Iron Deficiency AnemiaCAMARANCT03625661
Impact and Evaluation of the Management of Iron Deficiency With or Without Anemia in Patients With Cancer
A study testing Ferinject in people with Iron Deficiency Anemia, run by Institut Cancerologie de l'Ouest at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Iron Deficiency Anemia
- What is being tested?
- Ferinject
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 257 participants
- Where
- 1 siteFrance
- Study dates
- 2 Feb 2014to 12 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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
- Conditions
- Iron Deficiency Anemia
- Being tested
- Ferinject
- Keywords
- Treatment Related Cancer,iron deficiency
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FerinjectDrug
Also called carboxymaltose ferrique
Ferinject 50mg/ml, one injection
| Study group | Role | What they receive |
|---|---|---|
| Arm with Ferinject | Experimental | Ferinject will be administered once at inclusion Receives: Drug: Ferinject |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 42 months
Secondary outcomes (13)
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%.
Measured: 42 months
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%.
Measured: 42 months
Estimation of the proportion of iron deficiency as a whole
Addition of proportion of iron deficiency
Measured: 42 months
Estimation proportion of symptomatic anemia
Symptomatic anemia is defined as hemoglobin <12 g / dL associated with pallor and anoxic functional symptoms
Measured: 42 months
Estimation of the proportion of asymptomatic anemia
Asymptomatic anemia is defined as hemoglobin <12 g / dL without clinical signs.
Measured: 42 months
Estimation of the proportion of anemia as a whole
Addition of proportion of asymptomatic anemia and symptomatic anemia
Measured: 42 months
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)
Measured: 42 months
Estimation of the evolution of the functional capacities of the patient
Estimated by functional questionnaire (Berg Balanced Scale test)
Measured: 42 months
Estimation of the evolution of the functional capacities of the patient
Estimated by functional questionnaire (the Tinetti test)
Measured: 42 months
Estimation of the evolution of the functional capacities of the patient
Estimated by functional questionnaire (the Timed Up and Go test)
Measured: 42 months
Estimation of the evolution of the functional capacities of the patient
Estimated by functional questionnaire (the 6-minute walk test)
Measured: 42 months
Estimation of the evolution of the functional capacities of the patient
Estimated by functional questionnaire (the 1-minute sit-stand test)
Measured: 42 months
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)
Measured: 42 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2018
- Study start2 Feb 2014
- Primary completion12 Jun 2017
- Study completion12 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Iron Deficiency AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- cohort study
- Masking
- None (open label)
- Enrolment
- 257 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- DELPHINE CORNUAULT-FOUBERT, MD, Principal investigator, Institut de Cancérologie de l'Ouest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03625661
- Sponsor's protocol ID
- ICO-A-2013-07
- Acronym
- CAMARA
- Status last verified
- Jul 2018
- First submitted
- 4 Jul 2018
- Last updated
- 10 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35380718
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact and Evaluation of the Management of Iron Deficiency With or Without Anemia in Patients With Cancer
- ClinicalTrials.gov ID
- NCT03625661
- Acronym / sponsor ID
- CAMARA / ICO-A-2013-07
- Conditions
- Iron Deficiency Anemia
- Keywords
- Treatment Related Cancer,iron deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 257 participants (actual)
- Lead sponsor
- Institut Cancerologie de l'OuestUniversity, hospital or other
- Study start
- 2 Feb 2014 (actual)
- Primary completion
- 12 Jun 2017 (actual)
- Study completion
- 12 Jun 2017 (actual)
- First posted
- 10 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- cohort study
| Arm | Type | Receives |
|---|---|---|
| Arm with Ferinject | Experimental | Drug: FerinjectFerinject will be administered once at inclusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FerinjectAlso: carboxymaltose ferriqueFerinject 50mg/ml, one injection | Drug | Arm with Ferinject |
Primary outcome
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.
13 secondary outcomes
Estimation of the proportion of absolute iron deficiency
Time frame: 42 months
Estimation of the proportion of functional iron deficiency
Time frame: 42 months
Estimation of the proportion of iron deficiency as a whole
Time frame: 42 months
Estimation proportion of symptomatic anemia
Time frame: 42 months
Estimation of the proportion of asymptomatic anemia
Time frame: 42 months
Estimation of the proportion of anemia as a whole
Time frame: 42 months
Estimation of the proportion of undernourished patients
Time frame: 42 months
Estimation of the evolution of the functional capacities of the patient
Time frame: 42 months
Estimation of the evolution of the functional capacities of the patient
Time frame: 42 months
Estimation of the evolution of the functional capacities of the patient
Time frame: 42 months
Estimation of the evolution of the functional capacities of the patient
Time frame: 42 months
Estimation of the evolution of the functional capacities of the patient
Time frame: 42 months
Estimation of the evolution of the functional capacities of the patient
Time frame: 42 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2018.
- Derived from this study: PubMed 35380718Gluszak 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
DELPHINE CORNUAULT-FOUBERT, MD principal investigator
Institut de Cancérologie de l'Ouest
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ferinject in people with Iron Deficiency Anemia, run by Institut Cancerologie de l'Ouest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the quality of life of patients with iron deficiency with or without anemia during treatment for their cancer (time frame: 42 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03625661, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2018.