Clinical trial aims to improve clinical outcomes for dogs with bladder cancer

Bladder cancer accounts for about two percent of all cancers seen in dogs and is estimated to affect over 60,000 dogs per year in the United States. The long-term prognosis for dogs with bladder cancer is poor – from a few months to about a year with treatment.

Researchers at Ohio State aim to change that through the launch of a two-year clinical trial that will determine if adding a probiotic (E. coli Nissle 1917) improves outcomes with a vinblastine/piroxicam regimen to treat urothelial carcinoma in dogs.

In partnership with North Carolina State University and the University of Missouri, researchers from Ohio State’s College of Veterinary Medicine, College of Nursing, and Nationwide Children’s Hospital, this multi-institutional clinical trial is slated to launch in the fall of 2022. Researchers will be recruiting 38 dogs with bladder cancer that meet specific criteria. Half of these dogs will be placed into a group that receives the probiotic and half into a group that receives a placebo. They will also be recruiting 19 healthy dogs for a probiotic control group.

“Our goal is to see if we can improve clinical outcomes by adding a probiotic into standard clinical care for dogs with bladder cancer,” said principal investigator Vanessa Hale, DVM, MAT, PhD, assistant professor of veterinary preventive medicine at The Ohio State University. “This might include reducing the frequency of urinary tract infections or urinary tract signs in dogs with bladder cancer or reducing gastrointestinal side effects from chemotherapy or NSAID treatments.”

“There is evidence in human medicine that probiotics – different than the one being tested in this study – or microbial community manipulation can also reduce tumor size and increase progression-free survival. These intriguing results demonstrate that the microbiota may be playing a key role in cancer progression and response to therapy,” Hale said.

Canine muscle-invasive bladder cancer is remarkably similar to the muscle-invasive bladder cancer that occurs in humans, which makes dogs a powerful model for understanding human bladder cancer. Humans with this form of cancer also have a poor prognosis, so anything that this team of researchers can learn about bladder cancer and treatment in dogs has the potential to benefit humans as well.

There are a growing number of studies regarding the efficacy of probiotics in cancer therapy, but very few studies are specific to bladder cancer. The results of this double-blinded, placebo-controlled, multicenter clinical trial in canine bladder cancer may provide support for pursuing probiotics as adjuvant therapy in human bladder cancer treatment.

Notably, probiotics are not FDA-regulated, so there is limited oversight and validation of the efficacy and safety of most probiotics on the market. Hale emphasizes that while specific strains of probiotic microbes may have efficacy in specific conditions or in specific individuals, this will not be the case for all probiotics. Therefore, more controlled clinical trials are needed on specific probiotic strains in specific health conditions. She adds that it is always critical to consult with your veterinarian before adding a probiotic to your pet’s diet.

This work was supported by a generous gift from a friend of the college, Duncan Alexander.

This multi-institutional clinical trial exemplifies one of the foundational principles of the college’s Be The Model® strategic plan by advancing partnerships in which we work together to address common goals.