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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000813088

Enrollment

Registered

2010-09-29

Start date

2000-02-28

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

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 iron supplementation (200mg/day) for 9 preoperative and 2 postoperative days

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

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.

Outcome results