Impact of Supplementation With Synbiotics and Prebiotics on Cognitive Decline Associated With Neo… (NCT07465497) | Clinical Trial Compass
By InvitationNot Applicable
Impact of Supplementation With Synbiotics and Prebiotics on Cognitive Decline Associated With Neoadjuvant Chemotherapy in First-line Patients With Breast Cancer
Mexico80 participantsStarted 2026-02-27
Plain-language summary
The goal of this research protocol is to evaluate whether supplementation with: synbiotics (probiotics with agave inulin), synbiotics with vitamid D or prebiotics (agave inulin) can reduce cognitive decline in patients with breast cancer undergoing neoadjuvant chemotherapy. It will also assess the safety of these supplements. The main questions it aims to answer are:
Does supplementation with synbiotics and prebiotics decrease cognitive decline in participants? What adverse effects do participants experience while taking these supplements? Are there significant changes in inflammation markers (calprotectin and C-reactive protein) before and after treatment?
Participants will:
Receive either synbiotics, prebiotics or none daily for 4 months. Undergo cognitive assessments using the CERAD neuropsychological battery at the beginning and end of the study.
Provide blood and stool samples for analysis of inflammation markers. Report any adverse effects experienced during the supplementation period.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age: Participants must be between 18 and 75 years old.
* Diagnosis: Must have a confirmed diagnosis of breast cancer at stages IB to IIIC.
* Treatment Status: Participants should be scheduled to receive neoadjuvant chemotherapy as part of their treatment plan.
* Cognitive Function: Must demonstrate baseline cognitive function as assessed by the CERAD neuropsychological battery, indicating no severe cognitive impairment.
* Informed Consent: Participants must provide written informed consent to participate in the study and comply with all study procedures.
* Health Status: Should not have any significant comorbidities that could interfere with the study outcomes, such as severe psychiatric disorders or neurological conditions.
* No Previous Probiotic Use: Must not have used probiotics or prebiotics in the month prior to the study
Exclusion Criteria:
* Severe Cognitive Impairment: Participants with significant cognitive impairment or dementia as assessed by the CERAD neuropsychological battery will be excluded.
* Severe Comorbidities: Participants with serious comorbid conditions, such as uncontrolled diabetes, severe cardiovascular diseases, or active infections, will be excluded.
* Psychiatric Disorders: Individuals with a history of severe psychiatric disorders that could affect cognitive function or compliance with the study protocol will be excluded.
* Neurological Conditions: Participants with neurological disorders such as multiple sclerosis, Park…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Neuropsychological battery
Timeframe: Before the first cicle of chemotherapy and intervention, and after the four months of cancer treatment and intervention.