID: ferritinemia \< 30 ng/ml and saturation coefficient of transferrin \< 15%, -Functional ID: ferritinemia \< 800 ng/ml and transferrin saturation coefficient \< 20%. Prevalence shall be represented by the ratio of the number of subjects with ID at commencement of chemotherapy over the total number of subjects present in the population at the same time.

  2015, december

Secondary Outcomes (7)

• Incidence of ID during chemotherapy treatment at W6-W8 and W12-W14

  December 2015

• Changes in iron status in cancer patients receiving chemotherapy during W12-W14

  2015, december

• Determination of the proportion of patients likely to benefit from injectable iron treatment

  2015, december

• Characterization of the different iron parameters (hepcidin, chrome and soluble transferrin receptors) in order to define ID in the cancer setting

  2015, december

• Determination of the proportion of patients classified according to 4 categories (Q1,Q2,Q3,Q4) using the graph proposed by Steinmetz to assist prescribers when prescribing EPO and/or injectable iron

  2015, december

Study Arms (1)

Iron status follow up

NO INTERVENTION

Other: Iron status follow up

Interventions

Iron status follow up OTHER

Iron status follow up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged over 18 years of age.
• Patients with a locally advanced or metastatic solid cancer (breast, colorectal, prostate, ENT, and lung) scheduled to receive first-line chemotherapy for metastatic disease or Patients with a lymphoma-type hematologic cancer scheduled for first-line chemotherapy
• Patients who have read the information leaflet and have signed the informed consent.
• Patients covered by national medical insurance.

You may not qualify if:

• Patients currently undergoing chemotherapy
• Patients with diagnosed ID
• Patients having received oral iron or injectable iron treatment during the previous 3 months
• Patients unable to give their consent.
• Patients over 18 but under guardianship or public guardianship.
• Vulnerable individuals as defined by article L1121-5 to -8

Sponsors & Collaborators

• Centre Antoine Lacassagne: lead

Study Sites (1)

Centre Antoine LACASSAGNE

Nice, 06000, France

Location

Related Publications (1)

• Saint A, Viotti J, Borchiellini D, Hoch B, Raimondi V, Hebert C, Largillier R, Evesque L, Follana P, Ferrero JM, Delaby C, Schiappa R, Chamorey E, Barriere J. Iron deficiency during first-line chemotherapy in metastatic cancers: a prospective epidemiological study. Support Care Cancer. 2020 Apr;28(4):1639-1647. doi: 10.1007/s00520-019-04938-3. Epub 2019 Jul 6.

  PMID: 31278463 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Neoplasms

Study Officials

• Jérôme BARRIERE, md

  Centre Antoine Lacassagne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2013
• First Posted: October 24, 2013
• Study Start: September 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: April 1, 2016
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

FR (1)