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

NCT ID: NCT07015294

Last Updated: 2025-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2024-09-01

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Diet rich in fruits and chaya infusion

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

Group Type: EXPERIMENTAL

Fruits and chaya infusion

Intervention Type: DIETARY_SUPPLEMENT

Increased fruit consumption and daily intake of chaya infusion (prepared from Cnidoscolus chayamansa leaves),

Conventional diet

Participants continued their usual dietary habits, with no specific modifications, throughout the course of neoadjuvant chemotherapy

Group Type: ACTIVE_COMPARATOR

Conventional diet

Intervention Type: DIETARY_SUPPLEMENT

Usual dietary habits, with no specific modifications

Interventions

Fruits and chaya infusion

Increased fruit consumption and daily intake of chaya infusion (prepared from Cnidoscolus chayamansa leaves),

Intervention Type: DIETARY_SUPPLEMENT

Conventional diet

Usual dietary habits, with no specific modifications

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Female participants aged 20-65 years
• Histologically confirmed breast cancer diagnosis
• Scheduled to undergo neoadjuvant chemotherapy
• Ability to consume chaya infusion and fruits as part of diet
• Provided informed consent

Exclusion Criteria

• Diabetes mellitus or other uncontrolled metabolic diseases
• Severe hepatic or renal insufficiency prior to NAC
• Allergy or intolerance to any component of the experimental diet
• Participation in other clinical trials during the study period

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Anahuac Mayab University

OTHER

Sponsor Role: lead

Responsible Party

Elda Leonor Pacheco Pantoja

Senior Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Universidad Anahuac Mayab

Mérida, Yucatán, Mexico

Countries

Mexico

Other Identifiers

092024

Identifier Type: -

Identifier Source: org_study_id