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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03625661
Recruitment Status : Completed
First Posted : August 10, 2018
Last Update Posted : August 10, 2018
Sponsor:
Information provided by (Responsible Party):
Institut Cancerologie de l'Ouest

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


Condition or disease Intervention/treatment Phase
Iron Deficiency Anemia Drug: Ferinject Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 257 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: cohort study
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Impact and Evaluation of the Management of Iron Deficiency With or Without Anemia in Patients With Cancer
Actual Study Start Date : February 2, 2014
Actual Primary Completion Date : June 12, 2017
Actual Study Completion Date : June 12, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron

Arm Intervention/treatment
Experimental: Arm with Ferinject
Ferinject will be administered once at inclusion
Drug: Ferinject
Ferinject 50mg/ml, one injection
Other Name: carboxymaltose ferrique




Primary Outcome Measures :
  1. Evaluation of the quality of life of patients with iron deficiency with or without anemia during treatment for their cancer [ Time Frame: 42 months ]
    Obtained with the quality of life with the FACT-An questionnaire.


Secondary Outcome Measures :
  1. Estimation of the proportion of absolute iron deficiency [ Time Frame: 42 months ]
    Absolute iron deficiency is defined by a ferritin level <300 μg / L and a transferrin saturation coefficient <20%.

  2. Estimation of the proportion of functional iron deficiency [ Time Frame: 42 months ]
    Functional iron deficiency is defined by a ferritin level <800 μg / L and a Transferrin Saturation Coefficient <20%.

  3. Estimation of the proportion of iron deficiency as a whole [ Time Frame: 42 months ]
    Addition of proportion of iron deficiency

  4. Estimation proportion of symptomatic anemia [ Time Frame: 42 months ]
    Symptomatic anemia is defined as hemoglobin <12 g / dL associated with pallor and anoxic functional symptoms

  5. Estimation of the proportion of asymptomatic anemia [ Time Frame: 42 months ]
    Asymptomatic anemia is defined as hemoglobin <12 g / dL without clinical signs.

  6. Estimation of the proportion of anemia as a whole [ Time Frame: 42 months ]
    Addition of proportion of asymptomatic anemia and symptomatic anemia

  7. Estimation of the proportion of undernourished patients [ Time Frame: 42 months ]
    The diagnosis of malnutrition will be done by calculating BMI (<18.5 si - 70 years old and <21 from 70 years old)

  8. Estimation of the evolution of the functional capacities of the patient [ Time Frame: 42 months ]
    Estimated by functional questionnaire (Berg Balanced Scale test)

  9. Estimation of the evolution of the functional capacities of the patient [ Time Frame: 42 months ]
    Estimated by functional questionnaire (the Tinetti test)

  10. Estimation of the evolution of the functional capacities of the patient [ Time Frame: 42 months ]
    Estimated by functional questionnaire (the Timed Up and Go test)

  11. Estimation of the evolution of the functional capacities of the patient [ Time Frame: 42 months ]
    Estimated by functional questionnaire (the 6-minute walk test)

  12. Estimation of the evolution of the functional capacities of the patient [ Time Frame: 42 months ]
    Estimated by functional questionnaire (the 1-minute sit-stand test)

  13. Estimation of the evolution of the functional capacities of the patient [ Time Frame: 42 months ]
    Estimated by functional questionnaire (the climb and descent test of a staircase for 1 minute)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03625661


Locations
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France
Institut de Cancérologie de l'Ouest
Angers, France, 49000
Sponsors and Collaborators
Institut Cancerologie de l'Ouest
Investigators
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Principal Investigator: DELPHINE CORNUAULT-FOUBERT, MD Institut de cancérologie de l'Ouest
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Institut Cancerologie de l'Ouest
ClinicalTrials.gov Identifier: NCT03625661    
Other Study ID Numbers: ICO-A-2013-07
First Posted: August 10, 2018    Key Record Dates
Last Update Posted: August 10, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut Cancerologie de l'Ouest:
Treatment Related Cancer,iron deficiency
Additional relevant MeSH terms:
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Anemia
Anemia, Iron-Deficiency
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases