Improving blood management for breast cancer patients undergoing surgery
Application of Patient Blood Management in the Oncology Patient Affected by Breast Cancer
This study tests whether giving iron treatment before surgery can help breast cancer patients with low hemoglobin levels need fewer blood transfusions during their operations.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 78 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Regina Elena Cancer Institute Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Rome) |
| Trial ID | NCT06883201 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of preoperative anemia treatment in breast cancer patients to reduce the need for blood transfusions during surgery. It focuses on patients with hemoglobin levels of 11 g/dL or lower, who may have undergone neoadjuvant chemotherapy. The approach involves optimizing hematopoiesis through intravenous iron treatment, aiming to minimize transfusion-related risks and improve surgical outcomes. The study is observational and assesses transfusion rates in a clinical setting.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with histologically confirmed breast cancer and low hemoglobin levels, who are scheduled for breast surgery.
Not a fit: Patients with known allergies to ferric carboxymaltose, high ferritin levels, or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the need for blood transfusions in breast cancer patients, leading to better surgical outcomes and fewer transfusion-related complications.
How similar studies have performed: Other studies have shown that preoperative anemia management can effectively reduce transfusion rates, indicating a promising approach in this context.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Rome
- "Regina Elena" National Cancer Institute — Rome, Italy (Recruiting)
Study contacts
- Study coordinator: Giuseppina A. Natale, Doctor
- Email: giuseppina.natale@ifo.it
- Phone: 06-52662984
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.