Clinical Trials Offer Hope for Patients
- Brave and resilient actress Shannen Doherty, 52, launched a new podcast that will partly chronicle her metastatic breast cancer journey. She remains positive and has since explored clinical trials to aid her cancer journey and subsequent treatment.
- Clinical trials help doctors better understand cancer and discover more effective treatment methods. They also allow patients to try a treatment before it’s approved by the U.S. Food and Drug Administration (FDA), which can be life-changing.
- Despite the benefits of clinical trials, they also come with risks (like potential side effects that are not fully understood yet). People interested in participating in clinical trials must first talk with their doctor to see if they would be a good fit.
- In 2015, Doherty was first diagnosed with breast cancer. It went into remission in 2017 but returned as stage 4 cancer in 2019. Her breast cancer spread to her brain, causing her to undergo surgery to remove a tumor in her brain. Since brain surgery, Doherty’s recovery appears to be going well as social media posts by the beloved actress show her in good spirits, surrounded by loved ones.
- For help finding a clinical trial that’s right for you, try our easy-to-use Clinical Trial Finder.
In an extraordinary new interview, Actress Shannen Doherty, 52, talks about her mortality and will to live as she deals with advanced breast cancer. The actress, who rose to fame on the hit show “Beverly Hills 90210” is launching a new podcast called “Let’s Be Clear with Shannen Doherty,” which chronicles part of her professional and personal life. She says a huge chunk of her content will revolve around her emotional cancer journey that has consumed her life since 2015. However, despite the challenges cancer has brought into her life, she says her greatest memory has yet to come.
“I’m not done with living. I’m not done with loving. I’m not done with creating. I’m not done with hopefully changing things for the better,” Doherty said in an interview with People Magazine.Read More
“People just assume that it means you can’t walk, you can’t eat, you can’t eat, you can’t work. They put you out to pasture at a very early age,” she said of some broad assumptions about cancer patients.
“We’re vibrant, and we have such a different outlook on life. We are people who want to work and, embrace life and keep moving forward…We’re the people who want to work the most, because we’re just so grateful for every second, every hour, every day we get to be here,” she continued.
Doherty revealed she’s exploring clinical trials with hopes of finding a new treatment to aid her on her metastatic breast cancer journey. To learn more about clinical trials for breast cancer, check out SurvivorNet’s Patient Pathfinder.
Helping Patients Understand the Value of Clinical Trials
Clinical Trials Offer Hope, but They’re Not for Everyone
Studies of new treatment options are called clinical trials, and they are an essential part of medicine for two reasons:
Clinical trials help doctors better understand cancer and discover more effective treatment methods.
They also allow patients to try a treatment before it’s approved by the U.S. Food and Drug Administration (FDA), which can be life-changing.
WATCH: Clinical Trials Help Find New Treatment Options
Dr. Beth Karlan is a gynecologic oncologist at UCLA Health. She says the goal with clinical trials is to advance cancer research to a point where the disease becomes akin to diabetes, where it becomes a manageable condition.
“Clinical trials hopefully can benefit you, but is also providing very, very vital information to the whole scientific community about the effectiveness of these treatments,” Dr. Karlan said.
“They can be lifesaving. In the last few years, we’ve seen many children and adults who have participated in trials and had miraculous results,” Dr. Karlan continued.
Understanding the Process Behind Clinical Trials
Within the U.S., all new drugs must go through clinical trials before the FDA approves them. Although the rewards of clinical trials can be great, they also come with risks. Talking to your doctor about this before enrolling in a trial is important. Some risks to consider include:
The risk of harm and side effects due to experimental treatments
Researchers may be unaware of some potential side effects of experimental treatments
The treatment may not work for you, even if it has worked for others
Before you enroll in a trial, you must be allowed to read the consent documents thoroughly and to ask any questions you may have. The documents will likely contain the following:
- The purpose of the research
- Any risks and benefits expected from the research
- Information about procedures that may cause discomfort (like frequent blood tests)
- Any alternative procedures the patient might consider instead
- How the patient’s information will be kept private
- How long the study is expected to take
- A form confirming you are participating in research voluntarily
- Whether any compensation or additional medical care is available if some injury occurs
- The patient’s rights (like the right to stop research in the middle of the trial)
- Contacts for any patient questions
Patients are allowed to walk away at any time during the trial. Understanding your rights as a voluntary patient is important before you participate in a clinical trial, and understanding that the treatment may not work is also crucial.
Costs of Clinical Trials
Clinical trials may also have no extra cost for the participants, as the study’s sponsor may pay for the treatment and any additional care. Some sponsors even pay for travel to and from appointments or treatment centers. Patients should ask what will be paid for before signing up for a trial.
The Affordable Care Act also mandates that health insurance companies cover routine patient care costs while people are enrolled in clinical trials.
During the treatment of an experimental drug in a clinical trial, while some participants receive the real thing, others do not. These participants received a placebo.
The placebo is “an inactive substance or other intervention that looks the same and is given the same way as an active drug or treatment being tested. The effects of the active drug or other intervention are compared to the effects of the placebo,” as defined by the National Cancer Institute.
In some cancer clinical trials that are “randomized,” patients who enroll are randomly assigned to receive either a placebo or the new experimental drug being studied. If the clinical trial is “double-blinded,” neither the patients nor the doctors running the clinical trials know who’s in which group. This is an important part of a clinical trial design because it safeguards against bias and the possibility of skewed results.
It’s important to know that getting zero treatment isn’t usually the reality of the “placebo arm” anyway.
Instead, when patients with life-threatening cancers enroll in randomized clinical trials, the two groups are often broken into the new, experimental drug and a “control” group that receives the “standard-of-care” treatment.
Treatments considered standard of care are those that experts accept as the go-to treatment for specific cancers. Standard-of-care, in other words, is the most used treatment.
In many cases, it might involve a combination of chemotherapy, surgery, or radiation, but not always.
Do Clinical Trials Have Limits on Who Can Participate?
It’s important to remember that just because you’re willing to participate in a clinical trial doesn’t necessarily mean you will be able to join. These trials have specific criteria that patients need to meet to take part.
Ultimately, even though these trials can have incredible results and provide you with access to cutting-edge therapies, these are controlled experiments.
For each trial, there will be certain inclusion and exclusion criteria.
Sometimes, patients may be excluded from certain trials if their cancer has spread to their brain. If the metastases aren’t under control, the patient may be unable to participate because researchers are concerned that they won’t be able to complete the whole study.
“Because of the way the study needs to be done, not only for safety reasons but also for scientific reasons where we’re trying to actually answer a question, we have to set up criteria for who can participate in the trial, even though it makes it difficult to find the patients who are eligible,” Dr. Alana Welm from the Huntsman Cancer Institute Research South, previously explained to SurvivorNet.
“If we were to do a trial where we didn’t have certain inclusion or exclusion criteria, the result would not be interpretable,” Dr. Welm added.
How to Find a Clinical Trial
If you want to participate in a clinical trial, your first step should be to talk with your doctor. They can address many of your initial questions and help determine whether you would be a good participant.
Another crucial part of clinical trials is finding the right one for you. SurvirorNet has a resource to help with this called the Clinical Trial Finder.
Doherty’s Mighty Cancer Journey
Shannen Doherty’s initial breast cancer diagnosis arrived in 2015 after she discovered a lump in her breast. For treatment, she had hormone therapy, a single mastectomy (the removal of all breast tissue from one breast), chemotherapy, and radiation.
In 2017, she achieved remission status, but the disease returned two years later in 2019. This time around, her breast cancer was metastatic, or stage 4.
Having metastatic breast cancer means the cancer has spread, or metastasized, beyond the breasts to other parts of the body. It often spreads to the bones, liver, and lungs, but it can also spread to places like the brain.
With advanced disease, treatment aims to keep you as stable as possible, slow the tumor growth, and improve your quality of life.
Doherty’s cancer then spread, or metastasized, to her brain. As a result, she’s undergone both radiation and surgery in the form of a craniotomy to improve her prognosis.
As cancer treatments improve year over year, so does the number of people battling this form of cancer that spreads to the brain, says Dr. Michael Lim, who is the Chair of the Department of Neurosurgery and a board-certified neurosurgeon specializing in brain tumors at Stanford Medicine.
According to Dr. Kimberly Hoang, a board-certified neurosurgeon at Emory University School of Medicine, a craniotomy procedure like Doherty underwent earlier this year is “a procedure to cut out a tumor” on the brain that may be particularly useful “if the tumor is causing symptoms or if it’s large.”
Since undergoing brain surgery, Doherty has focused on enjoying precious time with loved ones as she continues battling stage 4 cancer.