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

Regina Elena Cancer Institute

Status: Enrolling

Conditions: Breast Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT06883201

RS1796/22

Details and patient eligibility

About

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

Full 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.

Enrollment: 78 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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.

Trial design

78 participants in 1 patient group

Patients with breast cancer who have received neoadjuvant chemotherapy or not

Description:

Perform a preoperative evaluation through laboratory screening (complete blood count with reticulocyte count, iron balance, vitamin B12 and folate) and prescribe, in case of documented deficiency anemia, a therapy with hematinics. The therapy of choice in most cases of iron deficiency is parenteral ferric carboxymaltose