Breast neoplasm, Antineoplastic Combined Chemotherapy Protocols
Conditions
Interventions
This is a randomized, block-design, parallel, open-label clinical trial. Intervention group: 10 to 30 patients will consume orange juice produced from Pera oranges (Citrus sinensis L. Osbeck), pasteur
Sponsors
Departamento de Clínica Média - Faculdade de Medicina de Botucatu
Departamento de Clínica Média - Faculdade de Medicina de Botucatu
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Women; over 18 years old; under follow-up at the Oncology service of the Hospital das Clínicas de Botucatu; diagnosed with any type of breast cancer; will receive treatment with doxorubicin in combination with cyclophosphamide.
Exclusion criteria
Exclusion criteria: Gastrointestinal tract disease prior to the cancer diagnosis; use of antibiotic therapy or medications that interfere with intestinal function (such as laxatives, intestinal motility inhibitors or stimulants, or pre/probiotics); constipation; diarrheia; vegetarians; vegans.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to identify changes in the intestinal microbiota induced by chemotherapy with doxorubicin and cyclophosphamide, as well as to assess how orange juice intake may influence these alterations. To achieve this, the bacterial communities will be characterized through genetic analysis using 16S rDNA sequencing, comparing stool samples before and after chemotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Assess the behavior of the intestinal permeability markers zonulin-1 and lipopolysaccharide using the Sandwich Enzyme-Linked ImmunoSorbent Assay method and the influence of orange juice intake on these markers;Behavior of systemic inflammation markers after chemotherapy and the influence of orange juice intake on these markers. The markers used for analysis will include fecal calprotectin, assessed using a commercial Enzyme-Linked ImmunoSorbent Assay kit, and short-chain fatty acids, evaluated by gas chromatography coupled with mass spectrometry. Laboratory test results available in the patients’ medical records will also be assessed;Assess the influence of orange juice intake on the occurrence, frequency, and severity of symptoms and side effects after chemotherapy. For this purpose, a questionnaire on the occurrence of chemotherapy-related symptoms will be administered | — |
Countries
Brazil
Contacts
Public ContactLara Carreira
Faculdade de Medicina de Botucatu - Universidade Estadual Paulista "Julio de Mesquita Filho"
Outcome results
None listed