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

Iron Deficiency Anemia Clinical Trial

— CAMARA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03625661
• Other study ID #: ICO-A-2013-07
• Status: Completed
• Phase: N/A
• Start date: February 2, 2014
• Est. completion date: June 12, 2017

Study information

• Verified date: July 2018
• Source: Institut Cancerologie de l'Ouest
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 257
• Est. completion date: June 12, 2017
• Est. primary completion date: June 12, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Iron Deficiency Anemia

Intervention

Drug:
• Ferinject
Ferinject 50mg/ml, one injection

Locations

Country	Name	City	State
France	Institut de Cancérologie de l'Ouest	Angers

Sponsors (1)

Lead Sponsor	Collaborator
Institut Cancerologie de l'Ouest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the quality of life of patients with iron deficiency with or without anemia during treatment for their cancer	Obtained with the quality of life with the FACT-An questionnaire.	42 months
Secondary	Estimation of the proportion of absolute iron deficiency	Absolute iron deficiency is defined by a ferritin level <300 µg / L and a transferrin saturation coefficient <20%.	42 months
Secondary	Estimation of the proportion of functional iron deficiency	Functional iron deficiency is defined by a ferritin level <800 µg / L and a Transferrin Saturation Coefficient <20%.	42 months
Secondary	Estimation of the proportion of iron deficiency as a whole	Addition of proportion of iron deficiency	42 months
Secondary	Estimation proportion of symptomatic anemia	Symptomatic anemia is defined as hemoglobin <12 g / dL associated with pallor and anoxic functional symptoms	42 months
Secondary	Estimation of the proportion of asymptomatic anemia	Asymptomatic anemia is defined as hemoglobin <12 g / dL without clinical signs.	42 months
Secondary	Estimation of the proportion of anemia as a whole	Addition of proportion of asymptomatic anemia and symptomatic anemia	42 months
Secondary	Estimation of the proportion of undernourished patients	The diagnosis of malnutrition will be done by calculating BMI (<18.5 si - 70 years old and <21 from 70 years old)	42 months
Secondary	Estimation of the evolution of the functional capacities of the patient	Estimated by functional questionnaire (Berg Balanced Scale test)	42 months
Secondary	Estimation of the evolution of the functional capacities of the patient	Estimated by functional questionnaire (the Tinetti test)	42 months
Secondary	Estimation of the evolution of the functional capacities of the patient	Estimated by functional questionnaire (the Timed Up and Go test)	42 months
Secondary	Estimation of the evolution of the functional capacities of the patient	Estimated by functional questionnaire (the 6-minute walk test)	42 months
Secondary	Estimation of the evolution of the functional capacities of the patient	Estimated by functional questionnaire (the 1-minute sit-stand test)	42 months
Secondary	Estimation of the evolution of the functional capacities of the patient	Estimated by functional questionnaire (the climb and descent test of a staircase for 1 minute)	42 months