Breast Neoplasms
Conditions
Interventions
The study is a randomized, two-arm, placebo-controlled, and triple-blind clinical trial for the dietary intervention. Sixty-four sedentary breast cancer survivors, between 6 months and 5 years after c
G11.427.410.698.277
G07.203.300.456
Sponsors
Universidade Federal de Santa Catarina - UFSC
Prefeitura Municipal de Imbituba
Eligibility
Sex/Gender
Female
Age
30 Years to 75 Years
Inclusion criteria
Inclusion criteria: Sample inclusion will follow the criteria below: women with a diagnosis of primary breast cancer confirmed by histopathological evidence of malignancy; staging classified as 0 to IIIb at the time of diagnosis; completion of chemo- and/or radiotherapy treatment at least 6 months prior to the start of the study and less than 5 years; age between 30 and 75 years; sedentary women (25 kg/m²; medical clearance to engage in physical activity issued by an oncologist or cardiologist; no regular alcohol consumption (no more than one drink/week — i.e., one can of beer, 150 mL of wine, or 45 mL of distilled beverage); no use of dietary supplements within the previous 3 months and no current clinical conditions such as infections or visible/known inflammatory processes; absence of cardiovascular, endocrine, gastrointestinal, renal, or hepatic diseases.
Exclusion criteria
Exclusion criteria: The non-inclusion criteria will comprise the following factors: history of other types of cancer; presence of metastasis or recurrence; pregnancy or lactation; BMI <25 kg/m²; current smoking.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A reduction of 1.3 kg in total body fat is expected, which is one of the risk factors for breast cancer recurrence. Body composition will be measured using dual-energy X-ray absorptiometry (DXA), allowing the assessment of fat mass, lean mass, and fat distribution. | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvements are expected in blood metabolic markers, including fasting glucose (mg/dL), glycated hemoglobin (mmol/mol), triglycerides (mg/dL), total cholesterol and its fractions (mg/dL), insulin (µU/mL), adiponectin (µg/mL), and leptin (ng/mL). These substances are involved in energy metabolism and inflammatory regulation, and alterations in their levels may influence the risk of breast cancer recurrence and progression, as metabolic imbalances promote a tumor-friendly environment. Fasting serum glucose levels, cholesterol and fractions, and triglycerides will be determined using the colorimetric endpoint method based on the Trinder reaction. Glycated hemoglobin (HbA1c) levels will be quantified using the low-pressure ion-exchange chromatography method. Adiponectin and leptin concentrations will be analyzed by enzyme-linked immunosorbent assay (ELISA). Insulin quantification will be performed using a chemiluminescent enzyme immunoassay.;A reduction in blood inflammatory markers, including cytokines IL-6, IL-8, IL-10, TNF-a (ng/mL or pg/mL), and C-reactive protein (CRP) (pg/mL), is expected in breast cancer survivors, as chronic inflammation is associated with risk of tumor progression and recurrence. The concentrations of cytokines IL-6, IL-8, IL-10, and TNF-a will be analyzed using an enzyme-linked immunosorbent assay (ELISA). Serum hs-CRP levels will be assessed by immunonephelometry.;An improvement is expected in oxidative stress markers (total antioxidant capacity (TAC), reduced glutathione (GSH), and lipid hydroperoxides (LOOH) ) since redox balance is related to cellular protection and may influence the risk of breast cancer recurrence. The method for determining TAC is based on the ability of antioxidants to neutralize the stable radical cation ABTS (2,2’-azinobis-(3-ethylbenz-thiazoline-6-sulfonic diammonium salt)), a blue-green chromophore with maximum absorbance at 660 nm, compared to the antioxidant capacity of Trolox, a water-soluble analogue of vitami | — |
Countries
Brazil
Contacts
Public ContactPatricia Di Pietro
Universidade Federal de Santa Catarina - UFSC
Outcome results
None listed