CompletedPhase 2ACTRN12610000813088

Effects of perioperative Recombinant Human Erythropoietin administration on proinflammatory cascade following breast cancer surgery.

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


Sponsor

University Hospital of Ioannina

Enrollment

22 participants

Start Date

Feb 28, 2000

Study Type

Interventional

Conditions

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.


Eligibility

Sex: FemalesMin Age: 18 Yearss

Inclusion Criteria1

  • The inclusion criterion was defined as an established preoperative diagnosis of breast cancer stage II or III.

Exclusion Criteria1

  • (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.

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Interventions

Study group: subcutaneous perioperative administration of Recombinant Human Erythropoietin (10000IU/day, subcutaneously) for 9 preoperative and 2 postoperative days Also all patients recieved oral ir

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


Locations(1)

Ioannina, Greece

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ACTRN12610000813088