Title: Canine Bladder Cancer Probiome Trial – Can probiotics improve clinical outcomes? Addition of probiotic Escherichia coli Nissle 1917 to a vinblastine / piroxicam protocol for the treatment for urothelial carcinoma in dogs

Investigators:
Corey Saba, DVM, DACVIM (Oncology faculty)

If interested, please have your primary veterinarian request additional information through the UGA Oncology service by calling the small animal referral coordinator at 706-542-5362.

Study description:
This randomized, open label, placebo controlled-clinical trial is designed to evaluate the safety and potential efficacy of a probiotic when combined with vinblastine and piroxicam for the treatment of transitional cell carcinoma (aka urothelial carcinoma or UC) in dogs. Dogs must have a bladder mass that is sonographically suggestive of UC and a positive BRAF test and/or cytology or biopsy confirmed diagnosis of UC to be eligible for screening and possible participation in this study. In addition, the following conditions must be met:

Inclusion criteria:

1. Female dogs must weigh ≥ 6 kg (13.2 lbs) and male dogs must weigh ≥ 10 kg (22 lbs).
2. Dog must be treatment naive (untreated).
3. Dogs must be otherwise healthy and have adequate bone marrow and organ function.
4. Dogs must have at least one measurable lesion (tumor) with a longest diameter of ≥ 2 cm.
5. Dogs cannot have a history of chronic gastrointestinal or skin conditions nor been treated with antibiotics for 3 weeks prior to trial screening. All medications, including supplements, and diets must be approved by the investigator prior to enrollment and throughout the trial.
6. Owners must sign a consent form.

Dogs will undergo clinical screening at UGA. Preliminary staging tests will include initial consultation, physical examination, complete blood count (CBC), serum chemistry, urinalysis, fecal examination, thoracic radiographs, and abdominal ultrasound. Additionally, urine and stool samples will be collected and saved for future analysis. Once deemed eligible for enrollment, dogs will undergo cystoscopy, and biopsies of the bladder mass will be collected. Thereafter, the intent will be to administer the vinblastine at UGA once biweekly for 4 treatments total, along with piroxicam and probiotic or placebo at home. Once the treatment course has been completed, cystoscopy and biopsies will be repeated, and dogs will be eligible to receive other treatments for UC, but they will be asked to return to UGA 8 weeks later for a final study visit. The total treatment period is 56 days and the entire study period is 112 days.

Once enrolled in the study, all subsequent associated diagnostic and treatment costs, including cystoscopy, will be covered. Owners will be responsible for the cost of each office exam, along with any medications, diagnostics, hospital visits, etc. not required as part of the study.

Duration of study:
The study is currently OPEN.

Potential benefits to veterinary medicine:
This trial is expected to provide valuable information about the safety and potential efficacy of a probiotic when combined with vinblastine and piroxicam for the treatment of canine bladder cancer. Our ultimate goal is to improve the quality and quantity of life of dogs with cancer.