Impact and Evaluation of the Management of Iron Deficiency With or Without Anemia in Patients With Cancer (CAMARA)
Primary Purpose
Iron Deficiency Anemia
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Ferinject
Sponsored by
About this trial
This is an interventional supportive care trial for Iron Deficiency Anemia focused on measuring Treatment Related Cancer,iron deficiency
Eligibility 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
Sites / Locations
- Institut de Cancérologie de l'Ouest
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arm with Ferinject
Arm Description
Ferinject will be administered once at inclusion
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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%.
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%.
Estimation of the proportion of iron deficiency as a whole
Addition of proportion of iron deficiency
Estimation proportion of symptomatic anemia
Symptomatic anemia is defined as hemoglobin <12 g / dL associated with pallor and anoxic functional symptoms
Estimation of the proportion of asymptomatic anemia
Asymptomatic anemia is defined as hemoglobin <12 g / dL without clinical signs.
Estimation of the proportion of anemia as a whole
Addition of proportion of asymptomatic anemia and symptomatic anemia
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)
Estimation of the evolution of the functional capacities of the patient
Estimated by functional questionnaire (Berg Balanced Scale test)
Estimation of the evolution of the functional capacities of the patient
Estimated by functional questionnaire (the Tinetti test)
Estimation of the evolution of the functional capacities of the patient
Estimated by functional questionnaire (the Timed Up and Go test)
Estimation of the evolution of the functional capacities of the patient
Estimated by functional questionnaire (the 6-minute walk test)
Estimation of the evolution of the functional capacities of the patient
Estimated by functional questionnaire (the 1-minute sit-stand test)
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)
Full Information
NCT ID
NCT03625661
First Posted
July 4, 2018
Last Updated
August 9, 2018
Sponsor
Institut Cancerologie de l'Ouest
1. Study Identification
Unique Protocol Identification Number
NCT03625661
Brief Title
Impact and Evaluation of the Management of Iron Deficiency With or Without Anemia in Patients With Cancer
Acronym
CAMARA
Official Title
Impact and Evaluation of the Management of Iron Deficiency With or Without Anemia in Patients With Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
February 2, 2014 (Actual)
Primary Completion Date
June 12, 2017 (Actual)
Study Completion Date
June 12, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Cancerologie de l'Ouest
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron Deficiency Anemia
Keywords
Treatment Related Cancer,iron deficiency
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
cohort study
Masking
None (Open Label)
Allocation
N/A
Enrollment
257 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm with Ferinject
Arm Type
Experimental
Arm Description
Ferinject will be administered once at inclusion
Intervention Type
Drug
Intervention Name(s)
Ferinject
Other Intervention Name(s)
carboxymaltose ferrique
Intervention Description
Ferinject 50mg/ml, one injection
Primary Outcome Measure Information:
Title
Evaluation of the quality of life of patients with iron deficiency with or without anemia during treatment for their cancer
Description
Obtained with the quality of life with the FACT-An questionnaire.
Time Frame
42 months
Secondary Outcome Measure Information:
Title
Estimation of the proportion of absolute iron deficiency
Description
Absolute iron deficiency is defined by a ferritin level <300 μg / L and a transferrin saturation coefficient <20%.
Time Frame
42 months
Title
Estimation of the proportion of functional iron deficiency
Description
Functional iron deficiency is defined by a ferritin level <800 μg / L and a Transferrin Saturation Coefficient <20%.
Time Frame
42 months
Title
Estimation of the proportion of iron deficiency as a whole
Description
Addition of proportion of iron deficiency
Time Frame
42 months
Title
Estimation proportion of symptomatic anemia
Description
Symptomatic anemia is defined as hemoglobin <12 g / dL associated with pallor and anoxic functional symptoms
Time Frame
42 months
Title
Estimation of the proportion of asymptomatic anemia
Description
Asymptomatic anemia is defined as hemoglobin <12 g / dL without clinical signs.
Time Frame
42 months
Title
Estimation of the proportion of anemia as a whole
Description
Addition of proportion of asymptomatic anemia and symptomatic anemia
Time Frame
42 months
Title
Estimation of the proportion of undernourished patients
Description
The diagnosis of malnutrition will be done by calculating BMI (<18.5 si - 70 years old and <21 from 70 years old)
Time Frame
42 months
Title
Estimation of the evolution of the functional capacities of the patient
Description
Estimated by functional questionnaire (Berg Balanced Scale test)
Time Frame
42 months
Title
Estimation of the evolution of the functional capacities of the patient
Description
Estimated by functional questionnaire (the Tinetti test)
Time Frame
42 months
Title
Estimation of the evolution of the functional capacities of the patient
Description
Estimated by functional questionnaire (the Timed Up and Go test)
Time Frame
42 months
Title
Estimation of the evolution of the functional capacities of the patient
Description
Estimated by functional questionnaire (the 6-minute walk test)
Time Frame
42 months
Title
Estimation of the evolution of the functional capacities of the patient
Description
Estimated by functional questionnaire (the 1-minute sit-stand test)
Time Frame
42 months
Title
Estimation of the evolution of the functional capacities of the patient
Description
Estimated by functional questionnaire (the climb and descent test of a staircase for 1 minute)
Time Frame
42 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
DELPHINE CORNUAULT-FOUBERT, MD
Organizational Affiliation
Institut de Cancérologie de l'Ouest
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut de Cancérologie de l'Ouest
City
Angers
ZIP/Postal Code
49000
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35380718
Citation
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.
Results Reference
derived
Learn more about this trial
Impact and Evaluation of the Management of Iron Deficiency With or Without Anemia in Patients With Cancer
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