Carolinas HealthCare System
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CHS Receives $8 Million NIH Grant to Conduct First-Ever Study of its Kind
September 26, 2012

A research team in the Department of Oral Medicine at CHS’s Carolinas Medical Center has been awarded an $8 million National Institutes of Health (NIH) grant to study dental and oral medicine outcomes of patients who have received high-dose radiation to the head and neck region. This is the largest research grant ever awarded to CHS.
Each year 40,000 Americans develop head and neck cancer, and many have to receive high-dose radiation therapy, often in combination with surgery and/or chemotherapy. An unavoidable side effect of radiation therapy is damage to the oral and maxillofacial tissues, some of which persist for the lifetime of the patient.

These side effects include a permanent decrease in saliva production (hyposalivation), as the major salivary glands are often included in the areas treated with radiation therapy. Hyposalivation has a major impact on patients’ overall quality of life and it significantly increases the risk of caries (tooth decay) and tooth loss. Radiation can also impair bone healing, leading to a life-long risk of infection of the bone surrounding the teeth, referred to as osteoradionecrosis (ORN). This can lead to an increased risk of fracture of the jaw and severe pain that requires extensive medical and surgical therapy. It is felt that approximately 50% of all ORN cases are associated with dental extractions following radiation therapy, yet these patients are caught in a vicious cycle as they are at a high-risk of needing dental extractions.

“Currently, dental management of these patients is largely based on expert opinion and there are no evidence-based guidelines available to inform the healthcare team who manage patients before or after radiation therapy,” said Michael Brennan, DDS, MHS, Principal Investigator of this NIH study. “The data we collect will lead to a better understanding of the oral and dental sequelae experienced by these patients after radiation therapy, which will lead to protocols for patients with head and neck cancer that are based on data from this five year study.”

Head and neck cancer patients enrolled in this multi-center study will receive a standard dental assessment prior to radiation therapy, with detailed documentation of dental/oral conditions and dental management at that time. Follow-up visits will be conducted every six months for up to two years for the entire study population. Tooth loss will be documented and secondary analyses will look for risk factors for tooth loss. This information will allow for definitive documentation of the dental complications in this population, which in turn will guide decision-making and standard of care for pre and post radiation therapy dental management

In addition to Carolinas Medical Center, patients will be enrolled at Harvard University, University of Pennsylvania, New York University and the University of Connecticut. Dr. Brennan will work closely with Dr. Rajesh Lalla, Principle Investigator at the University of Connecticut. The University of Minnesota will serve as the Data Coordinating Center for this study.

“The uniqueness of the study, the size of the research grant and the reputation of Dr. Brennan’s collaborators provide clear evidence of the leading role academic and clinic research at CHS is achieving, in relation to a multidisciplinary strategy for therapeutic innovation,” said James McDeavitt, MD, Chief Academic Officer of CHS.
Dr. Brennan is the Associate Chairman at CHS’s Department of Oral Medicine and has a major interest and expertise in the management of oral complications of cancer therapy. 

He is currently President of the International Society of Oral Oncology and recently served as the Chair of the Oral Care Study Group of the Multinational Association of Supportive Care in Cancer. Through the collaboration of these organizations, he has directed significant research advances in this field, and he has organized two ongoing international studies – OraSTEM and Peds OraSTEM, which are evaluating oral complications in adult and pediatric patients treated with hematopoietic stem cell transplantation.