Probiotic Supplementation During Cytotoxic Chemotherapy for Solid Tumor Malignancies

A Randomized Placebo-controlled Feasibility Trial of Probiotic Supplementation During Adjuvant or Neoadjuvant Cytotoxic Chemotherapy for Solid Tumor Malignancies

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.

Inclusion Criteria:

• Adults ≥18 years old
• Diagnosis of stage III colon cancer
• Undergoing chemotherapeutic treatment within the MHFV or MVAHC medical systems.

Exclusion Criteria:

• Allergy or sensitivity to probiotic supplementation
• Diagnosis/history of:

Non-colon GI cancer or chronic GI-related disease or disorders such as gastric ulcer, irritable bowel syndrome, inflammatory bowel disease, or intestinal malabsorption syndrome Cognitive impairment, such as dementia, or developmental disorder that would affect ability to give consent or comply with study procedures

• 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
• BMI ≥40 kg/m2 or ≤17 kg/m2
• Unexpected change in weight of ˃4.5 kg within the past 6 months