Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Instituto Tecnológico y de Estudios Superiores de Occidente | OTHER |
| Instituto Oncológico Nacional | UNKNOWN |
| University of Guadalajara | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Synbiotic | Active Comparator | The intervention will last for a total of 4 months, coinciding with the chemotherapy treatment period. Each participant will take one capsule daily. Capsule: Lactobacillus acidophilus (LA3) Lactobacillus delbrueckii subsp. bulgaricus (SP 96) Lactobacillus casei (BGP 93) Lactobacillus plantarum (BG 112) Lactobacillus sporogenes, Lactobacillus rhamnosus and Agave Inulin) |
|
| Synbiotic with vitamin D3 | Active Comparator | The intervention will last for a total of 4 months, coinciding with the chemotherapy treatment period. Each participant will take one capsule daily. Capsule: Inulin, Lactobacillus rhamnosus, Lactobacillus plantarum, D3 Vitamin/Colecalciferol, Lactobacillus bulgaricus, Lactobacillus paracasei, Lactobacillus lactis) |
|
| Prebiotic | Active Comparator | The intervention will last for a total of 4 months, coinciding with the chemotherapy treatment period. Each participant will take one capsule daily. Capsule: Agave inulin. |
|
| No synbiotic/prebiotic | No Intervention | Participants in this arm won't have an intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Synbiotics Blend | Dietary Supplement | Lactobacillus and inulin |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Neuropsychological battery | Cognitive assessments using the CERAD neuropsychological battery. | Before the first cicle of chemotherapy and intervention, and after the four months of cancer treatment and intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| C-reactive Protein | Serum C-reactive Protein | Before the first cicle of chemotherapy and intervention, and after the four months of cancer treatment and intervention. |
| Calprotectin | Calprotectine in stool sample |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Oncológico Nacional | Zapopan | Jalisco | 44660 | Mexico |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
randomized, double blinded.
| Synbiotics + Vitamin D |
| Dietary Supplement |
Lactobacillus, inulin and colecalciferol. |
|
| Prebiotic | Dietary Supplement | Agave Inulin |
|
| Before the first cicle of chemotherapy and intervention, and after the four months of cancer treatment and intervention. |
| ID | Term |
|---|---|
| D000084202 | Chemotherapy-Related Cognitive Impairment |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
| D060825 | Cognitive Dysfunction |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D058616 | Synbiotics |
| D014807 | Vitamin D |
| D056692 | Prebiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019936 | Probiotics |
| D019602 | Food and Beverages |
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004043 | Dietary Fiber |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D011135 | Polysaccharides, Bacterial |
| D011134 | Polysaccharides |
Not provided
Not provided