Benign and malignant tumors are common in dogs, which may or may not be associated with alterations in appetite. The purpose of this study is to evaluate a novel pet food in dogs with different types of cancer who are reported by their owner to have a normal or decreased appetite. A dog may be a possible candidate for this study, if they have been diagnosed with cancer or have a benign tumor. The study will be a multi-center clinical study conducted in at least 15 general and specialty practices in the United States. The intent is to include at least 90 total evaluable dogs in this study. Clinical study sites are expected to enroll a minimum of 5-10 dogs.
Pet owners will receive the diet to feed their dog over a 28-day study period along with a scale to properly weigh the food. There is no “placebo diet”. Bloodwork will be collected on Day 1 and Day 28 for CBC and blood chemistry. Pet owners will be required to complete a daily log for the first 10 days of the study along with Day 14, Day 21, and Day 28. These logs will include an assessment of the amount of food eaten, enthusiasm for eating, quality of life, and stool quality.
Your dog will receive the study diet and bloodwork described above free of charge. If your dog has a side effect that is related to the study diet, care for this side effect will be provide at no additional cost.
Dogs are eligible if they meet the following inclusion criteria:
- Owner consent form is signed for the pet to participate in the study.
- Is at least 1 year of age.
- Is the only pet in the home OR owner agrees to feed the pet separately for the duration of study.
- All current medications (including non-prescription supplements) have been disclosed to the veterinarian/investigator and there is an understanding that changes to medication including changes in dosing may result in dismissal from the study.
- Owner is willing (at their expense) to maintain any current medications at their current dosing throughout the study without alteration and understands that any additional medications will not be reimbursed during the study unless approved or pre-approved by the study Sponsor.
- Pet treats will be limited to less than 10% of daily food offered and food is fed as directed during the study.
- Owner has a working email address, is willing to regularly check it, and consents to receiving necessary study-related communication through email.
- Owner reports owning and is proficient in using a smartphone (Android or Apple only) which is 4 years old or newer.
- Owner agrees to download and use study Apps. Pet parent(s) express that they are willing, able, and have experience setting up a Wi-Fi enabled App/device.
- Owner consents to text messaging back and forth for any necessary study-related communication/troubleshooting.
- Understanding that Wi-Fi, texting, or data cell phone charges while participating in this study will NOT be reimbursed.
- Dog has history of cancer with a diagnosis as to cancer type including determination of whether the cancer is malignant or benign. OR a presumptive diagnosis can be made at time of enrollment and diagnostics are pending.
- Dog’s owner DOES NOT elect referral for advanced therapy including interventions such as surgery, chemotherapy and/or radiotherapy where that treatment would interfere with the first 10 days of data collection and those days being free of medication except NSAIDs or topical or eye medications. Or dog is in remission.
Dogs are not eligible if they meet the following exclusion criteria:
- Has participated in any other clinical trials within the last 6 months.
- Currently in need of hospitalization for underlying disease condition(s).
- Plans scheduled surgery during the study timeframe.
- Has a major concurrent systemic disease or condition, acute traumatic injuries, or intestinal parasites.
- Has history of an unknown illness or a current illness that is not likely to obtain a diagnosis.
- Is a fractious animal.
- Is pregnant or likely to become pregnant during the trial period; the pet is lactating or nursing.
- Expected to be boarded at any point during the study period or the pet lives partially or exclusively outdoors.
- Currently receiving any therapeutic pet foods intended to manage specific disease conditions, except those for weight, dental tartar control, or those deemed acceptable.
- Is unwilling or unable to exclusively consume the study food.
- Has a history of complete surgical removal of their tumor.
- Dogs will have surgery, chemotherapy, or radiotherapy where that treatment would interfere with the first 10 days of data collection and those days being free of medication except NSAIDs.
- Dog has complete anorexia of multiple days duration and/or clinical evidence of dehydration and in need of intravenous fluid or immediate medical intervention.
- Has active case of or history of pancreatitis.
- Deemed by the veterinarian to necessitate appetite stimulating medications at the time of the first visit or is completely inappetant.
- Cancer will not have a definitive diagnosis.
- Unable to exclusively consume the study food due to an oral tumor or advanced gingivitis or has painful, infected teeth.
- Has a nasal tumor that might interfere with his/her sense of smell.
Chippens Hills Veterinary Clinic
595 Clark Ave
Bristol, CT 06010
Friendship Hospital for Animals
4105 Brandywine St, NW
Washington, DC 20016
Kindness Animal Hospital
2130 University Blvd
Wheaton, MD 20902
Quakertown Veterinary Clinic
2250 N. Old Bethlehem Pike
Quakertown, PA 18951
Veterinary Cancer Group
2887 Edinger Ave
Tustin, CA 92780
Additional study sites coming soon!
If you are interested in enrolling your pet or being an Investigator on this study, please contact ACI at https://www.animalci.com/contact/ or call (301) 841-0014.