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Recruiting

NCT Number: NCT06883201

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

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

"Regina Elena" National Cancer Institute

Rome, 00144, Italy

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age > 18 years;
  • patients diagnosed with histologically confirmed breast cancer and whether or not they have undergone neoadjuvant chemotherapy;
  • patients who are candidates for destructive and reconstructive breast surgery or not;
  • Hb values less than or equal to 11 g/dL and/or transferrin saturation less than or equal to 20%;
  • written informed consent.

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.

Treatment and study plan

Primary outcomes

  1. Number of transfusions

    Time frame: 18 months

    To evaluate the percentage, in number of transfusions in patients affected by breast cancer, candidates for destructive and/or reconstructive breast surgery after preventive treatment with haematinics

Study contacts

Contact information is provided by the study sponsor or research team.

Giuseppina A. Natale, Doctor

CONTACT

[email protected]

06-52662984 ext. +39

Sponsors and collaborators

Lead sponsor

Regina Elena Cancer Institute

Other

Collaborators

  • Campus Bio-Medico University
  • Umberto I Hospital, Frosinone Italy

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 19, 2025
Registry last updated
Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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