Probiotic Supplementation During Cytotoxic Chemotherapy for Solid Tumor Malignancies

Not Applicable

Not yet recruiting

• Conditions: Solid Tumor, Adult; Cytotoxicity
• Interventions: Other: Placebo; Biological: Lactobacillus and Bifidobacterium

• Registration Number: NCT06772090
• Lead Sponsor: Masonic Cancer Center, University of Minnesota

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-02
• Study First Submitted QC: 2025-01-08
• Study First Posted: 2025-01-13
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-05
• Last Update Posted: 2025-03-06
• Study Start: 2025-04-25
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Phase 0: Placebo	Placebo	The placebo will also be manufactured and provided by the commercial provider.
Phase 1: Placebo	Placebo	Placebo capsules of the same size and shape to be taken daily for 12 weeks. The placebo will also be manufactured and provided by the commercial provider.
Phase 1: Treatment	Lactobacillus and Bifidobacterium	50 billion CFU of a commercially available Lactobacillus and Bifidobacterium oral capsule, to be taken daily for 12 weeks

Primary Outcome Measures

Name	Time	Method
Number of Participants at end of study	Week 12	Determine the feasibility of conducting a randomized, placebo controlled clinical trial of probiotic supplementation in patients with solid tumor malignancies undergoing cytotoxic chemotherapeutic treatment. Number of participants that completed the study.

Secondary Outcome Measures

Name	Time	Method
Number of Adverse Events related to Cytotoxic Chemotherapy	Week 12	To evaluate how probiotic supplementation impacts cytotoxic chemotherapy-associated GI toxicities, including nausea, anorexia, and diarrhea. Number of adverse events correlated to nausea, anorexia or diarrhea.