Diet that mimics Fasting in patients with Breast Cancer treated by SUS: effects on reducing the effects caused, quality of life, progression, metastasis and tumor sensitizatio

Not Applicable

• Conditions: Breast cancer; oncogene protein HER2; antineoplastic agents; SH1.020.020.040.050

• Registration Number: RBR-3nvsj3z
• Lead Sponsor: niversidade Federal do Piauí

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-21
• Last Update Posted: 29 May 2023
• Study Completion: 2024-12-15

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Secondary outcomes are not expected.