Breast cancer
Conditions
Interventions
Intervention: 50 women with HER2-negative breast cancer will undergo a four-day fasting-mimicking diet in the days preceding each chemotherapy cycle. Diet that mimics fasting is a vegetable-based diet
G07.203.650.240
Sponsors
Universidade Federal do Piauí
Universidade Federal do Piauí
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Female patients have a histologically confirmed diagnosis of HER2-negative, early stage II/III breast cancer (cT1cN + or =T2 any cN, cM0), and who have not yet started chemotherapy, adequate bone marrow; adequate liver function; adequate kidney function; normal heart function; age =18 years; BMI> 19 kg/m2; absence of diabetes mellitus; absence of allergy to MJD and signed consent form.
Exclusion criteria
Exclusion criteria: Previous 5-year malignancy, with the exception of a history of previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix; presence of other serious diseases, such as recent myocardial infarction, clinical signs of heart failure or clinically significant arrhythmias; BMI < 19 kg/m2; patient with severe weight loss; pregnancy or breastfeeding; significant food allergies that would make the subject unable to consume the food provided; medical or psychological condition that, in the investigator's opinion, would not allow the patient to complete the study or sign a meaningful informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected outcome 1: Reduction of grade I/II side effects (hematological, constitutional, gastrointestinal, dermatological and liver) of chemotherapy according to NCI CTCAE v4.03, from the observation of a reduction in the mean of the intervention group compared to the group control.;Expected outcome 2: improvement in the patients' quality of life; verifying through the instruments EORTC QLQ-C30 and Distress thermometer, from the comparison between the average result of the intervention and control groups.;Expected outcome 3: Tumor volume; assessed by ultrasound; considering complete clinical response (in the absence of measurable tumor), partial (reduction between 50 and 100%), stationary (reduction less than 50% or increase less than 25%) or progression (increase greater than 25% or the appearance of new injuries). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are not expected. | — |
Countries
Brazil
Contacts
Public ContactFrancisco Leonardo Leal
Outcome results
None listed