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

Official title

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.

Overview

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.

Interventions

• Dietary supplement Synbiotics Blend
  Lactobacillus and inulin
• Dietary supplement Synbiotics + Vitamin D
  Lactobacillus, inulin and colecalciferol.
• Dietary supplement Prebiotic
  Agave Inulin

Primary outcome measures

• Neuropsychological battery [Time frame: Before the first cicle of chemotherapy and intervention, and after the four months of cancer treatment and intervention.]

Secondary outcome measures (2)

• C-reactive Protein [Time frame: Before the first cicle of chemotherapy and intervention, and after the four months of cancer treatment and intervention.]
• Calprotectin [Time frame: Before the first cicle of chemotherapy and intervention, and after the four months of cancer treatment and intervention.]

Eligibility criteria

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, Parkinson's disease, or other conditions that affect cognitive function will be excluded.
• Pregnant or Lactating Women: Pregnant or breastfeeding women will not be eligible to participate in the study.
• Allergies: Individuals with known allergies to any of the components of the synbiotics or prebiotics used in the study will be excluded.
• Non-compliance Risk: Participants who are deemed at risk of non-compliance with study procedures or follow-up will be excluded.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Supportive care

Study locations

Mexico · 1 center

• Instituto Oncológico Nacional — Zapopan

Identifiers

NCT: NCT07465497 · PRO-106-25

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗