Probiotic Supplementation During Cytotoxic Chemotherapy for Solid Tumor Malignancies
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMasonic Cancer Center, University of Minnesota
About this trial
This is a pilot single-blind placebo-controlled randomized trial to establish experimental feasibility. We plan on enrolling a pilot cohort of 40 patients, with up to 5 patients in treatment phase 0 and the remaining in treatment phase I. During Phase I, the remaining participants will be assigned to either treatment or control group using dynamic block randomization balancing on sex, age group, and disease histology.
Eligibility criteria
Qualifiers
Adults ≥18 years old
Diagnosis of stage III colon cancer
Undergoing chemotherapeutic treatment within the MHFV or MVAHC medical systems.
Disqualifiers
Allergy or sensitivity to probiotic supplementation
Current treatment of cancer other than non-melanoma skin cancer, including metastases and recurrences
Current participation in another interventional study of medication(s)
Major changes in eating habits within the past 3 months, such as stopping or starting a restricted diet
Trial design
Treatments tested in this trial
- Lactobacillus and Bifidobacterium
- Placebo
Treatment groups
40 Participants
are divided into 3 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov