Otolaryngology Clinical Trials
Our Clinical Trials
The following is a list of the ongoing clinical trials in the department of Otolaryngology / Head & Neck Surgery. If you are interested in learning more about a trial, or would like to be a participant in the trial, please contact the trial coordinator at the number or email listed. If you have questions about our research or a clinical trial, please contact us at our email. Each division may have ongoing clinical trials. This page is kept up to date, but trials may close with little or no notice.
Click on the Division noted below to jump to the clinical trials that are ongoing for that group:
Pediatric Clinical Trials
The Pediatric Division of the Department of Otolaryngology / Head & Neck Surgery is currently working on the following clinical trials:
- Genetics of ear infections (otitis media) - enrolling participants now. Saliva sample will be collected in clinic.
- Treatment outcomes in children with hypernasal speech (velopharyngeal insufficiency)
- How children's ears are affected by cleft palate
- Sclerotherapy for lymphatic malformations
If you are interested in finding out more about any of these studies, or if you are interested in participating in one of these studies, please call 503 494-5350 to schedule a consultation with either Dr MacArthur or Dr Milczuk in our pediatric otolaryngology clinic. If you would like to know if you are eligible to participate in a study, please email Dr MacArthur.
Oregon Sinus Center
Title: Determinants of Surgical Outcomes in Chronic Rhinosinusitis (CRS)
Dates: 7/1/04-6/30/10
Description: The goal of this study is to evaluate quality of life and olfactory outcomes of sinus surgery and to develop a predictive model of surgical outcomes utilizing a multi-institutional, prospective cohort of patients with CRS undergoing sinus surgery. Study involves quality-of-life survey assessments and olfactory testing at multiple time points.
Role:Dr. Timothy L. Smith, Principal Investigator
Enrollment: Patient enrollment occurs through clinic visitations during business hours within the Oregon Sinus Center at the Center for Health and Healing during normal clinic visits. Patient enrollment took place at OHSU, Stanford University, and the Medical College of Wisconsin. OHSU is the coordinating research center.
Contact: Dr. Timothy L. Smith or Jess C. Mace, Research Coordinator
Update:Total enrollment was 518 subjects. All baseline enrollment was complete as of 4/30/2009. Study is continuing to collect postoperative follow-up through 5/31/2011, however publication efforts are ongoing. To date, this investigation has produced 34 peer-reviewed publications and 28 oral presentations at nationally recognized conferences and society meetings.
Title: A Comparison of medical therapy to medical therapy plus endoscopic sinus surgery in patients with chronic rhinosinusitis.
Dates: 8/25/2009 – 8/25/2011
Source: American Rhinologic Society
Description: A multi-institutional prospective cohort study designed to compare quality-of-life outcomes between medical and surgical treatment for symptoms of chronic rhinosinusitis (CRS). A total of 181 subjects will be enrolled at four tertiary care centers and followed for 12 months.
Role: Dr. Timothy L. Smith, Principal Investigator
Enrollment: OHSU is the coordinating research center and all enrollment activities take place within the Oregon Sinus Center at the Center for Health and Healing during normal clinic visits. Other enrollment sites include Northwestern University, the University of Pennsylvania, and the University of South Carolina. This study involves quality-of-life survey assessments at multiple time points and clinic visits.
Contact: Dr. Timothy L. Smith or Jess C. Mace, Research Coordinator
Update: All baseline enrollment is complete as of 4/15/2010. Follow-up activities have concluded as of 3/31/2011. Publication efforts are ongoing and have produced one manuscript and invited presentation to the spring meeting of the American Rhinologic Society in Chicago, IL.
Title: Determinants of Medical and Surgical Treatment Outcomes in Chronic Sinusitis
Source: National Institute on Deafness and Other Communication Disorders
Description: A multi-institutional prospective cohort study to compare quality of life outcomes between medical management and endoscopic sinus surgery for chronic rhinosinusitis. A total of 976 patients will be enrolled at several tertiary care centers around the country and coordinated at OHSU. This study also evaluates olfactory function, as well as cellular and molecular expression of patients with chronic sinus disease.
Role: Dr. Timothy L. Smith. Principal Investigator
Enrollment: OHSU is the coordinating research center and all enrollment activities take place within the Oregon Sinus Center at the Center for Health and Healing during normal clinic visits by invitation only. To date, other patient enrollment sites include the Medical University of South Carolina and Stanford University.
Contact: Dr. Timothy L. Smith or Jess C. Mace, Research Coordinator
Head & Neck Surgery / Cancer Clinical Trials
- - Theradex (IRB #5265) – This study is the first in the world to test a "live" cancer-killing virus by direct injection into recurrent head and neck cancer.
Non-Interventional
- HPV Oral Transmission Study in Partners Over Time - "HOTSPOT" (IRB #5263) – This study tests how HPV (human papillomavirus) infection may or may not be transmitted between head and neck cancer patients and spouses or significant others.
- UPCI #07-124 (IRB #5096) – This study is designed to determine how erlotinib and dasatinib (study drugs) effect tumor markers in patients with head and neck cancer.
TALC Study (IRB #5833) – The purpose of this study is to analyze swallowing function, speech function, and quality of life in patients with cancer of the larynx or hypopharynx, who will have either surgery or chemoradiation.
VTE Study (IRB #6640) – This study is being done to determine the incidence of blood clots in the lower extremities in patients with head and neck cancer after surgery.-
Interventional Treatment
Chemoradiation for Advanced-Stage Skin Cancer (IRB #5466) – The purpose of this study is to investigate the effects of two new chemotherapy drugs when combined with radiation therapy after surgery in patients with advanced-stage skin cancer.
RTOG 0920 (IRB 6918) - The purpose of this study is to investigate teh effects of treatment with radiation therapy or radiation therapy pklus the chemotherapy drug cetuximab, when given after surgery in patients with locally-advanced head and neck cancer.
If you are interested in getting more information about, or participating in, the Head & Neck Surgery / Cancer Clinical trials, email Will Stott at stottw@ohsu.edu or give him a call at 503 418-9235.
Otology Clinical Trials
Title: Fludrocortisone for Sudden Hearing Loss (IRB 6240)
Role: Anh Nguyen-Huynh, MD, PhD (Principal Investigator)
Description: The purpose of this study is to test whether fludrocortisone (a synthetic version of the natural hormone aldosterone) can treat sudden hearing loss within three months of its onset when another steroid has failed.
