Clinical trial · Interventional
Effect of a Fruit- and Chaya-Based Diet on Genomic Instability and Biochemical Markers in Women With Breast Cancer Receiving Chemotherapy
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional diet | Dietary Supplement | — | UNRESOLVED |
| Fruits and chaya infusion | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Diet rich in fruits and chaya infusion
- description
- 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
- interventionNames
- Dietary Supplement: Fruits and chaya infusion
- type
- ACTIVE_COMPARATOR
- label
- Conventional diet
- description
- Participants continued their usual dietary habits, with no specific modifications, throughout the course of neoadjuvant chemotherapy
- interventionNames
- Dietary Supplement: Conventional diet
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available