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

• ClinicalTrials.gov Identifier: NCT03625661
• Recruitment Status: Completed
• First Posted: August 10, 2018
• Last Update Posted: August 10, 2018
• Sponsor: Institut Cancerologie de l'Ouest
• Information provided by (Responsible Party): Institut Cancerologie de l'Ouest

Study Description

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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)

Eligibility Criteria

• 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

Contacts and Locations

Locations

France

Institut de Cancérologie de l'Ouest

Angers, France, 49000

Sponsors and Collaborators

Institut Cancerologie de l'Ouest

Investigators

• Principal Investigator: DELPHINE CORNUAULT-FOUBERT, MD; Institut de cancérologie de l'Ouest

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Institut Cancerologie de l'Ouest
• ClinicalTrials.gov Identifier: NCT03625661
• Other Study ID Numbers: ICO-A-2013-07
• First Posted: August 10, 2018
• Last Update Posted: August 10, 2018
• Last Verified: July 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

Anemia; Anemia, Iron-Deficiency; Hematologic Diseases; Anemia, Hypochromic; Iron Metabolism Disorders; Metabolic Diseases