Clinical trial NCT07015294: Effect of a Fruit- and Chaya-Based Diet on Genomic Instability and Biochemical Markers in Women With Breast Cancer Receiving Chemotherapy
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Breast cancer
Cnidoscolus chayamans
Genomic instability
Lead sponsor: Anahuac Mayab University
Sponsor class: OTHER
First posted: 2025-06-11
Enrollment: 13
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Genomic instability index (Comet assay)
timeFrame: 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:
measure: Serum creatinine levels
timeFrame: 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.
measure: Serum aspartate aminotransferase levels
timeFrame: 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.
measure: Blood glucose levels
timeFrame: 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.
measure: Hemoglobin
timeFrame: 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.
measure: Serum alanine aminotransferase levels
timeFrame: 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.
measure: Platelet counts
timeFrame: 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.
Other outcomes:
Locations:
city: Merida
country: Mexico
facility: Universidad Anahuac Mayab
state: Yucatan
Study officials:
References: