AnemiaPhase 4IVICANCT01701310
IVICA: Intravenous Iron in Colorectal Cancer Associated Anaemia
A Phase 4 study testing Ferric carboxymaltose and Ferrous Sulphate in people with Anemia and Colorectal Neoplasm, run by Nottingham University Hospitals NHS Trust at 8 sites in United Kingdom.
Trial summary
116 eligible patients with confirmed non-metastatic colorectal adenocarcinoma and anemia will be randomized to receive either oral ferrous sulphate (control) or intravenous ferric carboxymaltose (intervention). It is hypothesized that intravenous iron supplementation is more efficacious than oral iron therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia, Colorectal Neoplasm
- What is being tested?
- Ferric carboxymaltose and Ferrous Sulphate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 8 sitesUnited Kingdom
- Study dates
- Apr 2012to Dec 2014
- 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
- Diagnosed with histologically proven colorectal adenocarcinoma.
- Anemic at point of diagnosis of colorectal adenocarcinoma. (Haemoglobin values of <12 g/dL for males and <11 g/dL for females)
- Medically fit for surgery.
- Date of planned surgery is >14 days from date of planned initiation of intervention (intravenous ferric carboxymaltose /oral ferrous sulphate).
- Able and willing to comply with all study requirements.
- Willing to allow his/her General Practitioner and consultant, if appropriate, to be notified of participation in the study.
Who cannot join
- Female participants who are pregnant, lactating or planning a pregnancy during the course of the study.
- Previous gastric, small bowel or colorectal surgery (where ≥50% of stomach or terminal ileum has been resected)
- Current chemotherapeutic treatment.
- Known previous anaemia not attributable to colorectal carcinoma (i.e. anaemia in patients with well established inflammatory disorders or chronic renal disease).
- Known haematological disease.
- Features necessitating urgent surgery (e.g. obstructive symptoms).
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- Previous allergy to intravenous iron or related iron products.
- Significant symptomatic anemia necessitating urgent transfusion (e.g. cardiovascular compromise)
- Patients who are unable to consent.
- Significant renal or hepatic impairment.
- -Donation of blood during the study.
- Participants who have participated in another research study involving an investigational product in the past 12 weeks
- Prisoners and minors (<18 years)
- Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United Kingdom8 sites
University Hospital Birmingham
Birmingham, West Midlands, B15 2TH
University Hospitals Bristol Foundation NHS Turst
Bristol, BS2 8HW
Derby Hospital NHS Foundation Trust
Derby, DE22 3NE
St James University Hospitals NHS Trust
Leeds, LS9 7TF
University Hospitals of Leicester NHS Trust
Leicester, LE1 5WW
Nottingham University Hospitals NHS Trust
Nottingham, Nottingham, NG7 2UH
Royal Wolverhampton Hospitals NHS Trust
Wolverhampton, West Midlands, WV10 0QP
Yeovil District Hospital NHS Foundation Trust
Yeovil, BA21 4AT
About this study
Official title: An Open Label Study to Determine the Efficacy of Ferric Carboxymaltose in Preoperative Colorectal Cancer Related Anaemia, and to Develop Biomarkers to Predict Response to This Treatment Strategy
116 eligible patients with confirmed non-metastatic colorectal adenocarcinoma and anemia will be randomized to receive either oral ferrous sulphate (control) or intravenous ferric carboxymaltose (intervention).
It is hypothesized that intravenous iron supplementation is more efficacious than oral iron therapy.
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 a multi-center, randomized, open label clinical trial, which looks to investigate the efficacy of intravenous iron is in the treatment of preoperative anemia in colorectal patients. Patients will be randomized to receive intravenous ferric carboxymaltose (treatment group) or oral ferrous sulphate (control). The outcomes reviewed will include the amount and frequency of blood transfusions received, changes in patient blood profiles, patient quality of life scores, operative complications and hospital length of stay. The role of hepcidin as a biomarker of treatment response will also be assessed.
The primary hypothesis to be tested is that intravenous iron will decrease transfusion rates. To detect a significant clinical difference in blood transfused consistent with previous published data (1 unit), 58 patients will be required in each arm of the study with 90% power (alpha 0.05).
Randomization will be performed independently to the trial team using a computer generated variable block randomization program.
All data will be confidentially recorded on a Case Report Form, as will drug reactions and side effects.
- Conditions
- Anemia, Colorectal Neoplasm
- Being tested
- Ferric carboxymaltose, Ferrous Sulphate
- Keywords
- Adenocarcinoma, Anemia, Blood Transfusion, Colorectal surgery, Preoperative care, Perioperative care, Postoperative care, Iron, Hematinics, Hepcidin, Quality of life, Postoperative complications
- Medical subject headings
- Anemia, Colorectal Neoplasms, Adenocarcinoma, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferric carboxymaltoseDrug
Also called Ferinject®
A minimum of 1 dose of 1000mg of intravenous ferric carboxymaltose will be administered at least 14 days prior to the date of operation.
Ferrous SulphateDrug
(Control) 200mg twice a day of oral ferrous sulphate will be administered for a minimum of a two week period
| Study group | Role | What they receive |
|---|---|---|
| Ferric carboxymaltose | Experimental | Not described Receives: Drug: Ferric carboxymaltose |
| Ferrous Sulphate | Active comparator | Not described Receives: Drug: Ferrous Sulphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine if the use of intravenous ferric carboxymaltose can reduce the need for allogeneic blood transfusion compare to oral ferrous sulphate in patients with colorectal adenocarcinoma related anaemia
To investigate if the number of units transfused per participant, the number of participants whom receive a blood transfusion and the total number of units of blood transfused differs between the two study arms. This period monitored will begin at enrolment into the study, and cease at review in outpatient clinic 6 - 12 weeks post operatively.
Measured: 0 - 6 to 12 weeks
Secondary outcomes (5)
To determine differences in hemoglobin and hematinic markers between the groups.
Hematinic markers include ferritin, iron, transferrin, transferrin saturation, erythropoietin.
Measured: Enrollment to 6-12 weeks postoperatively
To determine differences in hepcidin levels in relation to blood profile changes in participants in the intravenous group.
To review the use of hepcidin as a biomarker to predict response to therapy.
Measured: Enrollment to 6-12 weeks postoperatively.
To determine differences in colonic mucosal expression of iron transport proteins, C-myc and NKD1 between the groups
Iron transport proteins include DMT TFR1, Ferroportin, Ferritin. As acquired from examination of pathology tissue specimen excised.
Measured: At point of operation only
To determine differences in postoperative outcomes between the groups.
Post-operative outcomes include morbidity, mortality, length of stay.
Measured: Enrollment to 6-12 weeks postoperatively
To determine differences in anemia symptomatology response between groups.
Quality of Life questionnaires will be used (SF-36[short form 36] and EQ-5D)
Measured: Enrollment to 6-12 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2012 (estimated)
- Study startApr 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nottingham University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Austin G Acheson, MBBS MD FRCS, Study chair, Nottingham University Hospitals NHS Trust, Nottingham University, School of Clinical Sciences, Division of GI Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01701310
- Sponsor's protocol ID
- 11GS005
- Other IDs
- 2011-002185-21, PB-PG-0110-21041
- Acronym
- IVICA
- Status last verified
- Oct 2016
- First submitted
- 21 Mar 2012
- Last updated
- 28 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Study to Determine the Efficacy of Ferric Carboxymaltose in Preoperative Colorectal Cancer Related Anaemia, and to Develop Biomarkers to Predict Response to This Treatment Strategy
- ClinicalTrials.gov ID
- NCT01701310
- Acronym / sponsor ID
- IVICA / 11GS005
- Conditions
- Anemia, Colorectal Neoplasm
- Keywords
- Adenocarcinoma, Anemia, Blood Transfusion, Colorectal surgery, Preoperative care, Perioperative care, Postoperative care, Iron
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Nottingham University Hospitals NHS TrustUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- Apr 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 5 Oct 2012 (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.
116 eligible patients with confirmed non-metastatic colorectal adenocarcinoma and anemia will be randomized to receive either oral ferrous sulphate (control) or intravenous ferric carboxymaltose (intervention).
It is hypothesized that intravenous iron supplementation is more efficacious than oral iron therapy.
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 a multi-center, randomized, open label clinical trial, which looks to investigate the efficacy of intravenous iron is in the treatment of preoperative anemia in colorectal patients. Patients will be randomized to receive intravenous ferric carboxymaltose (treatment group) or oral ferrous sulphate (control). The outcomes reviewed will include the amount and frequency of blood transfusions received, changes in patient blood profiles, patient quality of life scores, operative complications and hospital length of stay. The role of hepcidin as a biomarker of treatment response will also be assessed.
The primary hypothesis to be tested is that intravenous iron will decrease transfusion rates. To detect a significant clinical difference in blood transfused consistent with previous published data (1 unit), 58 patients will be required in each arm of the study with 90% power (alpha 0.05).
Randomization will be performed independently to the trial team using a computer generated variable block randomization program.
All data will be confidentially recorded on a Case Report Form, as will drug reactions and side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ferric carboxymaltose | Experimental | Drug: Ferric carboxymaltose |
| Ferrous Sulphate | Active comparator | Drug: Ferrous Sulphate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosed with histologically proven colorectal adenocarcinoma.
- Anemic at point of diagnosis of colorectal adenocarcinoma. (Haemoglobin values of <12 g/dL for males and <11 g/dL for females)
- Medically fit for surgery.
- Date of planned surgery is >14 days from date of planned initiation of intervention (intravenous ferric carboxymaltose /oral ferrous sulphate).
- Able and willing to comply with all study requirements.
Key exclusion criteria (14 listed)
- Female participants who are pregnant, lactating or planning a pregnancy during the course of the study.
- Previous gastric, small bowel or colorectal surgery (where ≥50% of stomach or terminal ileum has been resected)
- Current chemotherapeutic treatment.
- Known previous anaemia not attributable to colorectal carcinoma (i.e. anaemia in patients with well established inflammatory disorders or chronic renal disease).
- Known haematological disease.
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 |
|---|---|---|
| Ferric carboxymaltoseAlso: Ferinject®A minimum of 1 dose of 1000mg of intravenous ferric carboxymaltose will be administered at least 14 days prior to the date of operation. | Drug | Ferric carboxymaltose |
| Ferrous Sulphate(Control) 200mg twice a day of oral ferrous sulphate will be administered for a minimum of a two week period | Drug | Ferrous Sulphate |
Primary outcome
To determine if the use of intravenous ferric carboxymaltose can reduce the need for allogeneic blood transfusion compare to oral ferrous sulphate in patients with colorectal adenocarcinoma related anaemia
Time frame: 0 - 6 to 12 weeks
To investigate if the number of units transfused per participant, the number of participants whom receive a blood transfusion and the total number of units of blood transfused differs between the two study arms. This period monitored will begin at enrolment into the study, and cease at review in outpatient clinic 6 - 12 weeks post operatively.
5 secondary outcomes
To determine differences in hemoglobin and hematinic markers between the groups.
Time frame: Enrollment to 6-12 weeks postoperatively
To determine differences in hepcidin levels in relation to blood profile changes in participants in the intravenous group.
Time frame: Enrollment to 6-12 weeks postoperatively.
To determine differences in colonic mucosal expression of iron transport proteins, C-myc and NKD1 between the groups
Time frame: At point of operation only
To determine differences in postoperative outcomes between the groups.
Time frame: Enrollment to 6-12 weeks postoperatively
To determine differences in anemia symptomatology response between groups.
Time frame: Enrollment to 6-12 weeks postoperatively
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 28 Oct 2016.
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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, MBBS MD FRCS study chair
Nottingham University Hospitals NHS Trust, Nottingham University, School of Clinical Sciences, Division of GI Surgery
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ferric carboxymaltose and Ferrous Sulphate in people with Anemia and Colorectal Neoplasm, run by Nottingham University Hospitals NHS Trust at 8 sites 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 6 inclusion and 14 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 28 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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?
To determine if the use of intravenous ferric carboxymaltose can reduce the need for allogeneic blood transfusion compare to oral ferrous sulphate in patients with colorectal adenocarcinoma related anaemia (time frame: 0 - 6 to 12 weeks). 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 28 Oct 2016.