To hear about similar clinical trials, please enter your email below
Trial Title:
Relationship Between Alterations in the GI Microbiome and GI Inflammation on Symptom Burden in Women with Breast Cancer Receiving Chemotherapy
NCT ID:
NCT06238986
Condition:
Anatomic Stage I Breast Cancer AJCC V8
Anatomic Stage II Breast Cancer AJCC V8
Anatomic Stage III Breast Cancer AJCC V8
Conditions: Official terms:
Breast Neoplasms
Inflammation
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Non-Interventional Study
Description:
Non-interventional study
Arm group label:
Observational
Summary:
This study evaluates the relationship between alterations in the GI microbiome and GI
inflammation on symptom burden in women with breast cancer receiving chemotherapy.
Detailed description:
PRIMARY OBJECTIVES:
I. To describe changes in GI inflammation and the GI microbiome profile in women with
breast cancer throughout chemotherapy.
II. To examine how GI inflammation and GI microbiome changes influence symptom experience
is used above in women with breast cancer receiving chemotherapy.
III. To examine associations between microbial composition functional profiles at T1 and
T2, T3 as well as T4 in patients who report symptom severity in neuropsychological and GI
symptoms at the last three timepoints.
IV. To evaluate for differentially abundant metabolites and perturbed metabolic pathways
associated with microbiome diversity in patients who do and do not report
neuropsychological and GI symptom occurrence at T2, T3 and T4.
OUTLINE: This is an observational study.
Patients undergo stool and blood sample collection, complete questionnaires, and have
their medical records reviewed on study.
Criteria for eligibility:
Study pop:
Women with newly diagnosed stage I-III breast cancer recruited from the outpatient breast
cancer clinic at University of Iowa Hospital and Clinics and at Mayo Clinic in Rochester
and Mayo Clinic in Arizona.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Female with a new diagnosis of breast cancer (stage I-III)
- Age 20 or older
- Able to read and write in English
- Chemotherapy naive and beginning the first cycle of moderately or highly emetogenic
chemotherapy (For example, Taxotere + cyclophosphamide treatment +/- trastuzumab).
Patients who have not received chemotherapy for five years or more are considered
chemotherapy naive
Exclusion Criteria:
- Metastatic disease
- Cognitive impairment, based on clinician assessment, that would prevent completing
measures
- Concurrent radiation therapy or radiation therapy within the last three months
- GI co-morbidities (i.e., irritable bowel syndrome, gastroesophageal reflux disease)
or bowel surgery within the last three months
- A stoma preventing stool collection from the large intestine (i.e., ileostomy)
Gender:
Female
Minimum age:
20 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Mayo Clinic in Arizona
Address:
City:
Scottsdale
Zip:
85259
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Contact backup:
Last name:
Colleen Gallagher
Phone:
480-574-1346
Email:
Gallagher.Colleen@mayo.edu
Contact backup:
Last name:
Komal P. Singh, PhD, RN
Facility:
Name:
Mayo Clinic in Rochester
Address:
City:
Rochester
Zip:
55905
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Contact backup:
Last name:
Kathryn J. Ruddy, MD
Start date:
March 22, 2024
Completion date:
March 30, 2026
Lead sponsor:
Agency:
Mayo Clinic
Agency class:
Other
Source:
Mayo Clinic
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06238986
https://www.mayo.edu/research/clinical-trials
