Skip to main content
OpenTrials
Completed

NCT Number: NCT07015294

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

20 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Anahuac Mayab

Mérida, Yucatán, 97308, Mexico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fruits and chaya infusion

Dietary Supplement

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

Conventional diet

Dietary Supplement

Usual dietary habits, with no specific modifications

Primary outcomes

  1. Genomic instability index (Comet assay)

    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.

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

Secondary outcomes

  1. Serum creatinine levels

    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.

    To assess kidney function during NAC under different dietary conditions.

  2. Serum aspartate aminotransferase levels

    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.

    To evaluate hepatic enzyme fluctuations associated with diet and chemotherapy

  3. Blood glucose levels

    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.

    To evaluate glycemia fluctuations associated with diet and chemotherapy

  4. Hemoglobin

    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.

    To assess hematologic stability during the intervention period.

  5. Serum alanine aminotransferase levels

    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.

    To evaluate hepatic enzyme fluctuations associated with diet and chemotherapy

  6. Platelet counts

    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.

    To assess hemostasis stability during the intervention period.

Sponsors and collaborators

Lead sponsor

Anahuac Mayab University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jun 11, 2025
Registry last updated
Jun 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.