Clinical trial · Observational
Effects of Chemotherapy on Intestinal Bacteria in Patients With Newly Diagnosed Breast Cancer
Changes in Intestinal Microbiota in Association With Chemotherapy Treatment
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This pilot research trial studies the effects of chemotherapy on intestinal bacteria/organisms (microbiota) in patients newly diagnosed with breast cancer. Change in intestinal microbiota may be associated with weight gain in patients treated with chemotherapy. Weight gain has been also associated with cancer recurrence. Examining the types and quantity of bacterial composition in the stool of breast cancer patients treated with chemotherapy may help determine whether body weight and composition are associated with changes in the intestinal microbiota and allow doctors to plan better treatment to prevent weight gain and possibly disease recurrence.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ductal Breast Carcinoma In Situ | Breast Ductal Carcinoma In Situ | ALIAS | 0.90 |
| Invasive Breast Carcinoma | Invasive Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Stage I Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIA Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIB Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIA Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cytology Specimen Collection Procedure | Other | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Group A (stool collection after adjuvant chemotherapy)
- description
- Patients undergo collection of stool samples at baseline (before surgery), at 1 week before initiation of adjuvant chemotherapy (after surgery), and at 1 and 4 months after completion of adjuvant chemotherapy.
- interventionNames
- Other: Cytology Specimen Collection Procedure
- Other: Laboratory Biomarker Analysis
- Other: Questionnaire Administration
- label
- Group B (stool collection after adjuvant chemotherapy)
- description
- Patients undergo collection of stool samples at baseline (after surgery), at 1 week before initiation of adjuvant chemotherapy, and at 1 and 4 months after completion of adjuvant chemotherapy.
- interventionNames
- Other: Cytology Specimen Collection Procedure
- Other: Laboratory Biomarker Analysis
- Other: Questionnaire Administration
- label
- Group C (stool collection after neoadjuvant chemotherapy)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Newly diagnosed ductal carcinoma in situ or invasive breast cancer (stage I, stage IIA, stage IIB, and stage IIIA breast cancer) * A treatment group including surgery followed by standard treatment of adjuvant chemotherapy such as doxorubicin and cyclophosphamide followed by paclitaxel, docetaxel and cyclophosphamide, or a treatment group including neoadjuvant chemotherapy followed by surgery at the Norris or LAC+USC Medical Center * Women of child-bearing potential agree to pregnancy test to confirm she is not pregnant * Provide informed consent Exclusion Criteria: * Metastatic, recurrent, synchronous or metachronous breast cancer * History of other cancers (other than non-melanoma skin cancer) * History of autoimmune celiac or inflammatory bowel disease * Past bariatric surgery * Current or recent pregnancy or nursing (within past 12 months) * Past treatment with chemotherapy * Recent use (within past month) of more than 3 days of antibiotics use * Current use of probiotic supplements
References
Publications (0)
Data not yet available