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Completed

NCT Number: NCT03625661

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

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

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Key information

Conditions

Iron Deficiency Anemia Anemia Anemia, Hypochromic Anemia, Iron-Deficiency Hematologic Diseases Hemic and Lymphatic Diseases Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut de Cancérologie de l'Ouest

Angers, 49000, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ferinject

Drug

Ferinject 50mg/ml, one injection

Other names: carboxymaltose ferrique

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Institut Cancerologie de l'Ouest

Other

Registry information

Acronym: CAMARA

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Aug 10, 2018
Registry last updated
Aug 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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