Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Conventional diet | Active Comparator | Participants continued their usual dietary habits, with no specific modifications, throughout the course of neoadjuvant chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fruits and chaya infusion | Dietary Supplement | Increased fruit consumption and daily intake of chaya infusion (prepared from Cnidoscolus chayamansa leaves), |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Serum creatinine levels | To assess kidney function during NAC under different dietary conditions. | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Female participants
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad Anahuac Mayab | Mérida | Yucatán | 97308 | Mexico |
De-identified individual participant data (IPD) that underlie the results reported in this study (including text, tables, figures, and appendices) will be made available to researchers upon reasonable request.
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D042822 | Genomic Instability |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D005638 | Fruit |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Conventional diet | Dietary Supplement | Usual dietary habits, with no specific modifications |
|
To evaluate hepatic enzyme fluctuations associated with diet and chemotherapy |
| 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 | To evaluate glycemia fluctuations associated with diet and chemotherapy | 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 | To assess hematologic stability during the intervention period. | 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 | To evaluate hepatic enzyme fluctuations associated with diet and chemotherapy | 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 | To assess hemostasis stability during the intervention period. | 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. |
| D017437 |
| Skin and Connective Tissue Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |