From New Bern Sun Journal
By Jim Ware, Sun Journal Correspondent
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.”