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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06883201

Enrollment

Registered

2025-03-19

Start date

2023-01-31

Completion date

2025-06-30

Last updated

2025-03-19

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

Conditions

Breast Cancer

Brief summary

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

Detailed 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Number of transfusions	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

Countries

Italy

Contacts

Primary ContactGiuseppina A. Natale, Doctor

giuseppina.natale@ifo.it06-52662984

Outcome results