Are you suffering from dry mouth caused by recent radiation therapy for cancer of the mouth, sinuses, nose, or throat?
The AQUAx study will evaluate the safety and potential effectiveness of an investigational gene therapy for dry mouth, also known as xerostomia, resulting from radiation damage to the salivary glands.
You may be eligible for this clinical research study if you are at least 18 years old and have dry mouth as a result of abnormal gland function from radiation therapy for head and neck cancer, and if you meet other enrollment criteria.
Xerostomia is a chronic and debilitating disorder of the salivary glands, in which saliva production is impaired. Xerostomia has a number of different potential causes, including radiation therapy for head and neck cancer and certain autoimmune diseases such as Sjogren’s Syndrome.
There is currently no cure for dry mouth that is caused by radiation therapy to the saliva glands. The AQUAx study is looking at an investigational gene therapy that was created to potentially address xerostomia. It is currently being studied to evaluate its safety and its potential to relieve symptoms of xerostomia. The investigational drug is designed to use a gene to restore function to cells that have been damaged by radiation treatment.
In the AQUAx study, the investigational drug is designed to restore function to certain radiation-damaged saliva glands, by injecting into the gland a gene responsible for increasing water conduction.
The investigational drug will be injected into the parotid salivary gland, inside the mouth, with the goal of producing a protein called human aquaporin-1.
Human aquaporin-1 helps with water movement across the salivary glands.
More water movement across the salivary gland may result in more saliva in your mouth and your mouth may feel less dry.
This Phase 1/2 clinical trial is enrolling participants who have been cancer-free for five or more years after treatment for head and neck cancer (or at least 2 years cancer-free if their cancer was HPV+), are suffering from grade 2 or 3 radiation-induced late xerostomia, and meet other enrollment criteria.
During the screening period, you will be invited to voluntarily sign and date the informed consent form. A study coordinator will also ensure you are eligible to participate by asking questions regarding your physical and oral health.
You will be asked to participate in at least two screening visits. The first visit will take place approximately 30 days before the injection of the investigational drug. The second visit will take place within 7 days before receiving the investigational drug injection.
During screening visits, you will take part in study-related tests, which will ensure you qualify for the study. If you meet all criteria for enrollment into the study following screening and elect to participate, you will be scheduled for administration of the study drug following the second screening visit.
On the day you receive the investigational (study) drug, you will remain at the study location for approximately 3 hours, and the study nurse will check your vital signs throughout this timeframe.
You will be asked to return to the study location 8 more times over the course of 12 months from the date the study drug is administered. At the completion of the study period, you will be invited to enroll in a voluntary, follow-up study to assess the side effects of the investigational drug for up to 5 years. You are not obligated to take part in this portion of the study.
If you participate in the AQUAx study:
Participants may qualify if they:
All current study locations are listed below and more may be added at any time. If you are interested in participating in the AQUAx study, complete the form to speak with a study representative regarding your eligibility and available study locations.
Reimbursement for reasonable travel and lodging expenses may be offered to those participating in the study.
If you do not see a participating clinic near you and you qualify for this trial, you may speak with a study representative to learn more about this service. Getting to and from your study visits should not prevent you from participating in the AQUAx study.
If you would like to learn more about the AQUAx study, fill out the form below. A study representative will contact you and answer any questions you may have. Your information will be used only for the purpose of evaluating whether you may be eligible to participate in this study unless authorized otherwise.
Clinical research studies test the safety and effectiveness of investigational drugs in humans. Through clinical research, scientists and doctors are able to gather information regarding an unapproved drug to understand its side effects and how well it may work. This information may be submitted to health agencies, such as the Food and Drug Administration (FDA) in the United States, for approval of the investigational drug at some time in the future. Participation in clinical research studies is voluntary. Volunteers may stop participation at any time.
All clinical research studies must follow strict federal laws and regulations on how volunteers are treated. For example, the informed consent form signed by study participants must be reviewed and approved by an independent ethics review committee called the Institutional Review Board. The informed consent form is required to contain information about the risks and benefits of participation. All aspects of the study will be explained to you, and you will have the opportunity to ask questions about the study and your participation. You also have the option to cease participation at any time throughout the study. However, as with any clinical study of an investigational drug, it is not possible to predict all of the potential unwanted side effects.
You have the right to leave a clinical study at any time and for any reason. If you do decide to stop participation, speak with the study doctor first to discuss how leaving may affect your health, along with other treatment options.
If you decide to take part in and are eligible for the AQUAx study, you may receive reimbursement for reasonable travel and lodging expenses. Any payment travel and lodging will not depend on you completing the study. A study representative will answer any questions regarding eligibility and documentation.
Additional information regarding this clinical research study can be found on clinicaltrials.gov or on this website.
Your participation in the AQUAx study will run for approximately 12 months from the date you have been administered the investigational drug, with an opportunity to take part in a follow-up study to assess the side effects of the study drug for up to 5 years. You are not obligated to take part in the follow-up study.
This study will be taking place in select study locations across the United States. If you are interested in participating but do not live near a study location, you may be eligible for reimbursement for reasonable travel expenses to and from a study location.