Purpose and Brief Explanation of Study:
Cellular senescence is a phenomenon in which cells lose their ability to divide and can occur as a result of normal cellular aging or external insults, such as exposure to chemotherapy drugs. Originally thought to protective against tumor formation, cellular senescence can also have detrimental effects in the context of cancer. This is partially due to senescent cells secreting cytokines, or signaling molecules, that promote inflammation and contribute to chemotherapy resistance, toxicity and a poorer outcome in cancer patients.
Since little is known about cellular senescence in dogs, we propose a pilot study to measure cytokine concentrations in dogs with lymphoma before and after chemotherapy (doxorubicin) treatment, as a marker of induction of cellular senescence.
Objective of the trial:
This project will provide a foundation for the understanding of cellular senescence across species as well as identify possible therapeutic targets for reducing side effects and improving outcome in dogs and humans with cancer undergoing chemotherapy
What qualifies my dog for enrollment in this in this trial?
To participate in this clinical trial your dog must:
- Have a cytologic or histopathologic diagnosis of lymphoma
- Weight >8kg
- Have complete bloodwork (complete blood count, biochemical profile +/- urinalysis) to evaluate general health, diseases status and ability to receive chemotherapy treatment. Other diagnostic tests are at the discretion of the attending clinician.
- Be treated with the CHOP or doxorubicin chemotherapy protocol.
What does enrolling my dog in this clinical trial involve?
If your dog is deemed eligible to enter into the study, the following schedule of tests will be performed.
Week 1: Prior to the week 1 chemotherapy treatment, your dog will have 6 mls (slightly over 1 teaspoon) of blood drawn from the jugular vein in his or her neck. This blood sample will be used to determine your dog’s baseline cytokine concentrations. Three needle aspirates will also be performed on an affected lymph node to collect cells for future research purposes. You will also be asked to fill out a quality of life survey, which will also serve as baseline information.
Week 9 – Day 0: (CHOP patients)/Week 7 – Day 0 (Doxorubicin single agent patients): Prior to the Week 9 (CHOP)/7 (Doxorubicin) doxorubicin treatment, your dog will have 6 mls of blood drawn from the jugular vein. A physical exam and bloodwork will be performed prior to doxorubicin administration according to standard or care. Doxorubicin will be administered through an intravenous catheter over 30 minutes, according to standard operating procedures. The intravenous catheter will be flushed with saline and remain in place for subsequent blood draws. Another 6 ml of blood will be drawn from the indwelling intravenous catheter 3- and 6-hours after doxorubicin administration. After the 6-hour blood draw, the intravenous catheter will be removed.
In the event that a sufficient quantity of blood cannot be withdrawn from the intravenous catheter, the intravenous catheter will be removed and jugular venipuncture will be performed for the 3- and 6-hour sample collection. Your dog will be boarded in the oncology wards overnight, under the supervision of a ward veterinary technician. The technician will monitor your dog and administer chemotherapy-related medications as prescribed by the attending veterinarian. You will also be asked to fill out a quality of life survey at this visit.
Week 9 – Day 1: (CHOP patients)/Week 7 – Day 1 (Doxorubicin single agent patients): Twenty-four hours after doxorubicin administration, your dog will have another 6 mls of blood drawn from the jugular vein. After this blood collection, your dog will be discharged from the hospital.
Week 10: (CHOP patients)/Week 8 (Doxorubicin single agent patients): Your dog will return for his or her final blood draw one week after doxorubicin administration. A final blood draw will be performed at this visit.
Owners are responsible for costs associated with all pre-study diagnostics, including but not limited to, needle aspirate and cytology and bloodwork. Following entry into the study, all costs related to the study (Week 9: recheck exam, PC-CBC, doxorubicin, chemotherapy administration ~$270 and Week 10: recheck exam, PC-CBC ~$110) will be covered. Following your dog's completion of the clinical trial, you will receive a credit of $500 for continued treatment of your dog at the OSU VMC.
If you believe your pet may be eligible to enter this study, please click here to fill out a questionnaire.
Please contact the Clinical Trials Office at the Veterinary Medical Center for more information about this study.