1400 Telegraph Rd.
Bloomfield Hills, MI 48302
Phone (248) 334-6877
Fax (248) 334-3693
www.ovrs.com
Investigation of a Traditional Chinese Medicine Herbal Therapy as a
Palliative Treatment for Dogs with Appendicular Osteosarcoma
The objective of this clinical study is to evaluate the safety and effectiveness of an herbal formula for
control of pain related to canine osteosarcoma in dogs in conjunction with standard oral pain medications
when compared to standard oral pain medications alone.
Does my Dog Qualify for this study?
Your veterinarian can help you determine if your dog qualifies as a study participant.
Your dog may qualify if:
• He/she has changes on radiographs (x-rays) in one of the leg bones suggestive of a bone tumor
• You are not interested in any conventional treatments for osteosarcoma other than pain management
• You are willing and able to bring your pet to OVRS each month for evaluation.
You dog does not qualify if:
• The bone is fractured
• They have had any previous treatment with amputation or chemotherapy for osteosarcoma
• They have a history of non-weightbearing lameness on affected leg
• They have edema (fluid accumulation) in the affected leg
• They have a concurrent medical problem expected to limit life span to less than 6 months
• They have a current untreated cruciate ligament rupture or any other orthopedic issue expected to limit
life span to less than 6 months
• They are receiving any supplements or treatment for cancer including herbs, glandular, or homeopathic
therapies
What are the benefits of participation?
If your dog qualifies for enrollment and completes the study, the following will be provided:
 Clinical examinations, blood analyses and veterinarian fees within the context of this study and
directly relating to pain management of bone tumor related pain.
 Study formula is provided at no cost.
What procedures are required to determine eligibility and during the conduct
of the study?
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Prior to study inclusion, your dog will have blood chemistry panel performed within 3 weeks of
being enrolled in the study to determine general health as well as verify acceptability for
enrollment in the study according to the inclusion criteria. Your dog will also receive a clinical
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examination that will require disclosure of complete medical history. Only after meeting all of the
inclusion and none of the exclusion criteria will your dog be eligible to participate.
During the initial evaluation, your dog will be evaluated to determine your dog’s qualification for
enrollment in the study.
Your dog will be re-evaluated by one of the oncologists at OVRS every month, at which time
chemistry panel will be performed. At these rechecks, your dog will be evaluated for pain and
oral pain medications will be adjusted as necessary.
What are my responsibilities during the course of the study?
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You will be responsible for administering oral pain medications and study formula as directed.
The dosing of the study formula is typically twice daily (every 12 hours) or three times daily
(every 8 hours).
You will be required to transport your dog to OVRS for monthly re-evaluation.
At each monthly recheck you will be required to fill out a quality of life questionnaire. This
questionnaire must be filled out by the same person each month and that person should be the
individual who has the most contact with your dog on a daily basis.
During the course of the study your dog may not receive any herbal supplements other than those
prescribed by the Investigators.
Your dog will continue to remain in the study for life, until the end of the study period or until
your dog is unenrolled from the study by the Investigators or withdrawn from the study by you for
any reason.
You are required to continue administration of the herbal formulation as directed during the entire
time your dog is enrolled in the study.
Is the study formula safe for my dog?
The study formula is a modification of a classical traditional Chinese Medicine formula which has been in
use for centuries with no published reports of toxicity in humans or animals. Possible adverse events may
include gastrointestinal toxicity (such as diarrhea, poor appetite or vomiting) and, with most chinese herbal
therapies, are typically related to gastrointestinal irritation and resolve with discontinuation of the formula
or dose reduction.
One of the purposes of this study is to determine safety of this formula when used in combination with
routine oral pain medications such as non-steroidal anti-inflammatory drugs (NSAIDs), partial opiates like
Tramadol, and Gabapentin or Amantadine which are routinely prescribed for management of tumor related
pain in dogs. Because your dog has a bone tumor, they will be receiving routine pain management with
one or all of these oral medications. These medication all carry the possibility of adverse events
themselves.
NSAIDs may be associated with gastrointestinal (stomach/intestine), renal (kidney) and hepatic (liver)
toxicity. Sensitivity of drug-associated adverse events varies with the individual patient. Dogs that have
experienced adverse reactions to one NSAID may experience adverse reactions to other NSAIDs.