Salivary Hypofunction clinical trials

Safety of a Single Administration of AAV2hAQP1, an Adeno-Associated Viral Vector Encoding Human Aquaporin-1 to One Parotid Salivary Gland in People With Irradiation-Induced Parotid Salivary Hypofunction

Background: - Radiation can cause the parotid salivary glands to make less saliva (dry mouth). This can cause problems like infections and tooth decay. Researchers hope a new drug can help people with dry mouth caused by radiation. Objectives: - To examine the safety of AAV2hAQP1 gene therapy. To see if the drug increases saliva in people whose parotid glands have had radiation. Eligibility: - People at least 18 years of age with a history of radiation therapy for head and neck cancer. Design: Participants will be screened in 2 visits with: - medical history - physical exam - scans of the head, neck, and chest - intravenous administration of glycopyrrolate to stop saliva - saliva collections - sialogram which is a procedure in which a substance is injected in the parotid gland and X-rays are taken. - non-drug infusion - a small piece of skin being taken 3-5-day hospital stay: Participants will receive the gene infusion. The AAV2hAQP1 will be in a solution in a syringe. It will be slowly pushed into the parotid gland through the parotid duct, an opening in the mouth near the second upper molar tooth. 10 outpatient visits over 3 years. These may include: - repeats of selected screening tests, including saliva collection - blood and urine tests - oral and dental examinations - head and neck exams, including the use of a thin scope to see the back of the throat - questionnaires - a small piece of parotid tissue being taken by either a small scope through the parotid duct or by a small needle guided by ultrasound - scans of the head and neck. For some, contrast will be injected in a vein - completion of a diary about how the participant feels between visits - swabs of teeth and gums to assess the microbiome of the mouth