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

Anahuac Mayab University

Status: Completed

Conditions: Breast Cancer

Treatments: Dietary Supplement: Fruits and chaya infusion; Dietary Supplement: Conventional diet

Study type: Interventional

Funder types: Other

Identifiers

NCT07015294

092024

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: Female

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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13 participants in 2 patient groups

Diet rich in fruits and chaya infusion

Experimental group

Description:

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

Treatment:

Dietary Supplement: Fruits and chaya infusion

Conventional diet

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Conventional diet