Malignant Neoplasm: Breast, Unspecified Malignant neoplasm of nipple and areola
Conditions
Interventions
This is a randomized parallel and placebo-controlled clinical trial with two arms, with random allocation in a one-to-one ratio performed by an electronic system on the Research Electronic Data Captur
Sponsors
Liga Norte Riograndense Contra o Câncer
Liga Norte Riograndense Contra o Câncer
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Women aged eighteen years or older; confirmed histological diagnosis of breast cancer stages one to three according to the American Joint Committee on Cancer eighth edition; planning for neoadjuvant chemotherapy with the regimen consisting of doxorubicin and cyclophosphamide followed by paclitaxel for human epidermal growth factor receptor two negative profile; Eastern Cooperative Oncology Group performance status between zero and one; adequate renal hepatic and hematological function for receiving standard chemotherapy treatment
Exclusion criteria
Exclusion criteria: Patients with a history of prior chemotherapy for the current breast cancer diagnosis; chronic use of immunosuppressive drugs or corticosteroids; prior use of leukocyte colony stimulating factors; presence of active infection or uncontrolled human immunodeficiency virus diagnosis; history of known allergy to the supplement components; planning for a dose dense chemotherapy regimen; pregnant or lactating women; current use of prebiotics probiotics synbiotics or herbal supplements; prior diagnosis of autoimmune diseases or inflammatory bowel diseases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It’s expected to observe the proportion of patients with chemotherapy delay or definitive discontinuation through the monitoring of the oncological treatment schedule where percentages of participants presenting a delay equal to or greater than seven days in any cycle or definitive treatment suspension due to the occurrence of grade three or higher hematological toxicity according to the common terminology criteria for adverse events will be analyzed | — |
Secondary
| Measure | Time frame |
|---|---|
| It’s expected to find the occurrence of complications and treatment tolerability through laboratory tests clinical evaluations and electronic patient medical records where the incidence of febrile neutropenia infections hospitalizations severe neutropenia and lymphopenia rates relative dose intensity received and quality of life scores will be analyzed | — |
Countries
BR
Contacts
Public ContactLiga Norte Riograndese Contra o Câncer
Liga Norte Riograndense Contra o Câncer
Outcome results
None listed