NCT07015294

Effect of a Fruit- and Chaya-Based Diet on Genomic Instability and Biochemical Markers in Women With Breast Cancer Receiving Chemotherapy

Effects of a Fruit- and Vegetable-Based Diet With Chaya Supplementation on Genomic Instability Indices and Biochemical Parameters in Breast Cancer Patients Undergoing Neoadjuvant Treatment

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Anahuac Mayab University · Academic / Other
• Sex: Female
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Fruits and chaya infusion	Increased fruit consumption and daily intake of chaya infusion (prepared from Cnidoscolus chayamansa leaves),
DIETARY_SUPPLEMENT	Conventional diet	Usual dietary habits, with no specific modifications

Timeline

• Start date: 2022-08-01
• Primary completion: 2024-06-01
• Completion: 2024-09-01
• First posted: 2025-06-11
• Last updated: 2025-06-11

Locations

1 site across 1 country: Mexico