EXPLORATORY STUDY TO DETERMINE THE EFFECTIVENESS AND SAFETY OF PERINEURAL ADMINISTRATION OF AN INVESTIGATIONAL VETERINARY PRODUCT FOR THE CONTROL OF HIND LIMB LOCO-REGIONAL PAIN ASSOCIATED WITH BONE CANCER IN CLIENT OWNED DOGS

November 20th, 2020 Posted by Oncology, Pain Management 0 thoughts on “EXPLORATORY STUDY TO DETERMINE THE EFFECTIVENESS AND SAFETY OF PERINEURAL ADMINISTRATION OF AN INVESTIGATIONAL VETERINARY PRODUCT FOR THE CONTROL OF HIND LIMB LOCO-REGIONAL PAIN ASSOCIATED WITH BONE CANCER IN CLIENT OWNED DOGS”

Investigators:

Corey Saba, DVM, DACVIM (Oncology faculty)
Michele Barletta, DVM, MS, PhD, DACVAA (Anesthesia 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:

Primary bone tumors are common in middle aged to older, large and giant breed dogs.  Pain is often the quality and quantity of life limiting factor in dogs that do not undergo limb amputation. The objectives of this study are to evaluate the safety and effectiveness of pain control of an investigational veterinary product when administered as a single perineural (around the nerve) injection in dogs with primary bone sarcomas of the pelvic limb. Dogs must have a cytology or biopsy confirmed diagnosis of bone sarcoma to be eligible for participation in this study. In addition, the following conditions must be met:

Inclusion criteria:

  • Dogs must be otherwise healthy, have adequate bone marrow and organ function, and be deemed safe to undergo anesthesia.
  • Dogs must be demonstrating refractory pain associated with this cancer at the time of screening/enrollment.
  • Prior treatment with radiation therapy and/or bisphosphonates (e.g. zoledronate) is allowed but requires a 28-day washout period before trial enrollment.
  • Owners must sign a consent form.


Exclusion criteria:

  • Dogs with bone sarcomas at sites other than the pelvic limb (back leg).
  • Dogs that have pathologic fractures secondary to the tumor.

Dogs will undergo preliminary staging tests including initial consultation and physical examination, complete blood count (CBC), serum biochemical profile, urinalysis, and review of radiographs of the affected bone. The study period is 28 days. Once enrolled into the study, the intent will be to administer one treatment while the dog is under general anesthesia. Thereafter, owners will be asked to complete outcome measurement logs and record videos of their dogs once weekly. In addition, dogs must return to UGA 2 and 4 weeks after treatment for exams and additional videos.

Owners are responsible for the costs of initial evaluation and staging. Once a dog is enrolled, the study will cover all routine costs associated with the study including office exams, scheduled lab work, anesthesia and treatment with the investigational veterinary product. Owners will be responsible for the costs of any ancillary medications. Upon completion of the study, owners will be given a $100 gift card.

 

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 efficacy of perineural an investigational veterinary product for pain control in dogs with primary bone sarcomas. We expect the treatment will be safe. Our ultimate goal is to improve the quality of life of dogs with primary bone sarcomas.

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