An interventional study of Fruits and chaya infusion and Conventional diet in Breast Cancer, sponsored by Anahuac Mayab University. Completed at 1 site in Mexico. Open to female participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-06-11.
Sponsored by Anahuac Mayab University · Not applicable, Interventional, and Supportive care
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 13 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Anahuac Mayab University is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Participants followed a diet emphasizing increased fruit consumption and daily intake of chaya infusion (prepared from Cnidoscolus chayamansa leaves), known for its potential antioxidant properties. The diet was maintained throughout neoadjuvant chemotherapy cycles
Dietary Supplement: Fruits and chaya infusion
Participants continued their usual dietary habits, with no specific modifications, throughout the course of neoadjuvant chemotherapy
Dietary Supplement: Conventional diet
Increased fruit consumption and daily intake of chaya infusion (prepared from Cnidoscolus chayamansa leaves),
Usual dietary habits, with no specific modifications
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.
Plan to share: Yes — De-identified individual participant data (IPD) that underlie the results reported in this study (including text, tables, figures, and appendices) will be made available to researchers upon reasonable request.
Supporting information: Sap
No publications or documents are linked to this record.
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Anahuac Mayab University