Relationship Between Alterations in the GI Microbiome and GI Inflammation on Symptom Burden in Women With Breast Cancer Receiving Chemotherapy

This study evaluates the relationship between alterations in the GI microbiome and GI inflammation on symptom burden in women with breast cancer receiving chemotherapy.

Study Overview

• Status: Recruiting
• Conditions: Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage III Breast Cancer AJCC v8
• Intervention / Treatment: Other: Non-Interventional Study

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.

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Recruiting
      • Mayo Clinic in Arizona
      • Principal Investigator: Komal P. Singh, Ph.D., R.N.
      • Contact: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu
      • Contact: Colleen Gallagher; Phone Number: 480-574-1346; Email: Gallagher.Colleen@mayo.edu
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Not yet recruiting
      • Mayo Clinic in Rochester
      • Principal Investigator: Kathryn J. Ruddy, M.D.
      • Contact: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 (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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Observational; Patients undergo stool and blood sample collection, complete questionnaires, and have their medical records reviewed on study.	Other: Non-Interventional Study; Non-interventional study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in GI microbiome profile	To examine longitudinal change in the GI microbiome, the coefficient of variation (CV) of alpha-diversity values will be calculated for stool samples. The CV represents the ratio of the standard deviation to the mean. A low CV indicates that an individual has relatively stable microbial diversity over time and a high CV indicates that an individual has higher microbial diversity over time.	Up to 1 month after chemotherapy treatment completion
Change in GI inflammation	GI Inflammation will be quantified through measures of fecal calprotectin to indicate low, medium and high concentrations of bowel inflammation.	Up to 1 month after chemotherapy treatment completion
Symptom burden - MSAS	Symptom burden will be measured with a modified version of the Memorial Symptom Assessment Scale (MSAS). The modified MSAS includes 41 symptom items, including 19 GI symptoms. Participants are asked to review the list of symptoms and indicate which had been present in the last week. For each symptom present, participants are asked to rate its duration, severity, and distress.	Up to 1 month after chemotherapy treatment completion
Symptom burden - MASCC-MAT	Symptom burden will be measured with the Multinational Association of Supportive Care in Cancer-Antiemesis Tool (MASCC-MAT). The MASCC-MAT assesses acute (i.e., within 24 hours post-chemotherapy) and delayed (i.e., after 24 hours and up to 7 days post-chemotherapy) occurrence of chemotherapy-induced nausea (CIN).	Up to 1 month after chemotherapy treatment completion
Symptom burden - LFS	Symptom burden will be measured with the Lee Fatigue Scale (LFS). The LFS consists of 18 items related to fatigue and energy. Scores range from 0-180 with higher scores indicating higher levels of fatigue.	Up to 1 month after chemotherapy treatment completion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Associations between microbial composition functional profiles and symptom severity	In patients who report symptom severity in neuropsychological and GI symptoms for at least three timepoints, stool samples will be tested to find distinct diversity and abundance changes between timepoints that are associated with symptom occurrence.	Up to 1 month after chemotherapy treatment completion
Change in metabolite abundance	In patients who do and do not report neuropsychological and GI symptom occurrence for at least three timepoints, stool samples and blood samples will be evaluated using liquid chromatography-tandem mass spectrometry (LC-MS/MS) to evaluate for change in metabolite abundance and associations between bacterial composition and metabolic profiles.	Up to 1 month after chemotherapy treatment completion

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Komal P. Singh, Ph.D., R.N., Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2024
• Primary Completion (Estimated): March 30, 2026
• Study Completion (Estimated): March 30, 2026

Study Registration Dates

• First Submitted: January 25, 2024
• First Submitted That Met QC Criteria: January 25, 2024
• First Posted (Actual): February 2, 2024

Study Record Updates

• Last Update Posted (Actual): March 27, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Inflammation
• Other Study ID Numbers: MC230407; NCI-2024-00288 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); 23-007468 (Other Identifier: Mayo Clinic Institutional Review Board)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No