Probiotic Supplementation During Cytotoxic Chemotherapy for Solid Tumor Malignancies

N/ANot Yet RecruitingNCT06772090

Masonic Cancer Center, University of Minnesota40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Solid Tumor, Adult Cytotoxicity

Interventions

Lactobacillus and BifidobacteriumBIOLOGICAL

Each lot of Lactobacillus and Bifidobacterium and placebo capsules to be used in this study will undergo bioburden testing (tested as per USP \<61\>) to ensure that each lot has: * Not more than 2000 colony forming unit (CFU) of contaminating (other than the seven strains of bacteria used in the Lactobacillus and Bifidobacterium capsules) aerobic bacteria per gram or dose (whichever is greater); * Not more than 200 CFU of yeasts and molds per gram or dose (whichever is greater); and * No bile-tolerant Gram-negative bacteria, Escherichia coli, Salmonella species (in 10 gm), Pseudomonas aeruginosa, Staphylococcus aureus, and Clostridium species per gram or dose (whichever is greater; tested as per USP\<62\>).

PlaceboOTHER

Placebo capsule manufactured in same facility as experimental capsule.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Number of Participants at end of study

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.

Time frame: Week 12

Secondary Outcomes

Number of Adverse Events related to Cytotoxic Chemotherapy

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.

Time frame: Week 12

Central Contacts

Ajay Prakash, MD, PhD

CONTACT

612-624-9452 praka086@umn.edu

Data from ClinicalTrials.gov

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