NCT07465497

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

Impact of Supplementation With Synbiotics and Prebiotics on Cognitive Decline Associated With Neoadjuvant Chemotherapy in First-line Patients With Breast Cancer at Stages IB to IIIC of Any Molecular Subtype.

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Instituto Jalisciense de Cancerologia · Other Government
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The primary aim of this research is to investigate the effects of supplementation with synbiotics and prebiotics on cognitive decline in patients diagnosed with breast cancer who are undergoing neoadjuvant chemotherapy. This study will utilize a double-blind, randomized design. Group 1: synbiotics (Lactobacillus acidophilus (LA3) Lactobacillus delbrueckii subsp. bulgaricus (SP 96) Lactobacillus casei (BGP 93) Lactobacillus plantarum (BG 112) Lactobacillus sporogenes, Lactobacillus rhamnosus and Agave Inulin) Group 2: synbiotics with D-vitamin (Inulin, Lactobacillus rhamnosus, Lactobacillus plantarum, D3 Vitamin/Colecalciferol, Lactobacillus bulgaricus, Lactobacillus paracasei, Lactobacillus lactis) Group 3: prebiotics (agave inulin) Group 4: None Duration: The intervention will last for a total of 4 months, coinciding with the chemotherapy treatment period. At the beginning of the study and at the end of the 4-month period, participants will undergo cognitive assessments using the CERAD neuropsychological battery. Additionally, blood and stool samples will be collected to analyze inflammation markers.

Conditions

• Chemobrain
• Breast Cancer
• Inflammatory Disease

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Synbiotics Blend	Lactobacillus and inulin
DIETARY_SUPPLEMENT	Synbiotics + Vitamin D	Lactobacillus, inulin and colecalciferol.
DIETARY_SUPPLEMENT	Prebiotic	Agave Inulin

Timeline

• Start date: 2026-02-27
• Primary completion: 2026-12-01
• Completion: 2027-02-01
• First posted: 2026-03-12
• Last updated: 2026-03-12

Locations

1 site across 1 country: Mexico