Probiotic Supplementation During Cytotoxic Chemotherapy for Solid Tumor Malignancies

ConditionsSolid Tumor, Adult Cytotoxicity

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorMasonic Cancer Center, University of Minnesota

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults ≥18 years old

Diagnosis of stage III colon cancer

Undergoing chemotherapeutic treatment within the MHFV or MVAHC medical systems.

Disqualifiers

Allergy or sensitivity to probiotic supplementation

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

Trial design

Design model

Parallel

Treatments tested in this trial

Lactobacillus and Bifidobacterium
Biological/Vaccine
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\>).
Placebo
Other intervention
Placebo capsule manufactured in same facility as experimental capsule.

Treatment groups

40 Participants

are divided into 3 treatment groups

Group A: Phase 0: PlaceboPlacebo comparator 1 intervention

Group B: Phase 1: PlaceboPlacebo comparator 1 intervention

Group C: Phase 1: TreatmentActive comparator 1 intervention

Trial 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

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Masonic Cancer Center, University of Minnesota

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: