Clinical trial · Observational
Relationship Between Alterations in the GI Microbiome and GI Inflammation on Symptom Burden in Women With Breast Cancer Receiving Chemotherapy
NCT06238986CI-TRIAL-00091361terminatedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of funding
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anatomic Stage I Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage II Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage III Breast Cancer AJCC v8 | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Non-Interventional Study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Observational
- description
- Patients undergo stool and blood sample collection, complete questionnaires, and have their medical records reviewed on study.
- interventionNames
- Other: Non-Interventional Study
Primary outcomes (5)
- measure
- Change in GI microbiome profile
- timeFrame
- Up to 1 month after chemotherapy treatment completion
- description
- 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.
- measure
- Change in GI inflammation
- timeFrame
- Up to 1 month after chemotherapy treatment completion
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.