Breast CancerPhase 2NCT01168505
Iron Supplement in the Prevention of Anemia in Female Breast Cancer Patients
A Phase 2 study testing ferric hydroxide saccharate in people with Breast Cancer, run by Instituto do Cancer do Estado de São Paulo at 2 sites in Brazil.
Trial summary
Study to evaluate the efficacy of intravenous iron supplementation in the prevention of anemia in patients receiving (neo)adjuvant breast cancer regimens. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- ferric hydroxide saccharate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesBrazil
- Study dates
- May 2010to Dec 2014
- Phase
- Phase 2
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women older than 18 years
- Patient with operated breast cancer with indication for (NEO)adjuvant therapy
- They must have hemoglobin levels within the normal range (> 12g/dL), absence of renal and hepatic dysfunction as assessed by serum levels of urea, creatinine, AST, ALT.
- Lack of folic acid deficiency and vitamin B12
- Able to provide written informed consent.
Who cannot join
- Use of any oral supplement containing iron;
- Patients who have iron overload as defined by serum ferritin> 800 microg / L or transferrin saturation> 40%;
- Patients who are pregnant or breastfeeding;
- History of active infection or active bleeding except menstruation;
- History of HIV or hepatitis B or C - clinically important; -
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites, 2 recruiting
- Recruiting
Instituto Do Cancer Do Estado de São Paulo
São Paulo, São Paulo, 01246-000
MAX MANO, MD PHD, 55-11-38932646, elaine.longo@icesp.org.br
Aknar Calabrich, MD
- Recruiting
Hospital Sirio Libanes
São Paulo, São Paulo, 01308-000
PAULO HOFF, MD, ++55-11-3155-0995, rosana.batista@hsl.org.br
PAULO HOFF, MD
About this study
Official title: The Role of Intravenous Iron to Prevent Anemia in Women With Breast Cancer Receiving (Neo)Adjuvant Chemotherapy
Study to evaluate the efficacy of intravenous iron supplementation in the prevention of anemia in patients receiving (neo)adjuvant breast cancer regimens.
- Conditions
- Breast Cancer
- Being tested
- ferric hydroxide saccharate
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ferric hydroxide saccharateDrug
Also called NORIPURUM
single dose of 200 mg (2 ampoules), 24-48 hours after administration of chemotherapy for a total of four doses
| Study group | Role | What they receive |
|---|---|---|
| no iron supplentation | No intervention | Not described |
| iron supplement | Experimental | Not described Receives: Drug: ferric hydroxide saccharate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the efficacy of intravenous iron supplementation in the prevention of anemia in patients receiving (neo)adjuvant breast cancer regimens
Anemia prevention defined by hemoglobin levels
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2010 (estimated)
- Study startMay 2010
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto do Cancer do Estado de São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação Faculdade de Medicina
- Responsible party
- Sponsor
- Investigators
- Paulo Hoff, MD Professor, Principal investigator, Instituto do Câncer do Estado de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01168505
- Sponsor's protocol ID
- NP 002/2009 - CEP 543/09
- Status last verified
- May 2014
- First submitted
- 21 Jul 2010
- Last updated
- 21 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Intravenous Iron to Prevent Anemia in Women With Breast Cancer Receiving (Neo)Adjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT01168505
- Acronym / sponsor ID
- NP 002/2009 - CEP 543/09
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Instituto do Cancer do Estado de São PauloUniversity, hospital or other
- Collaborators
- Fundação Faculdade de Medicina
- Study start
- May 2010
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 23 Jul 2010 (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.
Study to evaluate the efficacy of intravenous iron supplementation in the prevention of anemia in patients receiving (neo)adjuvant breast cancer regimens.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| no iron supplentation | No intervention | – |
| iron supplement | Experimental | Drug: ferric hydroxide saccharate |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women older than 18 years
- Patient with operated breast cancer with indication for (NEO)adjuvant therapy
- They must have hemoglobin levels within the normal range (> 12g/dL), absence of renal and hepatic dysfunction as assessed by serum levels of urea, creatinine, AST, ALT.
- Lack of folic acid deficiency and vitamin B12
- Able to provide written informed consent.
Key exclusion criteria (5 listed)
- Use of any oral supplement containing iron;
- Patients who have iron overload as defined by serum ferritin> 800 microg / L or transferrin saturation> 40%;
- Patients who are pregnant or breastfeeding;
- History of active infection or active bleeding except menstruation;
- History of HIV or hepatitis B or C - clinically important; -
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 hydroxide saccharateAlso: NORIPURUMsingle dose of 200 mg (2 ampoules), 24-48 hours after administration of chemotherapy for a total of four doses | Drug | iron supplement |
Primary outcome
Evaluate the efficacy of intravenous iron supplementation in the prevention of anemia in patients receiving (neo)adjuvant breast cancer regimens
Time frame: 18 weeks
Anemia prevention defined by hemoglobin levels
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 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.
Paulo Hoff, MD Professor principal investigator
Instituto do Câncer do Estado de São Paulo
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ferric hydroxide saccharate in people with Breast Cancer, run by Instituto do Cancer do Estado de São Paulo at 2 sites in Brazil.
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 5 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: status not confirmed, as of the sponsor's last update on 21 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact PAULO HOFF, MD Prof. (++55-11-38932619, juliana.paula@icesp.org.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the efficacy of intravenous iron supplementation in the prevention of anemia in patients receiving (neo)adjuvant breast cancer regimens (time frame: 18 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 21 May 2014.