Probiotic Supplementation During Cytotoxic Chemotherapy for Solid Tumor Malignancies

University of Minnesota (UMN)

Status: Begins enrollment in 10 months

Conditions: Solid Tumor, Adult; Cytotoxicity

Treatments: Other: Placebo; Biological: Lactobacillus and Bifidobacterium

Study type: Interventional

Funder types: Other

Identifiers

NCT06772090

2023LS220

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 3 patient groups, including a placebo group

Phase 0: Placebo

Placebo Comparator group

Description:

The placebo will also be manufactured and provided by the commercial provider.

Treatment:

Other: Placebo

Phase 1: Placebo

Placebo Comparator group

Description:

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.

Treatment:

Other: Placebo

Phase 1: Treatment

Active Comparator group

Description:

50 billion CFU of a commercially available Lactobacillus and Bifidobacterium oral capsule, to be taken daily for 12 weeks

Treatment:

Biological: Lactobacillus and Bifidobacterium