WSU Cougar Head Logo Washington State University
Veterinary Teaching Hospital

The Pharmacokinetic of Capecitabine in Cancer-Bearing Dogs, Part 2

Purpose of Study

Canine malignant cancers are a devastating reality to many dog owners. Treatment options are often limited by pet behavior, owner finances and time commitments, and availability of veterinarians who can safely administer chemotherapy. Oral chemotherapy has become increasingly popular because it often costs less than injectable chemotherapy and can be given in the comfort of the patient’s home.

Capecitabine is a well-tolerated, oral chemotherapy drug used in humans for a wide variety of carcinomas including breast cancer, colorectal cancer and head and neck carcinomas. This chemotherapy drug has a short half-life in humans, allowing for quick dose adjustments if side effects are noted. During the first part of this study, we measured the levels of capecitabine in the blood after a single dose was given and looked at how well dogs tolerated the drug. All five enrolled dogs with advanced tumors tolerated capecitabine well and two had stable disease while on this chemotherapy drug.

The purpose of this second part of the study is to learn more about tumor response to capecitabine in a larger number of dogs. We hope that this study may provide support for the use of oral capecitabine chemotherapy in dogs with carcinomas.

Benefits

Once your dog is enrolled, this study covers the cost for 28 days of capecitabine, study-related oncology recheck examinations, and study-related lab work and imaging (if imaging is deemed necessary for tumor measurement). If your dog tolerates capecitabine well, you have the option of continuing this drug outside of the study, at your own expense, and under the supervision of your WSU Veterinary Oncologist.

It is possible that your dog’s carcinoma will not respond to treatment with capecitabine, however your dog’s participation in this study will help us explore which types of carcinomas are most responsive to this oral chemotherapy drug.

Enrollment Requirements

This study is being conducted dogs that have been diagnosed with a carcinoma. Dogs may be of any age, breed and gender. To be eligible for this study, dogs must have an appointment with the Oncology Service at the WSU Veterinary Teaching Hospital (WSU VTH) for confirmation/diagnosis of their disease and possible treatment. Dogs enrolled in this study must have a CBC and Serum Chemistry within 2 weeks of enrollment, more than 2,800 neutrophils, and no evidence of any other major disease that would result in a life expectancy of one week or less.

Treatment Methods

This study involves giving oral chemotherapy, on a set schedule, to your dog at home and 2-3 visits to the WSU Veterinary Teaching Hospital: the baseline day, rest-period blood work, and the final study day.

Baseline Day: Once enrolled in the study, if your dog does not have current blood work, blood will be drawn for a complete blood count (CBC) and serum chemistry. We will record measurements of your dog’s tumor, which may require imaging (X-ray, ultrasound, CT) and do a quick test to look at your dog’s eyes. Your dog will be sent home with 28 days of capecitabine, instructions, and a daily health log.

Capecitabine Administration Period: At home, you will give your dog capecitabine for 14 consecutive days. Days 15-21 you will NOT give capecitabine to your dog. During this period, we highly recommend that your dog has a CBC and examination. This can be done with your regular veterinarian or at the WSU VTH (if done at the VTH, the study will pay for associated charges). After the 7-day rest period, you will give your dog capecitabine for another 14 consecutive days.

Final Study Day: Within 3 days of the last dose of capecitabine, your dog will return to the WSU VTH for a physical exam, eye exam, recheck blood work and tumor measurement. After this appointment, your dog’s study enrollment will be completed.

Owner Responsibilities

Owners are responsible for bringing their dog to the WSU VTH for the oncology appointment. They are responsible for the costs associated with the diagnosis of their dog’s carcinoma. To be enrolled in this study, owners must be willing to follow instructions/safety protocols to give their dogs an oral chemotherapy drug at home, complete a daily log of their dog’s health while on the drug, and return to the WSU VTH for the final study day.

Contact Information

Valorie Wiss
Clinical Studies Coordinator
509-335-0798
v.wiss@wsu.edu

Effect of N-acetylcysteine in dogs with spinal cord injury – a prospective, blinded clinical trial

Purpose of Study

Spinal cord injury is a common problem in veterinary medicine. In severe cases, spinal cord injury can lead to permanent loss of sensation, paralysis, urinary and fecal incontinence, and, in some cases, death. N-acetylcysteine (NAC) is an antioxidant commonly used in veterinary medicine for the treatment of acetaminophen toxicity. In clinical studies NAC has been shown to have valuable effects for humans and laboratory animals with spinal and brain injuries. NAC is affordable, has little to no adverse side effects, and has a wide margin of safety. The purpose of this study is to evaluate whether NAC helps to lower the biomarkers of spinal cord injury and oxidative stress and aid in the recovery of dogs with spinal cord injuries.

Benefits

By participating in this study, you and your dog will be contributing to potentially groundbreaking research that will help determine if N-acetylcysteine can help dogs such as yours with spinal cord injuries. Dogs enrolled in this study will receive the assigned study treatment (either NAC or placebo) at no cost to their owners.

Enrollment Requirements

  • To participate in this study, dogs must present to the WSU Veterinary Teaching Hospital (WSU VTH) within 72 hours of the onset of their non-ambulatory status.
  • Eligible dogs must be diagnosed (either before or after arriving at the WSU VTH) with intervertebral disc extrusion, fibrocartilaginous embolic myelopathy, or acute non-compressive nucleus pulposus extrusion in the thoracolumbar spine.
  • For this study, dogs can be of any age or weight.

Treatment Methods

Once enrolled, your dog will be randomly assigned to one of two groups: the study group (which will receive NAC) or the control group (which will receive a placebo). All dogs will receive their assigned treatment intravenously starting from the time of MRI/CT diagnosis, then every 6 hours for a total of 7 treatments and will need to remain at the WSU VTH for the duration of these treatments (approximately 48 hours). Blood and urine will be collected prior to the first treatment and two hours after the last treatment to measure biomarker levels.

Owner Responsibilities

  • Owners must bring their dog to the WSU VTH for an appointment with the Neurology Service, or through the Emergency Service in order for their dogs to qualify for this study. Treatment for this study will only be administered at the WSU VTH and cannot be done at any other veterinary clinic.
  • Owners are responsible for the costs associated with routine diagnostic testing, surgery, and hospitalization of their dog

Contact Information

Dr. Sarvenaz Bagheri
Resident in Neurology & Neurosurgery
509-335-0711
sarvenaz.bagheri@wsu.edu

Development of a Cytochrome P450 Phenotyping Test to Quantify Breed and Genetic Differences in Drug Sensitivities in Dogs

Purpose of Study

Adverse reactions to therapeutic drugs are a common and serious concern in veterinary medicine. These adverse reactions can be due, in part, to the speed at which a dog’s body is able to break down a drug. Like humans, each dog is unique in the way they ‘handle’ drugs. The purpose of this research is to develop a novel drug sensitivity test using blood or urine samples taken after giving a single, low-dose combination of three drugs.* Based on the amount of drug and drug breakdown product measured in the blood or urine, we will be able to determine whether a dog is a slow, fast, or normal processor of drugs (these measurable/observable characteristics are called a phenotype). Knowing a dog’s drug processing phenotype could help a veterinarian make an individualized drug treatment decision for that dog—such as whether to increase or decrease a drug dosage or whether to use an alternative drug.

*In a previously completed safety study, we identified a low-dose drug combination (three FDA-approved drugs) that could be safely given to dogs to measure drug metabolism without adverse effect

Benefits

Aside from a free physical exam, there is no direct benefit to your dog for participating in this study. However, this project is intended to advance the development of a test that could help all dogs receive safer, more effective drug therapies.

Enrollment Requirements

Eligible dogs must be healthy, not taking any medications, comfortable at the veterinary clinic, and 1-12 years of age. This study is recruiting dogs weighing between 11-176 pounds. Dogs must be amenable to receiving oral medications and cooperative for examinations, including blood and urine collection.

Treatment Methods

Prior to enrollment in the study, we will review your dog’s medical history with you to make sure it is eligible to participate in the study. If the medical history review indicates your dog is healthy, we will work with you to arrange a study appointment at the WSU Veterinary Teaching Hospital (WSU VTH) in Pullman, WA. On the morning of the appointment, we will first give your dog a physical examination to confirm that it is healthy and eligible for the study. If we find something upon physical examination that would exclude your dog from the study, we will let you know and you will be free to take your dog home at that time. If the physical exam confirms that your dog is healthy and qualified for the study, we will proceed with the following study protocol:

  • After the physical exam, dogs will be assigned to a kennel and will be offered their morning ration of food, in addition to water. After one hour, we will remove any remaining food. Your dog will continue to have free access to water for the day.
  • Two hours after your dog finishes eating, we will give your dog the following medications, orally: bupropion, dextromethorphan, and omeprazole.
  • Blood samples (less than 1 teaspoon) will be taken from a peripheral vein twice during the study visit: prior to drug administration and four hours after receiving the drug.
  • Urine samples will be taken twice during the study visit via free catch: prior to drug administration and six hours after drug administration

Six hours after receiving the study drugs and nine hours after arriving at the VTH, your dog will be available to go home with you.

Owner Responsibilities

If your dog is not a current patient at the WSU VTH, you are responsible for informing us of your dog’s medical history. We will ask you to provide us with a list of any prescribed or over-the-counter drugs or supplements your dog is currently taking. You will need to bring your dog, along with its morning ration of food to the WSU VTH for a one-day visit (for a period up to 9 hours). It is not necessary for you to stay at the study site for the duration of this period.

Contact Information

Valorie Wiss
Clinical Studies Coordinator
509-335-0798
cell: 509-432-5345
vwiss@vetmed.wsu.edu

General anesthesia effects on cageside ultrasound-assessed gastric motility parameters in healthy dogs

Purpose of Study

The purpose of this research is to demonstrate that a cageside ultrasound unit is a reliable diagnostic tool to assess stomach movements when patients are laying on their side, and that it will detect any decrease in stomach movements after anesthesia.

Benefits

Dogs enrolled in this study will receive free deworming medication, a physical examination, specific bloodwork screening, and costs associated with the cageside ultrasound testing: sedation, placement and food for a nasogastric tube (NG tube) and x-rays (approx. value $295-400). In addition, upon completion of the study, owners will receive a $100 credit towards their dog’s bill.

Enrollment Requirements

This study is recruiting healthy, friendly, male dogs weighing 11-44 pounds and with a body condition score of less than 7/9. To be considered for this study dogs must be scheduled for a neuter with the WSU Veterinary Teaching Hospital (WSU VTH) Community Practice Service. Dogs enrolled in this study must have normal blood work (provided by study screening) and be comfortable lying on their side for a few minutes at a time.

Treatment Methods

Dogs who appear to be eligible for this study will be given a dewormer 1 week before their scheduled neuter. On the morning of the neuter, each dog will receive a thorough physical exam and blood testing to ensure that they are healthy. After successfully passing the screening, dogs will be sedated to facilitate the placement of an intravenous catheter and an NG tube. An NG tube is a tube that goes from the nose to the stomach. NG tube placement will be confirmed with chest x-rays. Once awake we will make sure the dog’s stomach is empty and measure baseline stomach movements using the cageside ultrasound unit. We will then administer food through the NG tube and measure stomach movements again. Once these measurements are taken, we will aspirate the tube to remove food from stomach and dogs will be anesthetized and neutered according to standard-of-care protocols. After surgery, stomach movements will be measured with cageside ultrasound at specific timepoints and then the NG tube will be removed. Dogs will remain hospitalized overnight and then discharged to their owners the next morning. Once discharged, each dog’s study participation will be complete.

Owner Responsibilities

Dogs who appear to be eligible for this study will be given a dewormer 1 week before their scheduled neuter. On the morning of the neuter, each dog will receive a thorough physical exam and blood testing to ensure that they are healthy. After successfully passing the screening, dogs will be sedated to facilitate the placement of an intravenous catheter and an NG tube. An NG tube is a tube that goes from the nose to the stomach. NG tube placement will be confirmed with chest x-rays. Once awake we will make sure the dog’s stomach is empty and measure baseline stomach movements using the cageside ultrasound unit. We will then administer food through the NG tube and measure stomach movements again. Once these measurements are taken, we will aspirate the tube to remove food from stomach and dogs will be anesthetized and neutered according to standard-of-care protocols. After surgery, stomach movements will be measured with cageside ultrasound at specific timepoints and then the NG tube will be removed. Dogs will remain hospitalized overnight and then discharged to their owners the next morning. Once discharged, each dog’s study participation will be complete.

Contact Information

Valorie Wiss
Clinical Studies Coordinator
509-335-0798
cell: 509-432-5345
vwiss@vetmed.wsu.edu

Mesenchymal stem cell therapy of dogs with insulin-dependent type 1 Diabetes Mellitus

Purpose of the Study

The purpose of this study is to determine whether transplantation of insulin-producing canine mesenchymal stem cells is safe and effective in curing insulin-dependent diabetes mellitus, or significantly reducing your dog’s need for insulin. In addition, we wish to determine if this treatment can prevent or reverse diabetes-related organ damage for dogs treated with insulin. While this treatment has not yet been given to dogs, preclinical studies on rats and mice have shown these cells to be safe and effective in reversing insulin-dependent diabetes mellitus.

Benefits

You will not be charged for any treatment associated with this study. The sponsor, SymbioCellTech, will pay for the diagnostic tests to see if your dog qualifies for this study and all treatment and follow-up related costs. You will be provided with a glucometer, a spring-loaded lancet device and sufficient test strips for monitoring glucose, as well as any needed insulin for your dog during the three-year follow-up period. In addition, you will receive mileage reimbursement, at $0.55/mile, to help cover study-related travel expenses to and from WSU’s Veterinary Teaching Hospital.

Enrollment Requirements

This study is accepting dogs that have been diagnosed with diabetes mellitus and are on an established insulin and diet plan to control their diabetes. Dogs can be any age as long as they are between 11-26 lbs. They should be healthy enough to undergo a brief period of heavy sedation or general anesthesia and be free of other systemic diseases. They should tolerate restraint for collection of blood and urine specimens, and tolerate blood glucose monitoring at home (you can watch YouTube videos for “at home glucose monitoring in dogs” to see what this entails). Dogs accepted into this study cannot be pregnant or have a history of cancer.

Treatment Methods

Prior to treatment, your dog will undergo a physical exam, an abdominal ultrasound and, if your dog is 9 years or older, he/she will receive chest x-rays to make sure there are no pre-existing abnormalities. Blood and urine samples will be taken and your dog will be assessed for the presence of cataracts, neurologic damage and other diabetes-specific organ damage.

On the day of treatment, your dog will either be briefly anesthetized or adequately sedated. Your dog’s abdomen will be shaved and sterilized and, using ultrasound guidance, a catheter will be used to slowly infuse insulin-producing, sterile cells into your dog’s abdominal cavity. Once treatment is completed, your dog will be carefully monitored until determined to be stable and fully awake. At that time, your dog will be allowed to return home with you.

Your dog will be followed for three years after treatment. You will be required to record your dog’s weight, blood sugar values, insulin dose and food and water intake on a pre-determined schedule. This study requires follow-up appointments at specific times when your dog will receive physical exams, blood testing, and other diagnostic tests necessary to assess how your dog is responding to therapy.

Owner Responsibilities

Owners need to be willing to bring their dogs to WSU’s Veterinary Teaching Hospital for a minimum of 17 visits over a 3-year period. They must be willing/able to use a glucometer to track their dog’s blood glucose levels at home and to fill out study-provided tracking sheets and other paperwork associated with the study. Owners are responsible for the costs associated with the initial diagnosis of their dog’s diabetes and the initial insulin and food required to get their dog’s diabetes under control.

Contact Information

Valorie Wiss
Clinical Studies Coordinator
509-335-0798
cell: 509-432-5345
vwiss@vetmed.wsu.edu

Determining the Prevalence of Hypersomatotropism in a North American Cohort of Diabetic Cats

Purpose of the Study

Diabetes mellitus is common in cats and its prevalence appears to be increasing in the United States. While the prognosis for cats with controlled diabetes is generally good, there is a population of diabetic cats that receive insulin and still have persistently high blood glucose levels. Cats that receive an insulin dosage greater than 1.5 units/kg/dose and still have high blood glucose are considered insulin resistant.  One potential cause of this insulin resistance is a pituitary tumor (often benign).  A mass on the pituitary can cause the gland to overproduce growth hormone, a condition called hypersomatotropism (HST).  HST can lead to diabetes and acromegaly, a term used to describe physical characteristics such as broad facial features, a protruding lower jaw and enlarged paws or legs.  A recent study showed that 25% of diabetic cats in the United Kingdom have HST and, of those cats, approximately 90% have a pituitary tumor.  The goal of this study is to determine the prevalence of HST and pituitary tumors in insulin-dependent diabetic cats in the Pacific Northwest.

Benefits

Enrolled cats will receive free fructosamine and IGF-1 blood tests.  Cats with an elevated IGF-1 will receive a free CT scan +/- MR imaging.  If their cat is found to have a pituitary tumor, owners will receive a free consultation with a boarded specialist to review treatment options.

Enrollment Requirements

Enrolled cats must be insulin-dependent diabetics that are healthy enough to undergo sedation and/or general anesthesia for diagnostic imaging.  Cats that have received steroids within 6 months of blood tests will not be eligible for this study.

Treatment Methods

Once enrolled in this study, you will take your cat to your family veterinarian for a routine blood draw. This blood will be submitted for two blood tests: a serum fructosamine level, to help us determine how well your cat’s diabetes is controlled, and an insulin-like growth factor level (IGF-1), to help us determine how much growth hormone the pituitary is producing.  If the IGF-1 indicates that your cat has an elevated level of growth hormone, we will make an appointment with you to bring your cat to the Washington State University Veterinary Teaching Hospital (WSU VTH) in Pullman, Washington for a CT scan to screen for a pituitary tumor.  On the day of the CT scan, your cat will be sedated and an IV catheter will be placed so we can administer a contrast agent for the scan.  Your cat will be monitored closely while the CT scan takes place.  After the scan is finished, we will review the imaging.  If your cat’s pituitary does not look enlarged on CT, then a magnetic resonance (MR) image will be done on the same day.  If an MR image is needed, we will take your cat directly to the MRI where s/he will receive general anesthesia. Your cat will again be monitored very closely during the MR imaging process.  The CT scan and MR imaging are both outpatient procedures, so once your cat is awake, s/he will be released to go home with you.

Owner Responsibilities

Owners are responsible for the costs associated with travel to WSU’s Veterinary Teaching Hospital in Pullman, Washington for diagnostic imaging IF testing shows that their cat has an elevated IGF-1.  If imaging shows their cat has a pituitary tumor and they decide to treat, owners are responsible for the costs associated with treatment of that pituitary tumor.

Contact Information

Valorie Wiss
Clinical Studies Coordinator
509-335-0798
cell: 509-432-5345
vwiss@vetmed.wsu.edu

Effect of Gabapentin on Cardiovascular Parameters in Cats

Gabapentin is an oral medication commonly given to cats for sedation or prior to veterinary visits to reduce their anxiety. While there are currently no known side effects in cats, this medication does tend to lower their heart rates, which can be detrimental to cats with heart conditions.

The purpose of this study is to evaluate the effect of gabapentin on feline heart function. If our study finds that gabapentin affects the function of normal cats significantly, judicious use of this medication will be recommended for cats with known or suspected cardiac disease.

Benefits

Cats in this study will receive a physical examination, two blood pressure checks, two echocardiograms and two electrocardiograms (ECG). The approximate value for these procedures is $866.00.

Enrollment Requirements

This study is being conducted in clinically healthy cats between 1 and 7 years of age and at least 8.8 pounds. Enrolled cats cannot be on any medications other than heartworm, flea and tick preventatives. Successful candidates for this study must be reasonably comfortable with veterinary visits and amenable to receiving oral medication.

Treatment Methods

There are three appointments necessary for this study, spanning approximately three weeks:

Study Screening: At this appointment, we will do a physical examination and very brief echocardiogram to make sure your cat qualifies for the study. If your cat qualifies, we will send you home with study instructions and medication (either gabapentin or a placebo).

Study Appointment 1: 1-2 hours prior to arriving for this appointment, you will give your cat the study medication dose. At this appointment, we will measure your cat’s blood pressure and do an echocardiogram and an ECG. At the end of this appointment, we will send you home with study medication (whichever medication your cat did not receive the first time).

Study Appointment 2: 1-2 hours prior to arriving for this appointment, you will give your cat the study medication dose. At this appointment, we will measure your cat’s blood pressure and do an echocardiogram and an ECG. At the end of this appointment, your cat will have completed the study.
This is a double-blind study so you and the investigators will not know which medication your cat is receiving for each appointment. Cats will be randomized to receive either gabapentin or the placebo first and will receive the opposite study medication at the second study appointment.

Owner Responsibilities

Owners are responsible for bringing their cat to the WSU VTH for the three study appointments. To be eligible for this study, owners must be able to a) give their cat pills at home and b) carefully follow a written study timeline.

Contact Information

Valorie Wiss, Clinical Studies Coordinator
509-335-0789
v.wiss@wsu.edu

CSF Metabolomics in idiopathic epileptic dogs and meningoencephalitis of unknown etiology

Purpose of the Study

This study is designed to identify and profile cerebrospinal fluid (CSF) differences between healthy dogs and dogs with seizure disorders not caused by tumors or other structural abnormalities.

Metabolomics is the study of very small molecules, known as metabolites, found in biological fluids, tissues, and cells. For this study, we will look at the metabolic profile in populations of “normal” dogs and compare those to dogs with specific seizure disorders that are considered less responsive to medical treatment: idiopathic epilepsy, meningoenceopalomyelitis of unknown etiology (MUE), and seizure-like diseases such as “fly biting syndrome” and movement disorders. Our is to discover whether specific CSF metabolic profiles exist, for each of these diseases, which can offer a better understanding of the underlying cause and an explanation for the altered response to medical treatment. In addition to gaining more knowledge, we hope that this study will lead to future studies that explore new, more effective treatments.

Benefits

By participating in this study, you and your dog will be helping us learn more about diseases that are traditionally difficult to treat.

Enrollment Requirements

This study is being conducted in dogs that weigh more than 5lbs. To be eligible for this study, dogs must have an appointment with the Neurology Service at the WSU Veterinary Teaching Hospital (WSU VTH). Dogs enrolled in this study must suffer from seizures and have no sign of a tumor or other structural abnormalities.

Treatment Methods

Dogs in this study will be at the WSU VTH for an appointment with the neurology service because they are having seizures. By nature of their appointment, these dogs will already be scheduled for a neurologic exam, blood work and a spinal tap. Once the spinal tap is completed, study participation is complete.

For the spinal tap, dogs will be anesthetized and routinely monitored by an anesthesiologist. A 3×3 square-shaped area will be shaved and cleaned on the back of the dog’s head prior to the tap. Using a standardized sterile technique, a board-certified neurologist will obtain CSF.

*This study will be making use of the CSF and blood leftover after laboratory testing for your dog’s appointment has been completed. No extra CSF or blood will be drawn for this study.

Owner Responsibilities

Owners are responsible for bringing their dog to the WSU VTH for the appointment. They are responsible for the costs associated with the diagnosis of their dog’s seizure disorder, including the cost of the anesthesia necessary for the spinal tap procedure.

Contact Information

Dr. Yael Merbl
Assistant Professor, Neurology and Neurosurgery
509-335-0711 
yael.merbl@wsu.edu