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

NCT07015294 | Completed DMC

• 1 other identifier: 092024
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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

Keywords

Breast cancer; Cnidoscolus chayamans; Genomic instability

Outcome Measures

Primary Outcomes (1)

• Genomic instability index (Comet assay)

  Measurement of DNA damage in peripheral blood leukocytes using the Comet assay, reported as tail length and tail moment

  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.

Secondary Outcomes (6)

• Serum creatinine levels

  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

  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

  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

  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

  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.

Study Arms (2)

Diet rich in fruits and chaya infusion

EXPERIMENTAL

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

Conventional diet

ACTIVE COMPARATOR

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

Dietary Supplement: Conventional diet

Interventions

Fruits and chaya infusion DIETARY_SUPPLEMENT

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

Diet rich in fruits and chaya infusion

Conventional diet DIETARY_SUPPLEMENT

Usual dietary habits, with no specific modifications

Conventional diet

Eligibility Criteria

• Age: 20 Years - 65 Years
• Gender Eligibility Details: Female participants
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Anahuac Mayab University: lead

Study Sites (1)

Universidad Anahuac Mayab

Mérida, Yucatán, 97308, Mexico

Location

MeSH Terms

Conditions

Breast Neoplasms; Genomic Instability

Interventions

Fruit

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Researcher

Study Record Dates

• First Submitted: May 26, 2025
• First Posted: June 11, 2025
• Study Start: August 1, 2022
• Primary Completion: June 1, 2024
• Study Completion: September 1, 2024
• Last Updated: June 11, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP

Locations

ME (1)