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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Genomic instability index (Comet assay)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Genomic instability index (Comet assay)
时间窗: 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
次要结局
- 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.)
- Platelet counts(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.)
研究者
Elda Leonor Pacheco Pantoja
Senior Researcher
Anahuac Mayab University