Impact and Evaluation of the Management of Iron Deficiency With or Without Anemia in Patients With Cancer (CAMARA)

I

Institut Cancerologie de l'Ouest

Status

Completed

Conditions

Iron Deficiency Anemia

Treatments

Drug: Ferinject

Study type

Interventional

Funder types

Other

Identifiers

NCT03625661
ICO-A-2013-07

Details and patient eligibility

About

In oncology, anemia is a frequent symptom, leading to complication of patient management for, more or less, a long term but often poorly evaluated by medical teams. In oncology, anemia is induced by multiple causes. Iron deficiency appears to be a leading cause of anemia, especially in people with solid cancer. Iron deficiency is characterized by a low level of iron . Iron is a trace element required for life. It is a major component of hemoglobin allowing the transport of oxygen in red blood cells. There are in fact 2 types of iron deficiency: an absolute iron deficiency with a deficiency of true iron and a functional iron deficiency. Since end of January 2014, intravenous iron-based injections have been reclassified for cancer patients at ICO Paul Papin. The monitoring of iron deficiency with or without anemia is currently done in our institute, the ICO-Paul Papin. There is a procedure for the management of anemia with or without iron deficiency but there is still no traceability of treatments performed, their compliance or even their impact on the rate hemoglobin and the quality of life of patients during their treatment. This observatory also makes it possible to evaluate the impact of this treatment on the quality of life of the patients and thus allows them a personalized care of the tiredness during their treatment

Full description

The study is for patients with iron deficiency and / or anemia during treatment for cancer These patients will receive ferinject. Patients will perform functional assessments and complete quality of life questionnaires, when the ferinject will be injected, then at 1 month and 6 months. Patients will be followed for 6 months in the study

Enrollment

257 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age ≥ 18 years
  • Patient with cancer regardless of the location
  • Patient with specific treatment (chemotherapy +/- targeted therapy and / or radiotherapy, hormone therapy or surgery)
  • Patient with Functional Iron Deficiency or absolute with or without anemia
  • Having given written informed consent prior to any procedure related to the study.

Exclusion criteria

  • Patient in a palliative situation not receiving specific treatment for their cancer
  • Patient is willing and able to comply with the protocol for the duration of the study including all scheduled treatment, visits and examinations
  • Patient with myeloproliferative disease
  • Contraindication to treatments for iron deficiency and / or anemia
  • Pregnant woman, parturient or nursing mothers
  • Patient has no valid health insurance
  • Disorder precluding understanding of trial information or informed consent

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

257 participants in 1 patient group

Arm with Ferinject
Experimental group
Description:
Ferinject will be administered once at inclusion
Treatment:
Drug: Ferinject

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems