Iron Supplement in the Prevention of Anemia in Female Bre... | NCT01168505

Studies
Iron Supplement in the Prevention of Anemia in Female Breast Cancer Patients

NCT01168505

Sponsor

Instituto do Cancer do Estado de São Paulo

Status

Unknown status

Last Update Posted

May 21, 2014Estimated

Enrollment

100Estimated

Phase

Phase 2

Conditions

Breast Cancer

Interventions

ferric hydroxide saccharate

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2010

Primary Completion Date

Dec 2014Estimated

Completion Date

Dec 2014Estimated

First Submitted Date

Jul 21, 2010

First Submission Date that Met QC Criteria

Jul 22, 2010

First Posted Date

Jul 23, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 20, 2014

Last Update Posted Date

May 21, 2014Estimated

Name	Class
Fundação Faculdade de Medicina	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Study to evaluate the efficacy of intravenous iron supplementation in the prevention of anemia in patients receiving (neo)adjuvant breast cancer regimens.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
no iron supplentation	No Intervention
iron supplement	Experimental		Drug: ferric hydroxide saccharate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ferric hydroxide saccharate	Drug	single dose of 200 mg (2 ampoules), 24-48 hours after administration of chemotherapy for a total of four doses	iron supplement

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	18 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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; -

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
PAULO HOFF, MD Prof.	Contact	++55-11-38932619		juliana.paula@icesp.org.br
ROBERTO ARAI, Pharm PHD	Contact	++55-11-38932619		roberto.arai@icesp.org.br

Overall Officials

Name	Affiliation	Role
Paulo Hoff, MD Professor	Instituto do Câncer do Estado de São Paulo	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Instituto Do Cancer Do Estado de São Paulo	Recruiting	São Paulo	São Paulo	01246-000	Brazil

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C013276	teferrol

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided