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

NCT06883201 | Recruiting

• 1 other identifier: RS1796/22
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Number of transfusions

  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

  18 months

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with breast cancer who have undergone or not undergone neoadjuvant chemotherapy and with Hb values lower than or equal to 11 g/dl, candidates for destructive and/or reconstructive surgery.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Regina Elena Cancer Institute: lead
• Campus Bio-Medico University: collaborator
• Umberto I Hospital, Frosinone Italy: collaborator

Study Sites (1)

"Regina Elena" National Cancer Institute

Rome, 00144, Italy

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Giuseppina A. Natale, Doctor

CONTACT

06-52662984; giuseppina.natale@ifo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2025
• First Posted: March 19, 2025
• Study Start: January 31, 2023
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: March 19, 2025

Record last verified: 2025-03

Locations

IT (1)