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

NCT06238986 | Terminated

• 3 other identifiers: MC230407NCI-2024-0028823-007468
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage III Breast Cancer AJCC v8

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• Associations between microbial composition functional profiles and symptom severity

  Up to 1 month after chemotherapy treatment completion

• Change in metabolite abundance

  Up to 1 month after chemotherapy treatment completion

Study Arms (1)

Observational

Patients undergo stool and blood sample collection, complete questionnaires, and have their medical records reviewed on study.

Other: Non-Interventional Study

Interventions

Non-Interventional Study OTHER

Non-interventional study

Observational

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (2)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Study Officials

• Komal P. Singh, PhD, RN

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2024
• First Posted: February 2, 2024
• Study Start: March 22, 2024
• Primary Completion: November 18, 2024
• Study Completion: November 18, 2024
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)