Clinical trial NCT03625661: Impact and Evaluation of the Management of Iron Deficiency With or Without Anemia in Patients With Cancer
Official title: Impact and Evaluation of the Management of Iron Deficiency With or Without Anemia in Patients With Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iron Deficiency Anemia
Keywords: Treatment Related Cancer,iron deficiency
Lead sponsor: Institut Cancerologie de l'Ouest
Sponsor class: OTHER
First posted: 2018-08-10
Enrollment: 257
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: cohort study
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of the quality of life of patients with iron deficiency with or without anemia during treatment for their cancer
timeFrame: 42 months
Secondary outcomes:
measure: Estimation of the proportion of absolute iron deficiency
timeFrame: 42 months
measure: Estimation of the proportion of functional iron deficiency
timeFrame: 42 months
measure: Estimation of the proportion of iron deficiency as a whole
timeFrame: 42 months
measure: Estimation proportion of symptomatic anemia
timeFrame: 42 months
measure: Estimation of the proportion of asymptomatic anemia
timeFrame: 42 months
measure: Estimation of the proportion of anemia as a whole
timeFrame: 42 months
measure: Estimation of the proportion of undernourished patients
timeFrame: 42 months
measure: Estimation of the evolution of the functional capacities of the patient
timeFrame: 42 months
measure: Estimation of the evolution of the functional capacities of the patient
timeFrame: 42 months
measure: Estimation of the evolution of the functional capacities of the patient
timeFrame: 42 months
measure: Estimation of the evolution of the functional capacities of the patient
timeFrame: 42 months
measure: Estimation of the evolution of the functional capacities of the patient
timeFrame: 42 months
measure: Estimation of the evolution of the functional capacities of the patient
timeFrame: 42 months
Other outcomes:
Locations:
city: Angers
country: France
facility: Institut de Cancérologie de l'Ouest
Study officials:
affiliation: Institut de Cancérologie de l'Ouest
name: DELPHINE CORNUAULT-FOUBERT, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gluszak C, de Vries-Brilland M, Seegers V, Baroin C, Kieffer H, Delva R, Cornuault-Foubert D. Impact of Iron-Deficiency Management on Quality of Life in Patients with Cancer: A Prospective Cohort Study (CAMARA Study). Oncologist. 2022 Apr 5;27(4):328-333. doi: 10.1093/oncolo/oyac005.