This exploratory, non-randomized clinical study aims to evaluate the potential impact of a diet enriched with fruits and chaya (Cnidoscolus aconitifolius) infusion on genomic instability and selected biochemical parameters in women with breast cancer undergoing neoadjuvant chemotherapy (NAC). Participants are assigned to either a control group receiving a conventional diet or an experimental group receiving the modified diet. Blood samples are collected at three time points during chemotherapy: prior to the first session, after the second cycle, and after the third cycle. The study involves the analysis of genomic instability using the comet assay, along with standard hematological and biochemical testing. The study was reviewed and approved by the Research Ethics Committee of the Graduate and Research Unit of the Faculty of Medicine at the Universidad Autónoma de Yucatán. It is being conducted between August 2022 and September 2024.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
13
Increased fruit consumption and daily intake of chaya infusion (prepared from Cnidoscolus chayamansa leaves),
Usual dietary habits, with no specific modifications
Universidad Anahuac Mayab
Mérida, Yucatán, Mexico
Genomic instability index (Comet assay)
Measurement of DNA damage in peripheral blood leukocytes using the Comet assay, reported as tail length and tail moment
Time frame: Baseline (prior to first NAC cycle), at the end of Cycle 2 (approximately Day 42), and at the end of Cycle 3 (approximately Day 63); each NAC cycle is 21 days in duration.
Serum creatinine levels
To assess kidney function during NAC under different dietary conditions.
Time frame: Baseline (prior to first NAC cycle), at the end of Cycle 2 (approximately Day 42), and at the end of Cycle 3 (approximately Day 63); each NAC cycle is 21 days in duration.
Serum aspartate aminotransferase levels
To evaluate hepatic enzyme fluctuations associated with diet and chemotherapy
Time frame: Baseline (prior to first NAC cycle), at the end of Cycle 2 (approximately Day 42), and at the end of Cycle 3 (approximately Day 63); each NAC cycle is 21 days in duration.
Blood glucose levels
To evaluate glycemia fluctuations associated with diet and chemotherapy
Time frame: Baseline (prior to first NAC cycle), at the end of Cycle 2 (approximately Day 42), and at the end of Cycle 3 (approximately Day 63); each NAC cycle is 21 days in duration.
Hemoglobin
To assess hematologic stability during the intervention period.
Time frame: Baseline (prior to first NAC cycle), at the end of Cycle 2 (approximately Day 42), and at the end of Cycle 3 (approximately Day 63); each NAC cycle is 21 days in duration.
Serum alanine aminotransferase levels
To evaluate hepatic enzyme fluctuations associated with diet and chemotherapy
Time frame: Baseline (prior to first NAC cycle), at the end of Cycle 2 (approximately Day 42), and at the end of Cycle 3 (approximately Day 63); each NAC cycle is 21 days in duration.
Platelet counts
To assess hemostasis stability during the intervention period.
Time frame: Baseline (prior to first NAC cycle), at the end of Cycle 2 (approximately Day 42), and at the end of Cycle 3 (approximately Day 63); each NAC cycle is 21 days in duration.
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