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

NCT ID: NCT06883201

Last Updated: 2025-03-19

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 78 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-31
• Study Completion Date: 2025-06-30

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.

Conditions

Breast Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with breast cancer who have received neoadjuvant chemotherapy or not

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

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Campus Bio-Medico University

OTHER

Sponsor Role: collaborator

Umberto I Hospital, Frosinone Italy

OTHER

Sponsor Role: collaborator

Regina Elena Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

"Regina Elena" National Cancer Institute

Rome, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Giuseppina A. Natale, Doctor

Role: CONTACT

giuseppina.natale@ifo.it

06-52662984 ext. +39

Other Identifiers

RS1796/22

Identifier Type: -

Identifier Source: org_study_id