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Trial registered on ANZCTR


Registration number
ACTRN12610000813088
Ethics application status
Approved
Date submitted
18/09/2010
Date registered
29/09/2010
Date last updated
29/09/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of perioperative Recombinant Human Erythropoietin administration on proinflammatory cascade following breast cancer surgery.
Scientific title
A double blinded, randomized, placebo controlled study on the effects of Recombinant Human Erythropoietin on proinflammatory cytokines expression following modified radical mastectomy in females with breast cancer stage II/III
Secondary ID [1] 252716 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Female subjects with breast cancer stage II/III undergoing a modified radical mastectomy 258209 0
Condition category
Condition code
Cancer 258387 258387 0 0
Breast
Inflammatory and Immune System 258419 258419 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study group: subcutaneous perioperative administration of Recombinant Human Erythropoietin (10000IU/day, subcutaneously) for 9 preoperative and 2 postoperative days
Also all patients recieved oral iron supplementation (200mg/day) for 9 preoperative and 2 postoperative days
Intervention code [1] 257224 0
Treatment: Drugs
Comparator / control treatment
Control group:subcutaneous perioperative administration of placebo subcutaneously for 9 preoperative and 2 postoperative days. Placebo consisted of normal saline 0.9% placed in an identical syringe as the actual drug.
Also all patients recieved oral iron supplementation (200mg/day) for 9 preoperative and 2 postoperative days
Control group
Placebo

Outcomes
Primary outcome [1] 259230 0
Assesment of cytokines cascade expression with plasma and drainage fluid cytokine assays following the immunomodulation of Recombinant Human Erythropoietin
Timepoint [1] 259230 0
measured once between 6 am-7am hours on postoperative days 1, 3 and 5
Secondary outcome [1] 265635 0
not applicable
Timepoint [1] 265635 0
not applicable

Eligibility
Key inclusion criteria
The inclusion criterion was defined as an established preoperative diagnosis of breast cancer stage II or III.
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) hemoglobin concentration>13gr/dl at presentation, (2) previous history of malignancy, (3) history of thromboembolic events, (4) history of seizures, (5) hypertension, (6) known allergy to Recombinant Human Erythropoietin , (7) patients with hepatic, renal, metabolic or endocrine disease, (8) patients receiving medications known to interfere with wound healing, (9) neoadjuvant chemotherapy, (11) recent major surgical procedure or recent history of transfusion and (12) patient’s denial to informed consent.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
By means of a computational random number generator
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 2922 0
Greece
State/province [1] 2922 0
Ioannina

Funding & Sponsors
Funding source category [1] 257673 0
Hospital
Name [1] 257673 0
University Hospital of Ioannina
Address [1] 257673 0
Panepistimiou Ave, 45500, Ioannina
Country [1] 257673 0
Greece
Primary sponsor type
Hospital
Name
University Hospital of Ioannina
Address
Panepistimiou Ave, 45500, Ioannina
Country
Greece
Secondary sponsor category [1] 256888 0
None
Name [1] 256888 0
Address [1] 256888 0
Country [1] 256888 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259699 0
Ethics Committee of the University Hospital of Ioannina
Ethics committee address [1] 259699 0
Panepistimiou Ave, 45500 Ioannina
Ethics committee country [1] 259699 0
Greece
Date submitted for ethics approval [1] 259699 0
Approval date [1] 259699 0
Ethics approval number [1] 259699 0
250/10/7/2000

Summary
Brief summary
It is known that erythropoetin has been used in clinical practice to minimize blood transfusions in the surgical patients. The aim of this study was to evaluate the impact of erythropoetin in the immune system of breast cancer patients stage II/III in the context of the pleotropic properties of the drug that have been recently discovered. Our hypothesis was that by ameliorating the immune response, the drug may have some effect on tumor recurrence.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31657 0
Address 31657 0
Country 31657 0
Phone 31657 0
Fax 31657 0
Email 31657 0
Contact person for public queries
Name 14904 0
Evangelos Lolis
Address 14904 0
19, Gorgopotamou St
Marousi
15123
Athens
Country 14904 0
Greece
Phone 14904 0
00306944968481
Fax 14904 0
00302106775153
Email 14904 0
vaglolis@otenet.gr
Contact person for scientific queries
Name 5832 0
Evangelos Lolis
Address 5832 0
19, Gorgopotamou St
Marousi
15123
Athens
Country 5832 0
Greece
Phone 5832 0
00306944968481
Fax 5832 0
00302106775153
Email 5832 0
vaglolis@otenet.gr

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary