Breast CancerNCT07015294
Effect of a Fruit- and Chaya-Based Diet on Genomic Instability and Biochemical Markers in Women With Breast Cancer Receiving Chemotherapy
A study testing Fruits and chaya infusion and Conventional diet in people with Breast Cancer, run by Anahuac Mayab University at 1 site in Mexico.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 65 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Fruits and chaya infusion and Conventional diet
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteMexico
- Study dates
- 1 Aug 2022to 1 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Breast Cancer
- Being tested
- Fruits and chaya infusion, Conventional diet
- Keywords
- Breast cancer, Cnidoscolus chayamans, Genomic instability
- Medical subject headings
- Breast Neoplasms, Genomic Instability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fruits and chaya infusionDietary supplement
Increased fruit consumption and daily intake of chaya infusion (prepared from Cnidoscolus chayamansa leaves),
Conventional dietDietary supplement
Usual dietary habits, with no specific modifications
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: Fruits and chaya infusion |
| Conventional diet | Active comparator | Participants continued their usual dietary habits, with no specific modifications, throughout the course of neoadjuvant chemotherapy Receives: Dietary Supplement: Conventional diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genomic instability index (Comet assay)
Measurement of DNA damage in peripheral blood leukocytes using the Comet assay, reported as tail length and tail moment
Measured: 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 (6)
Serum creatinine levels
To assess kidney function during NAC under different dietary conditions.
Measured: 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
To evaluate hepatic enzyme fluctuations associated with diet and chemotherapy
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start1 Aug 2022
- Primary completion1 Jun 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anahuac Mayab University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elda Leonor Pacheco Pantoja, Anahuac Mayab University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07015294
- Sponsor's protocol ID
- 092024
- Status last verified
- May 2025
- First submitted
- 26 May 2025
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07015294
- Acronym / sponsor ID
- 092024
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Cnidoscolus chayamans, Genomic instability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Anahuac Mayab UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 11 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diet rich in fruits and chaya infusion | Experimental | Dietary Supplement: Fruits and chaya infusionParticipants 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 | Dietary Supplement: Conventional dietParticipants continued their usual dietary habits, with no specific modifications, throughout the course of neoadjuvant chemotherapy |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fruits and chaya infusionIncreased fruit consumption and daily intake of chaya infusion (prepared from Cnidoscolus chayamansa leaves), | Dietary supplement | Diet rich in fruits and chaya infusion |
| Conventional dietUsual dietary habits, with no specific modifications | Dietary supplement | Conventional diet |
Primary outcome
Genomic instability index (Comet assay)
Time frame: 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
6 secondary outcomes
Serum creatinine levels
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fruits and chaya infusion and Conventional diet in people with Breast Cancer, run by Anahuac Mayab University at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genomic instability index (Comet assay) (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2025.