Clinical Trials: Tomorrow’s Treatment Today

Bon Secours’ William J. Irvin, MD, discusses clinical trials for oncology. He describes them as “tomorrow’s treatment today.” Clinical trials give patients access to the newest and best treatments for cancer. Click here to find cancer clinical trials in your community.

Value of Community Based Cancer Care

Community based care brings great value to cancer patients.  Being “treated by the people that they already know, they sleep in their own bed, it’s an ability to take what was only available at the medical centers in the past right to their homes.”  In this video, researchers in the NCI Community Oncology Research Program (NCORP) discuss how network makes it easier for people from diverse settings to enroll in cancer clinical trials closer to home.

Source: National Cancer Institute 

Clinical trials at CarolinaEast offer cancer patients best care close to home

From New Bern Sun Journal
Posted Sep 2, 2020

Margaret Pardini of Havelock had lung cancer surgery Oct. 30 at the SECU Comprehensive Cancer Center at CarolinaEast Medical Center.

As with most cancer patients preparing to undergo chemotherapy, Pardini was concerned about its common side effects – nausea and vomiting. A widow, Pardini also was concerned about the financial burden she might face from taking an expensive drug routinely given to combat those side effects.

“Granted, I do have insurance, but I don’t know how far the insurance would have paid and how I would have survived having to pay for an expensive drug,” she said.

Because CarolinaEast is part of the Southeast Clinical Research Consortium, supported by the National Cancer Institute, Pardini was able to enroll in a clinical trial at the hospital before starting chemo in January.

The trial tests the effectiveness of Olanzapine, an FDA-approved anti-psychotic drug, with or without the more expensive standard-of-care drug fosaprepitant in preventing nausea and vomiting in patients receiving chemotherapy, said Lynn Harrison, clinical research nurse at the cancer center.

“One of the major fears of patients when they are about to get chemotherapy is that they’re going to have nausea and vomiting,” Harrison said. “It is considered by patients to be a severe side effect.”

The study is gathering further evidence that Olanzapine should be recommended for use to help with chemotherapy-induced nausea and vomiting, she said.

Study participants are divided into two groups. One group receives Olanzapine and three other drugs, including fosaprepitant. The second group receives the same drugs except for the fosaprepitant, which is replaced with a placebo, a substance with no effects.

Pardini later found out she was in the group that received Olanzapine and the other drugs, but a placebo instead of fosaprepitant.

She said she was a little afraid of receiving chemo because everybody told her she would get sick.

“I never got sick, which was great on my part,” Pardini said. “I had no ill effects from being in this study at all.”

Harrison said just because Pardini’s experience during chemotherapy was side-effect free, researchers can’t generalize that’s going to be the result of the study overall.

“That’s just this patient’s experience,” she said.

Harrison said Pardini’s participation in the trial was double-blind during the first cycle of chemotherapy.

“I don’t know what she’s getting, the doctor doesn’t know what she’s getting, and the patient doesn’t know what she’s getting,” Harrison said, referring to the anti-nausea drugs. “In her case, she got placebo.”

If the patients have no nausea and vomiting, and they want to continue with the study for the remainder of their chemotherapy, they let the research staff know, she said.

“We unblind everyone so that we know what the patient got and then we continue to let them receive exactly what they got in the first cycle,” Harrison said. “Then we continue to collect data about their side effects, nausea and vomiting, and whether they had to take any relief medication for breaks from nausea.”

Pardini said she had a great experience at the cancer center and in the trial.

“I couldn’t ask for better care than what I got,” she said. “They kept me informed. They were always there for me.”

Her fourth and final cycle of chemo was March 10, but Pardini’s participation in the trial continued for a month afterward so she could be monitored for side effects and adverse events, Harrison said. Pardini completed the study April 10.

So far, the hospital has had five patients complete the phase III randomized, double-blind, placebo-controlled trial that was opened in 2018, Harrison said.

“In the cancer center we have about 10 interventional trials – sometimes called treatment trials – open,” she said.

Including other trials, such as those that look at the way the center delivers cancer care, the hospital has a total of about 13 studies currently open.

Harrison said she joined CarolinaEast in 2016 because the cancer center needed a research program at the community level to offer its patients opportunities to participate in clinical trials.

Clinical trials are now considered the best care of a patient who has cancer, Harrison said.

“There’s a misconception that trials are only to be offered to patients who don’t have any other alternatives, or they’ve exhausted all other therapies,” she said. “But that’s not the case anymore. Trials should be looked at as treatment options. We have so many different types of trials that they can sometimes be used from the point of diagnosis.”

Trials are generally covered by health insurances and Medicare, Harrison said. Patients still should get prior authorization before participating, she said.

Because CarolinaEast is a member of the Southeast Clinical Research Consortium, funded by the National Cancer Institute, the hospital has access to multiple research organizations that write research protocols and offer those at the community level, Harrison said.

The trial Pardini participated in is a National Cancer Institute-supported trial and the research base for the trial is the Alliance for Clinical Trials in Oncology, Harrison said.

“What we’re doing here is participating in practice-changing research,” she said. “It’s really exciting for us to be able to offer this to our patients locally at home instead of them having to travel to UNC or Duke to get a therapy that’s cutting edge.”

Cancer Care Delivery Research

Cancer Care Delivery Research (CCDR) is a multidisciplinary science that seeks to improve clinical outcomes and patient well-being by intervening on patient, clinician, and organizational factors that influence care delivery.

CCDR generates evidence that can be used to improve clinical practice patterns as well as develop and test promising interventions within the health care delivery system. It also supports development of new and generalizable knowledge about the effectiveness, acceptability, cost, optimal delivery mode, and causal mechanisms that influence outcomes and affect the value of cancer care across diverse settings and populations. The goal of CCDR is evidence-based practice transformation.

Integrating CCDR within NCORP provides the ability to collect primary data on current delivery practices and initiate interventions in non-academic settings; look across a mix of practice models and heterogeneous populations; and follow patients from time of diagnosis through treatment and survivorship.

In this video, Philip J. Stella, M.D., principal investigator of the Michigan Cancer Research Consortium NCI Community Oncology Research Program (NCORP) describes how cancer care delivery research works to find the best way to care for patients.


Some Questions to Ask if You’re Offered a Clinical Trial

Dr and patient discuss cancer clinical trialIf you are offered a clinical trial, feel free to ask any questions or bring up any issues concerning the trial at any time. The following suggestions may give you some ideas as you think about your own questions.

The study

  • What is the purpose of the study?
  • Why do researchers think the approach may be effective?
  • Who will fund the study?
  • Who has reviewed and approved the study?
  • How are study results and safety of participants being checked?
  • How long will the study last?
  • What will my responsibilities be if I participate?

Possible risks and benefits

  • What are my possible short-term benefits?
  • What are my possible long-term benefits?
  • What are my short-term risks, such as side effects?
  • What are my possible long-term risks?
  • What other options do people with my disease have?
  • How do the possible risks and benefits of this trial compare with those options?

Participation and care

  • What kinds of therapies, procedures and /or tests will I have during the trial?
  • Will they hurt, and if so, for how long?
  • How do the tests in the study compare with those I would have outside of the trial?
  • Will I be able to take my regular medications while in the clinical trial?
  • Where will I have my medical care?
  • Who will be in charge of my care?

Personal issues

  • How could being in this study affect my daily life?
  • Can I talk to other people in the study?

Cost issues

  • Will I have to pay for any part of the trial such as tests or the study drug?
  • If so, what will the charges likely be?
  • What is my health insurance likely to cover?
  • Who can help answer any questions from my insurance company or health plan?
  • Will there be any travel or child care costs that I need to consider while I am in the trial?

Tips for asking your doctor about trials

  • Consider taking a family member or friend along, for support and for help in asking questions or recording answers.
  • Plan ahead what to ask — but don’t hesitate to ask any new questions you think of while you’re there.
  • Write down your questions in advance, to make sure you remember to ask them all.
  • Write down the answers, so that you can review them whenever you want.
  • Ask about bringing a tape recorder to make a taped record of what’s said (even if you write down answers).