Application of Patient Blood Management in the Oncology Patient Affected by Breast Cancer

Last updated: March 12, 2025
Sponsor: Regina Elena Cancer Institute
Overall Status: Active - Recruiting

Phase

N/A

Condition

Breast Cancer

Cancer

Treatment

N/A

Clinical Study ID

NCT06883201
RS1796/22
  • Ages > 18
  • Female

Study Summary

Evaluation of the percentage of transfusions in patients with breast cancer undergoing surgery after preventive treatment with haematinics.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • age > 18 years;

  • patients diagnosed with histologically confirmed breast cancer and whether or notthey have undergone neoadjuvant chemotherapy;

  • patients who are candidates for destructive and reconstructive breast surgery ornot;

  • Hb values less than or equal to 11 g/dL and/or transferrin saturation less than orequal to 20%;

  • written informed consent.

Exclusion

Exclusion Criteria:

  • patients with known allergies to ferric carboxymaltose or its excipients;

  • ferritin values greater than 500 ng/ml;

  • patients unable to sign consent and comply with procedures.

Study Design

Total Participants: 78
Study Start date:
January 31, 2023
Estimated Completion Date:
June 30, 2025

Study Description

Preoperative anemia treatment is fundamental in Patient Blood Management (PBM) programs, a multidisciplinary and multimodal strategy that improves clinical outcomes based on the patient's blood resource, promoting strategies to optimize hematopoiesis in candidates for elective surgery, in order to significantly reduce the use of blood products, addressing all modifiable transfusion risk factors before it is even necessary to consider the use of transfusion therapy itself. Treatment with intravenous iron reduces the transfusion risk and consequently the adverse events related to the transfusion itself.

Nothing is specified in this regard for cancer patients; very often these patients come to surgery presenting an anaemic state that often requires correction with red blood cell transfusion. The aim of this clinical study is to prevent the number of perioperative transfusions in patients with breast cancer who have undergone or not undergone neoadjuvant chemotherapy and with Hb values lower than or equal to 11 g/dl, who are candidates for destructive and/or reconstructive surgery.

Connect with a study center

  • "Regina Elena" National Cancer Institute

    Rome, 00144
    Italy

    Active - Recruiting

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