toh

Four years after beginning her trial, Beth Ciavaglia juggles a busy schedule as a mother of two, the executive director of a local charity and a patient advocate in cancer research.

Clinical trials are a cornerstone of improving health care for people with cancer. A clinical trial is a research study where patients volunteer to test treatments, such as medications and medical procedures, so researchers can learn how effective they are in treating illnesses and improving quality of life.

While most cancer clinical trials focus on evaluating new treatments, a team of researchers at The Ottawa Hospital is taking a very different approach.

The REthinking Clinical Trials (REaCT) program focuses on comparing existing standard treatments to find out which ones are best for patients with cancer. This means that findings from REaCT trials can help a wide range of patients almost immediately — and not years down the line.

Another thing that sets REaCT apart: It’s truly patient-centred. REaCT partners with patients and their loved ones every step of the way, from coming up with ideas to designing studies to sharing results. And unlike traditional trials, which are highly selective in the patients who can join and very expensive to run, REaCT trials are pragmatic and low-cost, which means they include a wide variety of patients, who do not require additional visits outside of their routine care. The more patients who enroll, the more that can be learned, which leads to better treatments and practices.

“Our goal is to do trials that matter to patients,” says Dr. Mark Clemons, Scientist, Medical Oncologist and one of the founders of REaCT. “Patients tell us what’s wrong, and we design a trial to answer those questions.”

Since launching in 2014, REaCT has become the world’s largest pragmatic cancer clinical trials program, with more than 5,000 patients enrolled in trials at health-care centres across Canada. REaCT has influenced medical practice both in Canada and internationally.

Beth Ciavaglia is one of REaCT’s biggest patient champions and just wrapped up a trial that may someday change the lives of people with breast cancer around the world.

Life after treatment: Beth’s story

Beth was diagnosed with stage 3 breast cancer just two weeks shy of her 40^th birthday. After finishing her chemotherapy under the care of Dr. Clemons, Beth joined a REaCT trial focused on a drug called zoledronate, which reduces the risk of breast cancer coming back. The standard protocol is for patients to receive one dose every six months over three years, but Beth would receive just a single, one-time dose.

With this world-first trial, researchers wanted to find out if the one dose was just as effective as the usual seven. This is because although cancer drugs can be very effective, they can also lead to debilitating side effects that significantly reduce quality of life, such as aches, pains and flu-like symptoms.

“There are excellent drugs out on the market, but the standard dosage is always based on the maximum that the patient can tolerate,” explains Dr. Marie-France Savard, Clinician Investigator with REaCT and Medical Oncologist at The Ottawa Hospital. “For some of these drugs, we know that a lower dose can do the same thing but with less toxicity.”

This resonated with Beth. “At my request, I had actually ended my chemotherapy one round early. I had gotten to a point where it was just too much,” she recalls. “Dr. Clemons supported my decision to stop. And despite deviating from the standard treatment, surgery later found that I had no cancer left at all.”

Though Beth experienced the standard side effects of zoledronate, she is grateful she only had to take the one dose. “I don’t know that I would have been able to complete all seven,” she says.

And the trial suggests that a single dose is all that patients need. “The results were absolutely the same, except with less toxicity,” reports Dr. Clemons.

Four years after starting the trial, Beth has had no recurrence of her cancer and no long-term side effects from her zoledronate treatment. She just finished her final check-in with the REaCT team this fall. “I’m officially done!” announces Beth with joy.

Beth is now a patient research partner with the Terry Fox Research Institute and the Canadian Institutes of Health Research, providing feedback to researchers on what’s important to patients. At the top of that list is quality of life.

“I feel that there is this societal sense that after you’re done treatment, you’re good. But there is this fallout from treatment that we have to live with for the rest of our lives,” explains the mother of two. “You want that life after to be as close as possible to what it was before. And that’s why REaCT is so important.”

The medical community is reacting

REaCT is showing the world a lot about how to improve the lives of patients with cancer.

Another REaCT breast cancer study has changed the standard of care for breast cancer patients worldwide. Focused on a drug called filgrastim, which is commonly used to prevent infections, the trial found that five doses are just as good as the usual seven to ten.

And because these drugs are often very expensive, REaCT has shown that by optimizing dosing, the health-care system can reap substantial savings in drug acquisition costs, blood tests and more.

Looking to the future, Dr. Clemons and his team plan to expand the portfolio of cancers treated under the program.

“Our data is out there, and the world knows about it. But what we do not want to do is become complacent and sit on our laurels,” says Dr. Clemons. “We must continue doing research that improves the outcomes of our patients so that they can live the lives they want to live.”

For a deeper dive into how REaCT does clinical trials differently, and to learn about active trials, please visit REaCT’s website.

You might also like…