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

NCT03625661 | Completed

• 1 other identifier: ICO-A-2013-07
• Study Type: interventional
• Target: 257
• Locations: 1 country
• Sites: 1

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

Conditions

Iron Deficiency Anemia

Keywords

Treatment Related Cancer,iron deficiency

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Estimation of the proportion of absolute iron deficiency

  42 months

• Estimation of the proportion of functional iron deficiency

  42 months

• Estimation of the proportion of iron deficiency as a whole

  42 months

• Estimation proportion of symptomatic anemia

  42 months

• Estimation of the proportion of asymptomatic anemia

  42 months

Study Arms (1)

Arm with Ferinject

EXPERIMENTAL

Ferinject will be administered once at inclusion

Drug: Ferinject

Interventions

Ferinject DRUG

Ferinject 50mg/ml, one injection

Also known as: carboxymaltose ferrique

Arm with Ferinject

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut Cancerologie de l'Ouest: lead

Study Sites (1)

Institut de Cancérologie de l'Ouest

Angers, 49000, France

Location

Related Publications (1)

• 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.

  PMID: 35380718 DERIVED

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

ferric carboxymaltose

Condition Hierarchy (Ancestors)

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

Study Officials

• DELPHINE CORNUAULT-FOUBERT, MD

  Institut de Cancérologie de l'Ouest

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: cohort study

Study Record Dates

• First Submitted: July 4, 2018
• First Posted: August 10, 2018
• Study Start: February 2, 2014
• Primary Completion: June 12, 2017
• Study Completion: June 12, 2017
• Last Updated: August 10, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)