Probiome for Canine Bladder Cancer

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Purpose and brief explanation of the study

The purpose of this study is to determine if the addition of a probiotic can improve clinical outcomes when paired with a standard-of-care therapy (vinblastine / piroxicam) for canine bladder cancer - also known as urothelial carcinoma or transitional cell carcinoma (TCC). We will evaluate tumor response, clinical side effects, and quality of life as part of this study. Additionally, we will evaluate immune response and characterize the stool and urine microbiome and metabolome to understand the potential effects of the probiotic. Our broader goal is to improve cancer care and outcomes in dogs with bladder cancer.

What qualifies my pet for enrollment?

  • Dogs strongly suspected of having urothelial carcinoma by the referring veterinarian 
  • All cases will be biopsy confirmed at OSUCVM following initial screening
  • Cancer must be primarily located within the bladder. 
  • Female dogs must weigh at least 6kg for inclusion 
  • Males must weigh at least 10kg and be able to pass a catheter of minimum size through the urethra. 
  • Dogs must be at a normal weight (body condition score 4-7)
  • Complete blood count and serum chemistry without clinically significant abnormalities, as determined by veterinarian.

What might exclude my pet from enrollment?

  • History of chronic gastrointestinal problems, skin problems
  • Diagnosed with or treated for fecal parasites within the last three weeks 
  • Antibiotics within the last three weeks 
  • Probiotic therapy or consuming a diet or treat containing probiotics within the last three weeks
  • H2 blockers or proton pump inhibitor within the last three weeks
  • Fed a raw diet in the last three weeks
  • Any history of chemotherapy or radiation, including for previous cancers
  • Additional requirements to participate in this study that will be determined by the veterinarian based on the screening appointment.

What does enrolling my pet in this clinical trial involve?

To determine if your dog is eligible for this study, we will conduct a basic screening visit including a physical exam, blood work, chest X-rays, a fecal exam for parasites, urinalysis, and potentially a genetic test for breeds (shepherds, sheepdogs, collies, old English sheepdogs) at high risk for carrying a mutation that increases the risk of side effects with some chemotherapy drugs. All dogs enrolled will receive standard treatment for bladder cancer including vinblastine (a chemotherapeutic delivered intravenously) and piroxicam (a non-steroidal anti-inflammatory drug given daily by mouth). Half the dogs enrolled in this study will be assigned to receive a probiotic (given daily by mouth) in addition to the standard-of-care therapy. The other half of the dogs will be assigned to receive a placebo (given daily by mouth). Dogs will then undergo a standard treatment regime that includes bloodwork weekly to monitor for low white blood cell counts and IV infusions of vinblastine every 2 weeks unless contraindicated. On the first and last day of the trial, dogs will also undergo sedation/anesthesia for ultrasound and tumor measurement, cystoscopy (visualization of the inside of the bladder), biopsy (tissue collection) from the tumor, and urine collection from the bladder. Owners will be asked to provide free-catch urine and stool samples from their dog every 2 weeks and asked to complete regular questionnaires and logs of the dog's clinical signs and behavior. Owners will also be asked to provide follow-up urine and fecal samples 8 weeks after trial conclusion.

Client compensation

For dogs that meet eligibility criteria and enroll, screening and 8 weeks of medical management for your dog's bladder cancer will be covered by the study. Study medication will be provided free of charge for the duration of the study. Limited funds are also available to cover certain adverse events secondary to the treatment protocol and in accordance with your veterinary team's recommendations. Owners will be financially responsible for all costs associated with bladder cancer management after the 8-week trial period, and for diagnostics and treatments associated with presumed tumor progression.