Colorectal NeoplasmPhase 4NCT02057471
Intravenous Iron: Measuring Response in Anemic Surgical Patients
A Phase 4 study testing Intravenous ferric carboxymaltose in people with Colorectal Neoplasm and Anemia, run by Nottingham University Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
20 Patients will be recruited with confirmed colorectal adenocarcinoma and anemia who are planned to undergo surgery. All patients will be treated with a single dose of 1g intravenous ferric carboxymaltose (FERINJECT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasm, Anemia
- What is being tested?
- Intravenous ferric carboxymaltose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2009to Mar 2012
- Phase
- Phase 4
- 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
- Diagnosed with colonic or rectal adenocarcinoma
- Defined date of operation at least 14 days from recruitment to study
- Confirmed anemia
- Females of child bearing age must agree to use a medically accepted form of contraceptive
Who cannot join
- Patient's who are unable to consent
- Recognized allergy or intolerance of the study drug or excipients
- Patients with previous or current hematological disease that in the investigators' opinion would confound the diagnosis of anemia
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Nottingham University Hospitals NHS Trust
Nottingham, Nottinghamshire, NG7 2UH
About this study
Official title: An Open Label Study of Intravenous Iron (FERINJECT) in Colorectal Adenocarcinoma Related Anaemia to Identify Potential Biomarkers of Responsiveness to Intravenous Iron
20 Patients will be recruited with confirmed colorectal adenocarcinoma and anemia who are planned to undergo surgery. All patients will be treated with a single dose of 1g intravenous ferric carboxymaltose (FERINJECT).
It is hypothesized that intravenous iron supplementation is efficacious at raising haemoglobin levels and reduced blood transfusion requirements.
Read the detailed description
Patients who are anemic at the time of operation have been shown to have an increased frequency of complications including wound infection and longer post-operative admissions. Similarly, patients who are anemic at the time of their cancer operation are more likely to require a blood transfusion which may increase the risk of recurrence of the cancer.
At present, oral iron is often used to treat anemia preoperatively in an attempt to minimize the risk above. This drug is often poorly tolerated due to the side effect profile. Blood transfusions can also be administered but expose the patient to other risks including infection and transfusion associated reactions. In order to overcome these issues, intravenous iron preparations have been developed and have improved in safety.
This is open label clinical trial, which looks to investigate the efficacy of intravenous iron is in the treatment of preoperative anemia in colorectal patients. The outcomes reviewed will include the amount and frequency of blood transfusions received, changes in patient blood profiles operative complications and hospital length of stay. The role of hepcidin as a biomarker of treatment response will also be assessed.
All data will be confidentially recorded on a Case Report Form, as will drug reactions and side effects.
- Conditions
- Colorectal Neoplasm, Anemia
- Being tested
- Intravenous ferric carboxymaltose
- Keywords
- Adenocarcinoma, Anemia, Blood Transfusion, Colorectal surgery, Preoperative care, Perioperative care, Postoperative care, Iron, Hematinics, Hepcidin, Quality of life, Postoperative complications
- Medical subject headings
- Colorectal Neoplasms, Anemia, Adenocarcinoma, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous ferric carboxymaltoseDrug
Also called FERINJECT
1 gram intravenous ferric carboxymaltose (FERINJECT) will be administered to all patients within the study
| Study group | Role | What they receive |
|---|---|---|
| Intravenous Ferric Carboxymaltose | Experimental | All recruited patients will be allocated to this treatment. 1 gram of Ferric carboxymaltose (FERINJECT) to be given at recruitment Receives: Drug: Intravenous ferric carboxymaltose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients transfused allogenic red blood cells
To determine if the administration of intravenous iron reduces the number of expected allogenic red blood cell transfusions from recruitment to the perioperative phase
Measured: Patients will be followed from recruitment to the study until postoperative discharge from hospital, which will be an expected average of 4 weeks
Hemoglobin levels
To determine if intravenous iron significantly increases hemoglobin levels in the preoperative optimization of patients
Measured: Patients will be followed from recruitment to the study until 8 weeks post operatively, which will be an expected average of 10 weeks
Secondary outcomes (5)
Hepcidin levels
To monitor changes in hepcidin in response to treatment and review if this can predict response to intravenous iron therapy
Measured: Patients will be followed from recruitment to the study until the day after surgery, which will be an expected average of 3 weeks
Erythropoietin levels
To monitor changes in Erythropoietin in response to treatment and review if this can predict response to intravenous iron therapy
Measured: Patients will be followed from recruitment to the study until 8 weeks post operatively, which will be an expected average of 10 weeks
Transferrin saturation levels
To monitor changes in transferrin saturation levels in response to treatment and review if this can predict response to intravenous iron therapy
Measured: Patients will be followed from recruitment to the study until 8 weeks post operatively, which will be an expected average of 10 weeks
Ferritin levels
To monitor changes in ferritin levels in response to treatment and review if this can predict response to intravenous iron therapy
Measured: Patients will be followed from recruitment to the study until 8 weeks post operatively, which will be an expected average of 10 weeks
C Reactive Protein levels
To monitor changes in C Reactive Protein levels over the course of the study, and review if this can predict response to intravenous iron therapy, or is associated with changes in hepcidin
Measured: Patients will be followed from recruitment to the study until 8 weeks post operatively, which will be an expected average of 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2014 (estimated)
- Study startSep 2009
- Primary completionJan 2011
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nottingham University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Austin G Acheson, MD FRCS, Study chair, Nottingham University Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02057471
- Sponsor's protocol ID
- 09GS002
- Other IDs
- 2009-011382-80, 2009
- Status last verified
- Feb 2014
- First submitted
- 3 Feb 2014
- Last updated
- 7 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Study of Intravenous Iron (FERINJECT) in Colorectal Adenocarcinoma Related Anaemia to Identify Potential Biomarkers of Responsiveness to Intravenous Iron
- ClinicalTrials.gov ID
- NCT02057471
- Acronym / sponsor ID
- 09GS002
- Conditions
- Colorectal Neoplasm, Anemia
- Keywords
- Adenocarcinoma, Anemia, Blood Transfusion, Colorectal surgery, Preoperative care, Perioperative care, Postoperative care, Iron
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Nottingham University Hospitals NHS TrustUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 7 Feb 2014 (estimated)
- 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.
20 Patients will be recruited with confirmed colorectal adenocarcinoma and anemia who are planned to undergo surgery. All patients will be treated with a single dose of 1g intravenous ferric carboxymaltose (FERINJECT).
It is hypothesized that intravenous iron supplementation is efficacious at raising haemoglobin levels and reduced blood transfusion requirements.
Detailed description
Patients who are anemic at the time of operation have been shown to have an increased frequency of complications including wound infection and longer post-operative admissions. Similarly, patients who are anemic at the time of their cancer operation are more likely to require a blood transfusion which may increase the risk of recurrence of the cancer.
At present, oral iron is often used to treat anemia preoperatively in an attempt to minimize the risk above. This drug is often poorly tolerated due to the side effect profile. Blood transfusions can also be administered but expose the patient to other risks including infection and transfusion associated reactions. In order to overcome these issues, intravenous iron preparations have been developed and have improved in safety.
This is open label clinical trial, which looks to investigate the efficacy of intravenous iron is in the treatment of preoperative anemia in colorectal patients. The outcomes reviewed will include the amount and frequency of blood transfusions received, changes in patient blood profiles operative complications and hospital length of stay. The role of hepcidin as a biomarker of treatment response will also be assessed.
All data will be confidentially recorded on a Case Report Form, as will drug reactions and side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intravenous Ferric Carboxymaltose | Experimental | Drug: Intravenous ferric carboxymaltoseAll recruited patients will be allocated to this treatment. 1 gram of Ferric carboxymaltose (FERINJECT) to be given at recruitment |
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
- Diagnosed with colonic or rectal adenocarcinoma
- Defined date of operation at least 14 days from recruitment to study
- Confirmed anemia
- Females of child bearing age must agree to use a medically accepted form of contraceptive
Key exclusion criteria (3 listed)
- Patient's who are unable to consent
- Recognized allergy or intolerance of the study drug or excipients
- Patients with previous or current hematological disease that in the investigators' opinion would confound the diagnosis of anemia
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 |
|---|---|---|
| Intravenous ferric carboxymaltoseAlso: FERINJECT1 gram intravenous ferric carboxymaltose (FERINJECT) will be administered to all patients within the study | Drug | Intravenous Ferric Carboxymaltose |
Primary outcome
Number of patients transfused allogenic red blood cells
Time frame: Patients will be followed from recruitment to the study until postoperative discharge from hospital, which will be an expected average of 4 weeks
To determine if the administration of intravenous iron reduces the number of expected allogenic red blood cell transfusions from recruitment to the perioperative phase
Hemoglobin levels
Time frame: Patients will be followed from recruitment to the study until 8 weeks post operatively, which will be an expected average of 10 weeks
To determine if intravenous iron significantly increases hemoglobin levels in the preoperative optimization of patients
5 secondary outcomes
Hepcidin levels
Time frame: Patients will be followed from recruitment to the study until the day after surgery, which will be an expected average of 3 weeks
Erythropoietin levels
Time frame: Patients will be followed from recruitment to the study until 8 weeks post operatively, which will be an expected average of 10 weeks
Transferrin saturation levels
Time frame: Patients will be followed from recruitment to the study until 8 weeks post operatively, which will be an expected average of 10 weeks
Ferritin levels
Time frame: Patients will be followed from recruitment to the study until 8 weeks post operatively, which will be an expected average of 10 weeks
C Reactive Protein levels
Time frame: Patients will be followed from recruitment to the study until 8 weeks post operatively, which will be an expected average of 10 weeks
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 7 Feb 2014.
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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.
Austin G Acheson, MD FRCS study chair
Nottingham University Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intravenous ferric carboxymaltose in people with Colorectal Neoplasm and Anemia, run by Nottingham University Hospitals NHS Trust at 1 site in United Kingdom.
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 3 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 7 Feb 2014. 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 United Kingdom. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Number of patients transfused allogenic red blood cells (time frame: Patients will be followed from recruitment to the study until postoperative discharge from hospital, which will be an expected average of 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Feb 2014.