Breast Cancer
Conditions
Keywords
Breast cancer, Cnidoscolus chayamans, Genomic instability
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.
Interventions
DIETARY_SUPPLEMENTFruits and chaya infusion
Increased fruit consumption and daily intake of chaya infusion (prepared from Cnidoscolus chayamansa leaves),
DIETARY_SUPPLEMENTConventional diet
Usual dietary habits, with no specific modifications
Sponsors
Anahuac Mayab University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Genomic instability index (Comet assay) | 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
| Measure | Time frame | Description |
|---|---|---|
| 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. | To evaluate hepatic enzyme fluctuations associated with diet and chemotherapy |
| 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. | To evaluate glycemia fluctuations associated with diet and chemotherapy |
| 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. | To assess kidney function during NAC under different dietary conditions. |
| 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. | To evaluate hepatic enzyme fluctuations associated with diet and chemotherapy |
| 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. | To assess hemostasis stability during the intervention period. |
| 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. | To assess hematologic stability during the intervention period. |
Countries
Mexico
Outcome results
None listed