GENERAL INFORMATION
Study Purpose
The purpose of this study is to evaluate a protocol using herbal medicines, medicinal mushrooms and vitamin D in dogs after surgery to remove a bleeding hemangiosarcoma tumor of the spleen in order to determine whether it is effective at improving survival time over surgery alone.
Preliminary data suggests that this treatment may provide improved survival times compared to chemotherapy treatment and the number of patients living to 1 year may be longer. This study will help us determine if these promising preliminary findings are repeatable when a larger number of patients are evaluated.
STUDY CRITERIA
Requirements for Enrollment
The study requires that a biopsy diagnosis of splenic hemangiosarcoma (hemangiosarcoma of the spleen) has been achieved through surgical removal of the spleen and biopsy. Only dogs with a spleen tumor which had ruptured (causing internal bleeding), was surgically removed and has no visible spread to any other organs are potential candidates for enrollment. In order to qualify, your pet must be enrolled and starting treatment with the herbal protocol within 3 weeks of spleen removal.
A consultation with one of our participating veterinary oncologists is required in order to determine if your pet is a candidate for this study. You must be physically present with your pet for consultation. At that time, additional tests needed to determine if your pet is a candidate for the study will be discussed with you. Required tests include full bloodwork, abdominal ultrasound and chest radiographs.
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If your pet qualifies for enrollment, they will be enrolled that day so you can start treatment right away.
STUDY BENEFITS
What will You and Your Pet Receive
You will receive the clinical study herbal formula and all study supplements free of charge. These will be dispensed to you at each monthly visit. Every other month, serum vitamin D level will be monitored through a blood test, which is also provided to you free of charge. Two of the trial centers (Michigan and California) are, additionally, collecting monthly blood samples for monitoring of CRP/TK1 levels at no charge to you.
These benefits are provided for the life of your pet, up to a maximum of 12 months. After 12 months, the herbal medicine and supplements are available to you for purchase if your pet is still doing well and you wish to continue these treatments. The option to purchase the clinical study herbal formula is only available to those pets who have been enrolled in the clinical trial.
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Funding for this clinical trial is made possible through an American Holistic Veterinary Medical Foundation (AHVMF) research grant and generous donations from Natural Path and Rx Vitamins.
PET PARENT COMMITMENT
What are Your Responsibilities During the Course of the Study
In order for the treatments to work, and for our data to be accurate and helpful for other pets and pet parents in the future, your pet must receive all components of the study protocol, consistently, every day.​ That means you must be able to administer multiple supplements (both pill and powder form) twice daily for the duration of the study. You must also be available to bring your pet for monthly rechecks at your clinical trial center for physical exams, blood sample collection and herb/supplement refills.
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For an average 60-80 pound dog, the protocol will require administration of approximately:
1-2 herbal capsules twice daily
1 tsp of two different powder formulas twice daily (mixed in a treat food)
Liquid Vitamin D3 supplementation in meal food
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*Dogs who resist being medicated, or pet parents who experience stress related to medicating their dogs, are not good candidates for this study. Most herbs with anticancer action have a bitter flavor that some dogs may not enjoy. Although many accept them mixed in a flavorful treat food.
This is a partially funded clinical trial. The funding Dr. Bannink has acquired through an AHVMF grant and generous donations from Natural Path Herbs, Rx Vitamins and VDI labs allows us to provide the clinical trial herbal formula, supplements and blood tests associated with the study to 50 dogs free of charge. You will be financially responsible for all other costs associated with your pet's care and monitoring.
