Probiotic Supplementation During Cytotoxic Chemotherapy for Solid Tumor Malignancies

Launched by MASONIC CANCER CENTER, UNIVERSITY OF MINNESOTA · Jan 8, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at the effects of a probiotic supplement in adults with stage III colon cancer who are receiving chemotherapy. Probiotics are good bacteria that can help improve gut health. The study aims to see if taking probiotics during chemotherapy can be beneficial for patients. Researchers will enroll 40 participants, who will be randomly assigned to either receive the probiotic or a placebo (a treatment that looks the same but has no active ingredients). This helps researchers compare the effects of the probiotic against a control group.

To be eligible for this trial, participants must be at least 18 years old, have a diagnosis of stage III colon cancer, and be undergoing treatment through specific medical systems. However, individuals with certain conditions, such as allergies to probiotics, other types of gastrointestinal cancers, or significant changes in weight recently, may not be able to participate. If eligible, participants can expect to engage in the study for a period of time, where they will either take the probiotic or the placebo while continuing their chemotherapy treatment. The trial is not yet recruiting, so interested individuals will need to wait for further announcements.

Gender

ALL

Eligibility criteria

• 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