Doctors, scientists and healthcare professionals gather information about new medicine and treatments from clinical trials—and your participation can complement international research. 

Written by Natalie Miller-Moore

Therare many compelling reasons to participate in a clinical trial, whether it’s to help advance science or widen your treatment options. Yet there remains a fear factor about clinical trials, which seems to stem mainly from a lack of understanding about how they work.

When you think of “clinical trials,” you might have a vision of being shipped off to an old-time hospital ward. But in reality many of the trials conducted today can be done right in your doctor’s office, where they monitor you and record your results.

Depending on the type of trial, you may receive either the drug being tested or a placebo (a similar method of delivery but no active medication). Assignments to either group are usually random. In many cases, a double-blind trial method is used, where neither the doctors nor the patients know whether they are getting the test medication. To protect your confidentiality, you may be identified by a study number rather than your name in the reports.

Clinical trials are tightly controlled to ensure patient safety and accurate results. Your dosages and side effects are closely monitored, and if your health is in danger, you can stop participating. Trials have four phases: the first phase is for general safety and the smallest, and the second and third expand the number of participants. The fourth phase is the continued collection of information about the drug or device after it is approved by the Federal Drug Administration (FDA), with additional side effects or results noted.

Participating in a clinical trial may come with some risks, but the reasons to participate are many. Medicine is advancing at an increasing rate, in no small part because of people willing to see what works and what doesn’t through the clinical trial process. Many clinical trials measure new medications, dosages, devices or combinations of medications—but a trial can also measure any method of medical care delivery, prevention or techniques.

Check with your physician or hospital to see what clinical trials they may be participating in. Here’s a sample of studies that are happening locally:

Advanced Heart Failure      
WILLIAMSBURG & HAMPTON ROADS
The “Left Atrial Pressure Monitoring to Optimize Heart Failure Therapy Study” (LAPTOP-HF) is testing an implantable device designed to alert patients before symptoms of heart failure occur. The purpose of the study is to determine if an implantable device, smaller than a smartphone, can effectively monitor the pressure in the left atrium of the heart, and manage the patient’s medications to reduce episodes of heart failure.
Contact: Kathleen Barackman, clinical research coordinator for Sentara Cardiovascular Research Institute, (757) 388-3876 or KMBARACK@sentara.com

Atrial Fibrillation
WILLIAMSBURG & HAMPTON ROADS
Ablation is a procedure used to treat abnormal heart rhythms (arrhythmias). The purpose of this study is to determine the safety and effectiveness of the CardioFocus Endoscopic Ablation System with Adaptive Contact (HeartLight) in the treatment of atrial fibrillation by creating electrical isolation of the pulmonary veins. The type of arrhythmia and the presence of other heart disease will determine whether ablation can be performed surgically or non-surgically.
Contact: Linette Klevan, clinical research coordinator for Sentara Cardiovascular Research Institute, (757) 388-2425 or LRKLEVAN@sentara.com

Breast Cancer
RICHMOND
This trial is testing whether magnesium supplements diminish hot flashes in women with breast cancer. Severe hot flashes can lead to discomfort, altered sleep and poor quality of life. This is a national phase III clinical trial being led by VCU Massey Cancer Center and the Mayo Clinic.
Contact: Gwendolyn Parker, Massey Cancer Center, (804)828-5090

Cholesterol    
RICHMOND
Six studies evaluating the effectiveness of adding different medications to statins to lower LDL (bad) cholesterol are being investigated. Participants must have diabetes, heart disease or high triglycerides between 500 and 2,000.
Contact: Dr. John A. Hoekstra, medical director of National Clinical Research—Richmond, Inc., (804) 755-2300

Diabetes 
NEWPORT NEWS
Do you have diabetes and a non-healing ulcer wound on your foot? Bon Secours Mary Immaculate Wound Care Center is enrolling patients in a clinical trial for the treatment of chronic diabetic wounds that will compare two active biologic wound care products (Dermagraft and TheraSkin). Wounds must have persisted for at least four weeks after traditional wound care.
Contact: Mary Immaculate Wound Care Center, (757) 886-6381

WILLIAMSBURG &NEWPORT NEWS
Two studies are evaluating a new formulation of Insulin Glargine and Lantus in patients with Type 2 diabetes. There are nine study visits during the 12-month trial duration. One arm of the trial is for patients taking mealtime insulin, another is for people taking oral antihyperglycemic medication. Must be 18 years of age.
Contact: Gina Cavanaugh, director of clinical research for the Center for Excellence in Aging and Geriatric Health, (757) 220-4751
Epilepsy    
WILLIAMSBURG & HAMPTON ROADS
This study examines the safety and effectiveness of a medication (USL261) administered through the nose for the outpatient treatment of seizure clusters.
Contact: Samantha Russell, research coordinator, (757)388-6124 or sjrussel@sentara.com

Flu Prevention
WILLIAMSBURG
If you are 65 or older, participate in a seasonal flu study to test if there is greater benefit from the high dose vaccine versus the regular dose vaccine. The purpose of the study is to evaluate the ongoing effectiveness of the seasonal influenza vaccine. The Williamsburg site is the only one approved locally, but compensation for travel is provided.
Contact: Gina Cavanaugh, director of clinical research for the Center for Excellence in Aging and Geriatric Health, (757) 220-4751

Gout    
RICHMOND
The purpose of this study is to determine if the current standard of care for gout can be improved with additional treatment. Participants must have uncontrolled gout (whether on or off therapy), have an average of two or more attacks per year and consume less than 14 alcoholic beverages per week. Adults up to age 85 may be enrolled.
Contact: Dr. John A. Hoekstra, medical director of National Clinical Research—Richmond, Inc., (804) 755-2300

Heart Disease / Heart Attack   
WILLIAMSBURG & HAMPTON ROADS
The purpose of the“AngelMed for Early Recognition and Treatment of STEMI” (ALERTS) study is to determine if a small implanted device, about the size of a silver dollar, can effectively monitor the heart around the clock for changes that might indicate it is not getting enough oxygen.
Contact: Tina Calayo, clinical research coordinator for Sentara Cardiovascular Research Institute, (757) 388-1568 or cawolszc@sentara.com

Ischemic Stroke              
NORFOLK
A Phase 1/Phase 2 Study of “Dalfampridine 10mg Extended Release Tablet in Subjects With Chronic Deficits After Ischemic Stroke” is investigating the safety of dalfampridine and its effect on sensory-motor abilities in people who have had a stroke. There are 18 sites  planned for this study in the United States.  Contact: Pam Hollsten of Sentara Neurology Specialists, (757) 388-6134 or pahollst@sentara.com

Lupus – SLE
WILLIAMSBURG & NEWPORT NEWS
This study is evaluating the safety and side effects of two injectable doses of LY2127399 versus placebo in patients with systemic lupus erythematosus (SLE). Participation involves 16 study visits during the 12-month trial duration with the option of continuing in an open label extension after completion of the study. Adults over 18 years old are eligible.
Contact: Gina Cavanaugh, director of clinical research for the Center for Excellence in Aging and Geriatric Health, (757) 220-4751

Rheumatoid Arthritis                
WILLIAMSBURG & NEWPORT NEWS
This study is evaluating the safety and side effects of two doses of MRC375 versus placebo in patients with moderate to severe rheumatoid arthritis. Participation involves eight study visits during the six-month trial duration. If the patient is currently taking a biologic or DMARD RA therapy, a washout period will be required. Other stable RA therapies would continue during the study. Adults over 18 years old are eligible.
Contact: Gina Cavanaugh, director of clinical research for the Center for Excellence in Aging and Geriatric Health, (757) 220-4751

Severe Depression           
RICHMOND
Deep brain stimulation (DBS) currently treats movement disorders and Parkinson’s disease, but as part of a new study at Virginia Commonwealth University, it will be evaluated for people with severe depression. Patients diagnosed with unipolar major depressive disorder, excluding bipolar disorder, who have failed at least four treatment options in their current episode, are eligible. In this study, stimulation will be delivered to an area of the brain believed to function differently in people with major depression.
Contact: Megan Edwards, study coordinator, (804) 828-4570 or mcedwards@vcu.edu

——

10 Trials to Watch
Here are 10 clinical trials currently in progress to keep an eye on, and their identifier number so you can search online for more information.

1. Cancer care delivery
The “Assessing the Patient Experience in Cancer Care” study aims to find out how physicians address issues such as symptom control and side effects—things perhaps swept aside during the rigorous treatment process. Patient and physician interactions are observed for several months.  http://clinicaltrials.gov/ct2/show/NCT01621295

2. Not a CPAP fan?
Sleep apnea diagnoses have skyrocketed recently, and the CPAP machine is the most common treatment option. However, low patient compliance rates indicate that discomfort and noise level prevent people from using them every night. A study in the United Kingdom aims to measure whether poor adherence makes cardiovascular risks worse.  http://clinicaltrials.gov/ct2/show/NCT01619748

3. Laser away that scar?
It may seem counter-intuitive to use a laser on a burn, but there is evidence that the use of laser therapy can decrease scar formation. Dermatologists have been testing this theory, and this Canadian clinical trial hopes to provide further evidence that fractional vascular lasers decrease the appearance of burn scars.  http://clinicaltrials.gov/ct2/show/NCT01619917

4. Mouthwash that prevents oral cancer
A mouthwash that prevents oral cancer sounds promising. Researchers at Ohio State University have found that a gel made from anthocyanins, powerful antioxidants, suppresses the genes that allow oral cancer to grow. The research team is looking at how this gel would prevent and treat oral lesions.                             www.cancer.osu.edu

5. For anyone who wants to help fight cancer
The Day and Night Study wants to explore the relationship between long-term cancer survival and diet, daytime activities and sleep habits. This study examines the quality of life among Stage 1 and 2 breast, prostate, colorectal and lung cancer survivors, but a control group of people without cancer is also sought.  http://www.epidemiology.vcu.edu/research/grants.html

6.  Attacking allergic asthma
The GLASGOW study in the UK aims to help categorize types of asthma using blood tests that may make treatment more targeted based on a more precise diagnosis. This may reveal more information about the role of immunoglobulin E, an antibody present in the blood of allergic asthma patients.  http://clinicaltrials.gov/ct2/show/NCT01618318

7. Alternatives in the emergency room
Evidence supports acupuncture for pain relief. This clinical trial, headed in Tunisia, is testing whether acupuncture might be used in emergency rooms to help control pain.  http://clinicaltrials.gov/ct2/show/NCT01622959

8. Chasing circulating tumor cells
A new technology is under investigation to detect circulating tumor cells in a patient’s bloodstream, and could help patients avoid a liver biopsy. Watching circulating tumor cells in the blood could lead to better screening tests. This technology is also being investigated for use in prostate cancer patients.  http://clinicaltrials.gov/ct2/show/NCT01427322

9. Comparing ankle options
Two primary treatment options exist for ankle arthritis: ankle fusion and ankle replacement. This study, by the National Institutes of Health, will directly compare the two procedures, measuring pain, physical function, ankle function and patient satisfaction over a two-year period, so patients can be aware of alternatives.  http://clinicaltrials.gov/ct2/show/NCT01620541

10. Fighting acne: How much is too much?
This study by Galderma will be of interest those struggling to control acne; the study enrolls up to age 35. The trial has several groups testing different dosages of an already-approved acne cream for effectiveness. It will record all of the side effects experienced by participants to determine the most effective dose.  http://clinicaltrials.gov/ct2/show/NCT01616654

 

EDITOR’S NOTE (October 2012):

Here is a list of clinical trials happening at Health Research of Hampton Roads:

Athletes Foot

High Triglycerides

Constipation

COPD

Birth Control

Asthma

 Learn more information at http://hrhr-inc.com