Investigation of a Traditional Chinese Medicine Herbal Therapy as
a Palliative Treatment for Dogs with Appendicular Osteosarcoma
Sponsored by the Oncology TEAR Foundation
FOR VETERINARIANS ON THE WEBSITE:
In this pilot study we will be investigating a Chinese Herbal Formula for side effects and
benefit as a palliative treatment for dogs with appendicular Osteosarcoma.
The study is enrolling dogs who have a diagnosis of osteosarcoma based on bone
cytology or biopsy, or a presumptive diagnosis of osteosarcoma based on characteristic
radiographic changes, for which amputation and chemotherapy are being declined.
Chinese Herbal Formulas have been used as a treatment to improve quality of life in
cancer patients for centuries. Traditional Chinese Medicine treatment principles rely on
the concept of synergistic action between multiple compounds for a multi-pronged
approach to disease treatment with minimal risk of side effects. Many herbs have also
been recently investigated and shown to have antitumor, pain relieving and antiinflammatory properties.
In this trial we will be evaluating a Chinese Herbal Formula containing 10 different herbs
which have individually shown analgesic, anti-inflammatory, or antitumor properties
relevant to Osteosarcoma. Side effects, overall quality of life and survival time will be
assessed.
We will be enrolling 30 dogs. Dogs will be randomly assigned to either the “low-dose”
or “high-dose” treatment group. Patients can receive standard oral pain management as
deemed appropriate by the attending clinician during the course of the study. Patients can
also received other palliative treatments including radiation therapy and Pamidronate but
cannot receive other alternative medicine treatments such as herbal therapies or
homeopathic therapies.
*A special thanks to the following companies donating their services to support this study:
IDEXX: blood analysis and bone cytologies
Novartis: statistical analysis
Inclusion Criteria:
• Radiographic changes consistent with appendicular osteosarcoma
• Owner declines all conventional treatments other than oral pain medications
• Owner willing and able to bring pet to Pawsitive Steps (Crooks and M-59, 6 miles from
OVRS) for force plate analysis monthly (this takes about 10 minutes) and bring pet to
OVRS monthly for evaluation.
Exclusion Criteria:
• Metastatic disease
• Pathologic fracture
• Previous treatment with amputation, radiation therapy, chemotherapy or Pamidronate
for osteosarcoma
• History of non-weightbearing lameness on affected leg
• Edema of affected leg
• Concurrent medical problem with less than 6 month expected survival time
• Current untreated cruciate ligament rupture or any other orthopedic issue expected to
limit life span to <less than 6 months
• Treatment with other supplements for cancer therapy including herbs, glandular, or
homeopathic
Study Pays For ($3705-$4180 value):
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Monthly office visits ($310 value over 6 month expected study period)
Herbal formula for up to 6 months of therapy ($500-975 value over 6 months)
All CBC/Chemistry panels - at intake and monthly during study ($850 value)
Abdominal ultrasound at intake for staging ($290 value)
Thoracic radiographs (3 views) at monthly intervals ($1680 value)
Brief Anesthesia and Bone cytology with ALP staining for diagnosis ($375 value)
Owner Responsibilities:
• Costs for:
• Oncology Consultation ($125)
• Initial thoracic radiographs, three views, performed within 3 weeks of consultation
and entrance into study: can be performed at your clinic and sent with the client, or
performed at OVRS at the time of consultation
• AP and lateral radiographs of the affected leg: can be performed at your clinic and
sent with the client, or performed at OVRS at the time of consultation
• ]Repeat radiographs of the leg if there is sudden worsening of lameness concerning
for fracture
• Oral pain medications (NSAID, opiate/tramadol, Amantadine/Gabapentin, etc) as
recommended by attending clinician
• GI protectants as indicated (Famotidine, Prilosec, etc) if NSAIDS are being used
• Any other medications or medical treatments needed during the study period
• Bring patient to OVRS Oncology service for re-evaluation once monthly
• Herb container and herbal formula must be brought to each recheck for weighing
and refills
• Fill out pain assessment questionnaire at each recheck visit – this needs to be done
by the adult who has the most contact with the patient and must be filled out by the
same person each month
• Bring patient to Pawsitive Steps (1894 Starr-Batt Drive, Rochester Hills. Off M-59 and
Crooks Road approximately 6 miles from OVRS) for force plate stance analysis once
monthly
• Administer the study formula two to three times daily for the entire duration of the
study at the prescribed dosage
• Administration of oral pain medications as recommended by attending clinician
• Available for phone interviews related to the study, their pet’s condition and survival
• Release of medical records for study purposes