Pelotonia Supports Clinical Research at the OSUCCC – James 

Clinical research is research that studies people. It includes clinical trials, which investigate the safety and effectiveness of new therapies, and studies that make observations of people to better understand and ultimately solve a medical problem. In this way, clinical research improves cancer care. Here are two examples of clinical research at the OSUCCC – James that are supported by Pelotonia funds.

To learn more about clinical studies available at Ohio State, call The James Line at 800-293-5066 or visit

Learning How Women With Breast Cancer Make a Critical Decision

A growing number of women who develop cancer in one breast are choosing to have the unaffected breast removed also. The procedure is called contralateral prophylactic mastectomy (CPM). It is typically appropriate for women at high risk for breast cancer, such as those with a strong family history of the disease or with a mutation in a breast cancer gene.

But a rising number of women with sporadic (nonhereditary) breast cancer are also requesting it. Over the past decade, rates rose to 12 percent, up from 2 percent, among early-stage breast cancer patients, and to 33 percent among younger breast cancer patients. Women say they choose the procedure to reduce fears of developing cancer in the second breast and for greater control over appearance.

What is unclear is how well women understand the risks of CPM, which can include surgical complications, a longer recovery time, a more far-reaching altered body image, impaired sexual experiences and greater financial cost. It’s also unknown whether the procedure improves a woman’s quality of life or how it affects survival.

Clara Lee, MD, associate professor of Plastic Surgery and a member of the OSUCCC – James Cancer Control Program, is leading a Pelotonia-funded clinical study to better understand how women choose to have the procedure.

“We want to understand how patients make decisions about CPM, and how patients and providers communicate about the procedure,” Lee says. “Patients appear to be the ones who initiate the discussion about CPM, and healthcare providers seem somewhat reluctant to discuss or offer it. But we don’t really know what patients and providers are actually saying to each other.”

Lee and her colleagues are studying how women with early-stage breast cancer make treatment decisions and how discussions they have with their oncologists affect their decision. They are also examining the women’s knowledge about CPM, their treatment preferences and their quality-of-life expectations.

The two-year study involves 77 women undergoing treatment for breast cancer. The researchers are developing and testing a smartphone application that study participants are using to record the conversations they have with their oncologists. The researchers will evaluate those discussions for informed decision-making and for patient and provider interaction.

“Past studies like this were done by having a researcher record the conversations,” Lee says. “Empowering patients to do the recordings themselves enables us to do two things—to include patients from all kinds of places, not just academic centers, and to include a wider range of oncology specialists. Those are both critical things for doing more-valid research.”

Lee’s collaborators include specialists in surgical oncology, radiation oncology and bioinformatics, and faculty in integrated systems engineering in the College of Engineering, in the College of Public Health and in the School of Communication.

Ultimately, Lee and her colleagues believe their findings will help clinicians better assist patients in making an informed decision about their care.

Improving an Alternative Treatment for Early Lung Cancer

Lung cancer is the leading cause of cancer-related deaths in the United States and worldwide. Of the more than 200,000 new lung cancer cases diagnosed each year in this country, about 85 percent are a type called non-small cell lung cancers (NSCLCs).

About 15 percent of NSCLC cases are diagnosed at an early stage. Surgery is the best treatment option for these early cases, and 60-70 percent of patients are alive after five years. Sometimes, though, surgery isn’t an option for these patients, such as those who are medically frail. These patients are typically treated with radiation therapy, but their survival rates tend to be lower than for those treated with surgery. This is likely due to preexisting medical conditions that limit their life expectancy.

The problem is that the dose of radiation delivered to many lung tumors must be reduced to protect nearby vital structures, such as the heart and aorta. “This results in lower rates of tumor control and poorer clinical outcomes,” says Terence Williams, MD, PhD, associate professor of Radiation Oncology.

Williams and Nicholas Denko, PhD, MD, professor of Radiation Oncology, have designed a Pelotonia-funded phase I clinical trial to address the problem. They are testing the use of a drug that makes lung tumors more sensitive to lower doses of radiation. If it works as planned, it will enable lower-dose radiation to kill more tumor cells. The researchers call it “biologic dose-escalation.”

“We are using a drug to make the tumor more sensitive to radiation as a novel way to improve tumor control in patients who cannot have full-dose treatment,” Williams says.

The drug Williams and Denko are studying is an FDA-approved agent called papaverine. It’s a muscle relaxant that has been used for more than 100 years and has an excellent safety profile. Earlier laboratory studies by Denko had shown that papaverine reduces oxygen consumption in cancer cells, making it more available in the tumor microenvironment. Low oxygen levels are an established mechanism by which radiation works less effectively.

The researchers believe that the drug will help overcome a form of resistance to radiation that occurs in solid tumors. It happens because solid tumors have poor blood circulation, which leaves many areas of a tumor poorly oxygenated, or “hypoxic,” and low-oxygen levels protect cancer cells from being killed by radiation. In fact, it can take a radiation dose that is two to three times higher to kill hypoxic cancer cells compared with fully oxygenated cancer cells.

“Based on our preclinical studies of papaverine, we proposed a phase I trial in patients with NSCLC to test the safety of the drug in combination with radiation,” Williams says. “We believe papaverine could dramatically improve tumor control after radiation, with minimal damage to normal tissue. Thanks to Pelotonia, we can test our hypothesis.”

Williams’ and Denko’s study could have broad implications. “If we can reverse the effects of tumor-induced hypoxia and improve the success of radiotherapy in these NSCLC patients,” Williams says, “it might also apply to many other tumor types.”

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