After three clinical trials, the side effects are worth it

I’ve been living with HER2-positive metastatic breast cancer for slightly over 5 years, after an early-stage diagnosis 10 years ago. Due to the fact that I live in a suburban part of Virginia that does not have a major cancer center, I have been primarily treated by a community oncologist. In the past 5 years, I have been on six lines of treatment, three of which were clinical trials. As you can imagine with so many treatments in a short period of time, I have experienced many varied side effects, such as peripheral neuropathy, that are persistent and require continual treatment. But, medical side effects are just the beginning when it comes to the effects cancer and treatments have had on me and my life. The non-medical ones are the ones I find both harder to treat, yet more important to treat.

I am a huge believer in clinical trials and not as a last resort. No doubt, they have extended my life. Because of this I would like to talk about the side effects (the non-medical ones) I have experienced from participating in a clinical trial. I strongly encourage patients to ask their oncology team about clinical trials from the beginning of treatment and do their own research so they can be their own strongest advocate. My experience has been that the standard of care treatments will always be available and using these medicines first can exclude you from clinical trials, especially phase III trials with control arms. This means starting clinical trials early makes more treatment options available to you.

When searching for clinical trials, I look for phase II trials, because usually there is not a control arm and participants are guaranteed to get the investigational drug — the medicine researchers are studying. However, I do not rule out phase III trials, I have been on two and was fortunate to receive the investigational drug. In these cases, the control arm was standard of care versus investigational drug.

Time:

As metastatic cancer patients we are resigned to cancer care taking much of our time, so much so that many of us, myself included, have retired or given up activities we previously enjoyed. Participating in a clinical trial takes use of your time to another level. As a trial participant you consent to have extra tests as the investigators and drug sponsors are tracking previously observed side effects and scanning you far more frequently. On all three trials I had additional blood work, an EKG every 3 weeks, a CT scan every 6 weeks, and an echocardiogram and an ophthalmic appointment every 12 weeks. While the clinical trial research personnel help you remember and schedule these appointments, you are the one who has to make the time, get yourself there, wait, and then have the test. Waiting alone is a time suck. I have spent hundreds of hours in waiting rooms for these the required appointments. Hours I would have much rather spent playing tennis with friends, spending time with my granddaughter, or teaching high school kids math.

Anxiety:

We are all familiar with “scanxiety.” I start to feel anxious as soon as the scan is scheduled, which is usually 3 weeks before I get the results. I feel alone, sad, angry, frustrated, worried, and completely not in control of my life. For me, it increased with a clinical trial. Required scanning every 6 weeks instead of every 3 to 4 months tremendously increased my anxiety. So much depends on the results — progression means no more trial. The other tests were also anxiety producing because, like most of us, I don’t like poor test results. I worry that poor results on them could remove me from the trial as is the case in some trials.

Money:

To participate in the phase II trial, I traveled from Virginia to New York City every 3 weeks for 2 years. The round trip is about 750 miles, which I made with a combination of car and train travel. The trial paid $100 per cycle for expenses, which was a drop in the bucket when you add lodging, meals, and taxis to the travel cost. I was lucky to make it work, but many patients, especially those not working, cannot afford this financial outlay. However, if you are fortunate to live near a major cancer center it would not nearly be this costly. This was the only way I could get this life-extending medicine, so that was the choice I made, and I am glad I did.

Now the positive side effects

You have a team! In a clinical trial you are closely monitored by the research and oncology teams. The focus is exclusively on your and the drug’s success. I have never felt so cared for or my cancer so well monitored.

The medicine being studied is paid for by the trial sponsor and my health insurance picked up all the other costs of my treatment. I recognize this might not be the case for every trial participant.

You are most likely moving a drug forward that will benefit thousands of patients like yourself. One of the drugs received Food and Drug Administration approval right after I left the trial, and I know at least seven people personally who are currently on it. Another of the medicines earned FDA approval while I was in the trial. I am proud to have contributed to these approvals and more importantly what it is doing for others. My trial participation is part of my advocacy work.

Because I was in New York City so frequently, I was able to take advantage of the city, its museums, Broadway, shopping, and restaurants. Might as well make lemonade out of the lemons that had been thrown at me, right?

And who would have thought COVID-19 has had a positive side effect on cancer? In September I participated in a virtual metastatic breast cancer conference where it was discussed that pharmaceutical sponsors have allowed some trials to become decentralized, meaning extensive required tests and scans were done locally. The hope is that this experiment with decentralization will be successful and more trials will be launched in this manner. Based on my experience, this would make participating in clinical trials a lot easier for people who do not live close to major cancer centers like myself.

I am not going to say it hasn’t been hard and there weren’t days I wished I wasn’t on them, but hands down the pros outweigh the cons for me when it comes to clinical trial participation. I hope laying them out helps address concerns I know many have.

Lori Burwell, 64, was diagnosed with metastatic breast cancer in in May 2015. She has participated in multiple clinical trials and is part of LBBC’s Hear My Voice Advocacy Program class of 2020. She has two adult children and is awaiting her second grandchild. Lori plays tennis twice a week, and says exercise has helped her cope with side effects of treatment. She lives in Virginia with her husband.