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Impact of Supplementation With Synbiotics and Prebiotics on Cognitive Decline Associated With Neoadjuvant Chemotherapy in First-line Patients With Breast Cancer

NCT07465497 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-03-12

No results posted yet for this study

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Synbiotics Blend

Lactobacillus and inulin

DIETARY_SUPPLEMENT

Synbiotics + Vitamin D

Lactobacillus, inulin and colecalciferol.

DIETARY_SUPPLEMENT

Prebiotic

Agave Inulin

Sponsors & Collaborators

  • Instituto Tecnológico y de Estudios Superiores de Occidente

    collaborator OTHER

  • Instituto Oncológico Nacional

    collaborator UNKNOWN

  • University of Guadalajara

    collaborator OTHER

  • Instituto Jalisciense de Cancerologia

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-27
Primary Completion
2026-12-31
Completion
2027-02-28

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07465497 on ClinicalTrials.gov