Clinical trial NCT01968304: Prospective Evaluation of Iron Status in Cancer Patients Beginning Chemotherapy
Official title: Prospective Evaluation of Iron Status in Cancer Patients Beginning Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: Iron Status, Cancer
Lead sponsor: Centre Antoine Lacassagne
Sponsor class: OTHER
First posted: 2013-10-24
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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.

Detailed description: Predictable risks The study will involve no increased risk or additional discomfort. Blood samples used in the study will be taken at blood samplings scheduled by the hospital practice of the reference institution. Only small amounts of blood will be taken for this study and they will have no repercussion on the patient's general status.

Evaluation of the expected results Improved knowledge of ID epidemiology in patients receiving chemotherapy would enable more effective targeting of potential patients specifically requiring management by injectable iron.

Expected benefits

Through the medium of this study :

* We hope to optimize ID screening, increase our knowledge of ID characteristics and enhance patient management.
* Management of anemia in the cancer setting could thus be modified, i.e. via injectable iron treatment involving no EPO, the dangers of which (increase in the number of thromboembolic events, and even its potentially negative impact on survival) are being more and more fully documented.
* Patients included in this study will benefit from the detection of ID, which otherwise would not have been discovered.

Eligibility criteria: Inclusion Criteria:

1. Patients aged over 18 years of age.
2. 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
3. Patients who have read the information leaflet and have signed the informed consent.
4. Patients covered by national medical insurance.

Exclusion Criteria:

1. Patients currently undergoing chemotherapy
2. Patients with diagnosed ID
3. Patients having received oral iron or injectable iron treatment during the previous 3 months
4. Patients receiving EPO or transfused during the 3 months prior to inclusion.
5. Patients unable to give their consent.
6. Patients over 18 but under guardianship or public guardianship.
7. Vulnerable individuals as defined by article L1121-5 to -8

Primary outcomes:
measure: ID, whether absolute or functional, shall be defined according to the recommendations contained in NCCN 2012 (NCCN - Practice Guidelines in Oncology - version 2.2012)
timeFrame: 2015, december
Secondary outcomes:
measure: Incidence of ID during chemotherapy treatment at W6-W8 and W12-W14
timeFrame: December 2015
measure: Changes in iron status in cancer patients receiving chemotherapy during W12-W14
timeFrame: 2015, december
measure: Determination of the proportion of patients likely to benefit from injectable iron treatment
timeFrame: 2015, december
measure: Characterization of the different iron parameters (hepcidin, chrome and soluble transferrin receptors) in order to define ID in the cancer setting
timeFrame: 2015, december
measure: 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
timeFrame: 2015, december
measure: Determination of cancer pathologies and/or treatments predictive of occurrence of ID
timeFrame: 2015, december
measure: Determination of the existence of a correlation between response to chemotherapy treatment and the presence of ID
timeFrame: 2015, december
Other outcomes:
Locations:
city: Nice
country: France
facility: Centre Antoine LACASSAGNE
Study officials:
affiliation: Centre Antoine Lacassagne
name: Jérôme BARRIERE, md
role: PRINCIPAL_INVESTIGATOR
References: