The AQUAx2 Study
The AQUAx2 study is a clinical research study for people with dry mouth (xerostomia) caused by radiation therapy from previous head and neck cancer. The purpose of this study is to assess the efficacy and safety of a new investigational gene transfer study drug, called AAV2-hAQP1, at helping with dry mouth resulting from radiation damage to the parotid salivary glands.
The purpose of this study is to see if the investigational gene therapy, AAV2-hAQP1 (study drug), has an effect on the amount of saliva produced and on dry mouth symptoms, and to see if it is safe and well-tolerated in people with dry mouth as a result of receiving radiation therapy for head and neck cancer.
If you qualify for the study, you will be randomly assigned to one of three treatment groups via a process called randomization (decided by chance). Two of these three groups will receive the active gene therapy (one of two different strengths of the Study Drug) and the third will receive a placebo (an inactive solution that does not contain the Study Drug). If you receive the placebo in this study, you will be offered the active gene therapy in a long term follow-up study.
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