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

Recruiting

• Conditions: Breast Cancer

• Registration Number: NCT06883201
• Lead Sponsor: Regina Elena Cancer Institute

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.

Study Timeline

• Study Start: 2023-01-31
• Status Verified: 2025-03
• Study First Submitted: 2025-03-12
• Study First Submitted QC: 2025-03-12
• Last Update Submitted: 2025-03-12
• Study First Posted: 2025-03-19
• Last Update Posted: 2025-03-19
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 78

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

"Regina Elena" National Cancer Institute; 🇮🇹 Rome, Italy