Let’s Talk About Clinical Trial Washouts

A friend of mine — a fellow EGFR lung cancer survivor — passed away this week. Unfortunately, this is not an uncommon occurrence in the lung cancer community, but there is one heartbreaking similarity between my friend’s recent death and the death of another lung cancer friend a couple of months ago.

What’s a ‘washout’ period?

Both women were in a “washout” period, waiting for a clinical trial to begin that had already accepted them as patients. What is a washout period? According to the U.S. National Library of Medicine, a washout period is defined as “a period of time during a clinical study when a participant is taken off a study drug or other medication in order to eliminate the effects of the treatment.” So basically, it means a time when a lung cancer patient is not being actively treated for his or her cancer while waiting for a new treatment to begin.

Many lung cancer clinical trials require washout periods prior to starting the investigational medication. Don’t get me wrong, I understand why these washout periods are included — investigators want to know the impact of their new treatments independent of other influences that might affect the results. However, a balance is desperately needed to protect patients better. Depending on the trial and the type of medication that a patient is stopping, these washout periods can sometimes be weeks long. That’s a long time for someone with advanced lung cancer to be off medication!

No time to waste

It’s kind of a paradox — in order to qualify for a clinical trial, lung cancer patients need to be relatively healthy and able to withstand an experimental treatment. There are tons of inclusionary and exclusionary criteria that often weed out the sicker patients who have been on multiple lines of treatment or who have serious progression. However, once a patient qualifies for a trial, the washout period begins; this period without treatment prior to the trial start can lead to increased progression, sicker patients and even death.

What is the answer? Well, I think clinical trial designers need to take a closer look at the necessity for lengthy washout periods when writing clinical trials. I was discussing this topic with a fellow advocate friend of mine and I thought he had a really good point — washout periods would never happen in real life outside a trial!

Is this a barrier to trial participation?

Once drugs are FDA-approved, patients start new medications directly following previous treatments. They usually don’t wait weeks post-progression to change treatments after a new plan has been identified! For example, when I progressed in November 2016, I stopped taking Gilotrif one day and started taking Tagrisso the next day. This was possible since both drugs were already FDA-approved, but would likely not have been possible if Tagrisso was still in clinical trials.

I hear lots of discussion from medical professionals about the urgent need for increasing patient participation in lung cancer trials. I believe the necessity for lengthy washout periods should be carefully considered. Being part of a trial that requires a long washout period can be as much of a deterrent to patients as other barriers to clinical trial participation, such as time, travel and financial requirements.

This article represents the opinions, thoughts, and experiences of the author; none of this content has been paid for by any advertiser. The LungCancer.net team does not recommend or endorse any products or treatments discussed herein. Learn more about how we maintain editorial integrity here.

Comments

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  • penelope
    4 months ago

    Hello Ivy. I am also stage four with brain spread. I believe you changed from tarceva when spread to your brain. Is this coreect. I have had two gamma knife procedures. One when first diagnosed oct 2016 and another this past winter. Thank you for your response. Your sdvocy and your sharing with all of us. I am sorry about friend that passed. Especially sad as waiting on a trial

    Annie

  • penelope
    4 months ago

    Hello ivy. I am so sorry to hear about friend death. There has to be a better protective way to do these trials. I have been on tarceva fir two years in October. I have stage four non small cell adenocarcinoma with spread to brain. I have done gamma knife initially. Two years ago and had a new area this past winter in brain also treated with gamma knife. I believe I read a post of yours that you switched targeted therapy drug when you had progressing in brain. Is this correct. I do not think drs thought I would go this long on tarceva. I had a difficult time on site to finally ask you this question. If anything or advocacy about tarceva. Please let me know. Thank you. I enjoy your post

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