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Cutting-Edge Clinical Trials Close to Home

 

Three open trials in dementia, diabetes and lung cancer may benefit your patients.

Clinical trials provide patients with access to new treatments, additional care and the satisfaction of helping to advance medicine for others.  

WellSpan Health has more than 130 open clinical trials, making world-class research accessible to patients in their local community. Among these open trials are three studies on dementia prevention, diabetic neuropathy and lung cancer screening. Here’s what they’re testing, how patients benefit and who’s eligible.

PREVENTABLE Trial: Dementia Prevention

What it’s testing: Can taking a daily statin pill help prevent dementia, heart disease and other conditions in adults older than 75? 

PREVENTABLE (PRagmatic EValuation of evENTs And Benefits of Lipid-lowering in oldEr adults) is the first trial asking whether a statin (Lipitor) can reduce dementia and cardiovascular disease in this age group.

How patients may benefit from the trial: “Patients have a 50-50 chance of getting a safe and easy intervention that may prevent dementia,” says Rahul Kashyap, MD, MBBS, MBA, FCCM, medical director for research at WellSpan Health. PREVENTABLE is a randomized controlled trial and each participant will be randomly given Lipitor or placebo pills.

Many participants won’t have to leave their home for the trial. They can get screened for eligibility over the phone and receive pills in the mail. Participants also appreciate annual follow-up evaluations (for up to 5 years) that include cognitive testing from trial clinicians, Dr. Kashyap says.

Who can participate in PREVENTABLE:

  • Healthy adults 75 and older
  • Must be living independently
  • Must not have vision or hearing impairment
  • Must not have dementia or a history of heart or vascular disease
  • Must not have taken a statin in the last 12 months

SENZA-PDN Trial: Relief From Diabetic Neuropathy

What it’s testing: Can Senza, a spinal cord stimulation (SCS) implant, help patients with painful diabetic neuropathy (PDN) in their legs?

An earlier clinical trial of the implant found that 86% of patients had at least 50% pain reduction one year after getting the implant. As a result, the U.S. Food and Drug Administration approved Senza in 2022. Now, researchers at WellSpan Health and other sites are asking whether it can achieve this level and duration of pain reduction in a larger, real-world study.

How patients may benefit from the trial: Although patients can receive Senza without joining the trial, those who participate get more prompt care thanks to the trial’s additional resources.

About 25% of patients need the stimulator adjusted or reset at least once to optimize pain relief or because the device shifts. “While regular appointments may take weeks, research nurses can often help within a day,” says Rajat Mathur, MD, a pain specialist who is leading the study at WellSpan Health.

Medication adjustments can also happen quickly in the trial because patients get blood work and pain assessments 3, 6 and 12 months after getting the stimulator, Dr. Mathur says. Patients outside the trial may only get blood work every 12 months.

Who can participate in Senza-PDN:

  • Patients with moderate to severe PDN in their legs
  • Patients who are not getting pain relief from conventional medications or cannot tolerate these treatments

PROACT-LUNG Trial: Blood Test for Lung Cancer

What it’s testing: Can a blood test detect lung cancer and someday take the place of low-dose CT (LDCT) scans for lung cancer screening?

Although LDCT detects lung cancer in early stages, fewer than 10% of eligible people get screening. “We need new screening methods that don’t require patients to travel far distances or be exposed to radiation, which many are afraid of,” says Amit B. Shah, MD, radiation oncologist who is leading the WellSpan Health site of PROACT-LUNG, a multisite observational study.

How patients may benefit from the trial: The study aims to determine whether the blood test matches LDCT findings and predicts who will develop lung cancer in the next 2 years.

“Participants in this trial could shape a brighter future for lung cancer detection,” Dr. Shah says.

Who can participate in PROACT-LUNG:

  • Anyone recommended for low-dose CT lung cancer screening
  • Must be willing to have blood draw and complete questionnaire on day of, or within 45 days of, LDCT

Support for Study Participants

Research participants at WellSpan Health stay with their local providers and have a dedicated coordinator who acts as their advocate throughout the research process. The coordinator helps them along the steps of the study, answers their questions and communicates with physicians to streamline the process and ensure patients feel supported.

Refer a Patient

Providers can email ezahos@wellspan.org or jmoore@wellspan.org to connect with our research staff and refer a patient for a trial.