Bladder Cancer, Bladder Carcinoma, Genitourinary System Carcinoma, Malignant Testicular Neoplasm, Melanoma, Prostate Cancer, Prostate Carcinoma, Sarcoma, Testicular Cancer
Conditions
Brief summary
The objective of this pilot cohort study is to investigate associations between CIN and changes in gut microbiome composition profiles.
Detailed description
The long-term goal of this study is to alleviate the occurrence of CIN and to improve chemotherapy treatment outcomes. The identification of associations between CIN and chemotherapy-induced changes in gut microbiome composition profiles will increase our understanding of these mechanisms that underlie CIN. An increased understanding of the underlying mechanisms will provide targets for the development of novel interventions to help alleviate CIN.
Interventions
OTHERBlood and Tissue
Patients will collect stool for microbiome analysis at baseline (i.e., 3 +2 days prior to chemotherapy) and again 5-7 days following initiation of chemotherapy. Blood samples will be collected prior to their first chemotherapy treatment, and in the second week after chemotherapy.
Sponsors
Mayo Clinic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* at least 20 years of age * last chemotherapy more than 3 years ago * scheduled to receive either moderate to highly emetogenic chemotherapy with or without targeted therapies including immunotherapies) or immunotherapies/targeted therapies alone that can lead to toxicity symptoms for example, nausea and fatigue. * Patients receiving chemotherapy and/or immunotherapy treatment at a Mayo Clinic infusion center or an infusion center outside of Mayo Clinic
Exclusion criteria
* concurrent radiation therapy * concurrent antibiotic treatment * concurrent oncolytic virus treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in patient recruitment | Baseline, 14 days | Evaluate the feasibility of patient recruitment by using descriptive statistics to determine number of patients approached and number of patients enrolled. |
| Change in patient retention | Baseline, 14 days | Evaluate the feasibility of patient retention by using descriptive statistics to determine number of patients who completed the questionnaires at both assessments. |
| Change in patient specimen collection | Baseline, 14 days | Evaluate the feasibility of patient specimen collection by using descriptive statistics to determine number patients who provided stool samples at both assessments. |
| Change of the gut microbiome | Up to 10 months | Evaluate for changes in alpha and beta diversity as well as composition of the gut microbiome pre- and post-chemotherapy in patients who do and do not report chemotherapy-induced nausea (CIN) after chemotherapy. Region V3-V5 of the 16s rRNA gene will be targeted for sequencing and submitted to trimmomatic for reads trimming and quality control. |
| Associations between microbial composition functional profiles | Up to 10 months | Examine associations between microbial composition functional profiles pre- and post-chemotherapy in patients who report chemotherapy-induced nausea (CIN) after chemotherapy. Change in relative abundance of genus associated with CIN occurrence will be used to predict the function of the genus. We will use PiCrust to perform functional profiling. |
| Evaluate for differentially abundant metabolites | Up to 10 months | Evaluate for differentially abundant metabolites associated with microbiome diversity in patients who do and do not report chemotherapy-induced nausea (CIN) after chemotherapy. Metabolomics profiling of stool samples pre- and post-chemotherapy using liquid chromatography-tandem mass spectrometry (LC-MS/MS). |
| Evaluate for perturbed metabolic pathways | Up to 10 months | Evaluate for perturbed metabolic pathways associated with microbiome diversity in patients who do and do not report chemotherapy-induced nausea (CIN) after chemotherapy. Metabolomics profiling will be performed on stool samples pre- and post-chemotherapy using liquid chromatography-tandem mass spectrometry (LC-MS/MS), as well as RNA-Seq analyses. |
Countries
United States
Outcome results
None listed