Can a gut antibiotic ease Chemo's stomach woes?
NCT ID NCT04249622
First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This study tested the antibiotic rifaximin (Xifaxan) to see if it could reduce stomach issues like bloating, pain, and diarrhea in people with early-stage HER2-positive breast cancer receiving pertuzumab-based chemotherapy. The trial planned to enroll 20 patients but was terminated early. The goal was to help patients complete their cancer treatment without delays or dose reductions due to side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- rifaximin (Xifaxan)
- What this could lead to
- If it works, this could offer a way to manage severe stomach side effects from breast cancer treatment, helping patients stay on their chemotherapy schedule.
- What could go wrong
- This was a small, early-phase trial that was terminated before completion, so results are limited. It is not a treatment for cancer itself, only for side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
20 people
The number who actually took part.
- Started
-
Sep 2020
- Finished
-
Dec 2022
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * PRE-REGISTRATION INCLUSION CRITERIA * Age \>= 18 years * Histological confirmation of HER2 positive breast cancer stage I-III per American Joint Committee on Cancer (AJCC) staging 8th edition * Provide written informed consent * Breast cancer patients who will be receiving pertuzumab-based chemotherapy with either TCHP (docetaxel, carboplatin, trastuzumab, and pertuzumab) or docetaxel/paclitaxel, trastuzumab, and pertuzumab * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2 * Hemoglobin \>= 10.0 g/dL (obtained =\< 30 days prior to pre-registration) * Absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L (obtained =\< 30 days prior to pre-registration) * Platelet count \>= 100 x 10\^9/L (obtained =\< 30 days prior to pre-registration) * Total bilirubin =\< 1.5 x ULN (institutional upper limit of normal) (obtained =\< 30 days prior to pre-registration) * Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 x ULN (obtained =\< 30 days prior to pre-registration) * Serum or plasma creatinine =\< 1.5 x ULN (obtained =\< 30 days prior to pre-registration) * Calculated creatinine clearance \>= 45 ml/min using the Cockcroft-Gault formula (obtained =\< 30 days prior to pre-registration) * Negative serum pregnancy test done =\< 30 days prior to pre-registration, for person of childbearing potential only * Willingness to return to enrolling institution for follow-up (during the active monitoring phase of the study) * Willingness to provide mandatory stool specimen for correlative research * Ability to complete questionnaire(s) by themselves or with assistance * REGISTRATION INCLUSION CRITERIA * Received pertuzumab based regimens in the adjuvant or neoadjuvant setting * Hemoglobin \>= 8.0 g/dL (obtained =\< 14 days prior to registration) * Absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L (obtained =\< 14 days prior to registration) * Platelet count \>= 100 x 10\^9/L (obtained =\< 14 days prior to registration) * Total bilirubin =\< 1.5 x ULN (institutional upper limit of normal) (obtained =\< 14 days prior to registration) * AST (SGOT)/ALT (SGPT) =\< 2.5 x ULN (obtained =\< 14 days prior to registration) * Serum or plasma creatinine =\< 1.5 x ULN (obtained =\< 14 days prior to registration) * Calculated creatinine clearance \>= 45 ml/min using the Cockcroft-Gault formula (obtained =\< 14 days prior to registration) Exclusion Criteria: * PRE-REGISTRATION EXCLUSION CRITERIA * History of myocardial infarction =\< 6 months prior to pre-registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias * Failure to recover from acute, reversible effects of prior therapy regardless of interval since last treatment * EXCEPTION: Grade 1 peripheral (sensory) neuropathy that has been stable for at least 3 months since completion of prior treatment * Uncontrolled intercurrent non-cardiac illness including, but not limited to: * Ongoing or active infection * Psychiatric illness/social situations * Dyspnea at rest due to complications of advanced malignancy or other disease that requires continuous oxygen therapy * Any other conditions that would limit compliance with study requirements * Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy * NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial * Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm (adjust to protocol if applicable) * Any of the following because this study involves an agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown * Pregnant women * Nursing women * Women of childbearing potential who are unwilling to employ adequate contraception * Current colostomy or ileostomy * History of inflammatory bowel disease * History of irritable bowel syndrome * History of arteriovenous malformations * History of gastrointestinal bleeds * Previous surgical resection of the small bowel or colon * Previous allergy to rifaximin or its derivatives
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980, United States
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