Cytotoxicity, Solid Tumor, Adult
Conditions
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.
Interventions
BIOLOGICALLactobacillus and Bifidobacterium
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\>).
OTHERPlacebo
Placebo capsule manufactured in same facility as experimental capsule.
Sponsors
Masonic Cancer Center, University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Contacts
CONTACTAjay Prakash, MD, PhD
Outcome results
None listed