Flint Animal Cancer Center

Promote salivary gland regeneration using therapeutic delivery of cevimeline

Patient Disease:

Canine neoplasia being treated with radiation therapy

Study Name:

Promote salivary gland regeneration using therapeutic delivery of cevimeline

Purpose of the study:

  • To determine the effect on saliva production of injections of a novel drug into salivary glands treated with stereotactic radiotherapy

Primary Eligibility Criteria:

  • Dogs that will be receiving radiation therapy (any type, any multiple treatment protocol) as long as no salivary tissue is in the radiation field and there is not risk of excessive normal tissue radiation exposure

  • Weight > 12 kg (26.4 lb) and < 60 kg (132 lb)

  • Good function of liver and kidneys, acceptable blood cell counts, and free of severe underlying disease

  • No prior radiation therapy to salivary glands

  • Pets must come to CSU for all visits related to the clinical trial

Study Protocol:

  • Once enrolled, dogs will be assigned to one of four treatment groups: alginate (carrier) only, cevimeline only, alginate + cevimeline, or no injections (control)

  • A single dose of stereotactic radiation therapy will be administered to one salivary gland

  • Dogs that are assigned to one of the treatment arms will have injections of the assigned treatment into the treated salivary gland 14 days after radiation therapy

  • Saliva, study blood samples, and biopsies of the salivary gland will be collected prior to injection and at 7, 14, and 30 days post-treatment. Additional rechecks beyond Day 30 may be requested depending on the treatment arm.

Owner Responsibilities:

  • Follow appointment schedule required by study protocol

  • Payment of the costs for radiation therapy to treat their primary tumor

Financial Incentives:

  • The costs of all study-related procedures (biopsies, blood/saliva collections, radiation to the salivary gland, and injections) will be covered by the study

  • Owners will also receive a $2000 credit to their pet’s VTH account at the time of study completion