Susan is in a clinical trial at Lurie Children's Hospital in Chicago.
The clinical trial is called PRROTECT.
There are nine (9) subjects in the double-blind trial.
Two (2) of the subjects are controls.
Seven (7) of the subjects will receive injections of the medication Xolair, which is believed to decrease the body's autoimmune response thereby increasing success rates in oral immunotherapy (OIT).
All subjects in the study will (eventually) receive the Xolair, as any subject who does not make progress toward increasing tolerance of peanut by Week 19 (the standard is tolerance of 250 mg of peanut) will begin receiving open-label injections of Xolair.
For those who do not know Susan, I am certain that it sounds like we are taking many big risks...
And, we are.
But, Susan's allergy is so extreme and has affected her life in so many ways that we feel the opportunity to receive the Xolair in conjunction with OIT is well worth the risk.
While some who participate in OIT have to worry about worsening of the allergy, we feel Susan's allergy is already so bad that this risk is worth taking.
For us, the clinical trial has never been about Susan being able to eat handfuls of peanut and whatever other peanut she wishes all day long...
The clinical trial is about decreasing the daily risks she faces (she has had multiple well-documented airborne and contact anaphylactic reactions over the years) in an effort to increase her overall quality of life.
Some day, she wants to:
Fly -- to places she will get a stamp in her passport, like Greece, Egypt and Spain.
Eat Samples -- at Whole Foods, Mariano's and Caputo's.
Watch a Movie -- first release, big screen, maybe even 3-D...in a movie theater.
Since we started the clinical trial, we have become increasingly aware of the potential impact of this work (and other clinical trials like it), and we have begun to appreciate how Susan's role in this particular clinical trial is part of something much bigger than what it might mean for her alone. Even though it appears at this point that Susan is either in the control group or the Xolair is not effective for her, Susan intends to see the clinical trial through. (That said, it is entirely possible she HAS BEEN and IS receiving the Xolair...maybe it HAS been more effective than we think...who knows?)
Where we are now:
After Friday's "successful" 15 mg dose of peanut in the Clinical Research Unit (CRU), Susan's home dose of peanut protein was set at 15 mg, which is equivalent to 3/50ths of a peanut, or 0.6% of a peanut. That's not a lot, but, it was enough to scare me.
Before we were discharged from the CRU on Friday, we reviewed the home dosing instructions. The documents that came with the dosing instructions were sobering, and as I went over the instructions with the clinical trial coordinator, I was thrust suddenly back in time -- to nearly 14 years ago -- after my husband's kidney transplant. In this instance the brown paper bag was the size of a lunch sack, and contained only one vial of "medication" whereas my husband's fifteen (15) post-transplant medications nearly filled a grocery bag. Volume aside, the similarities struck me as otherwise quite similar. In both situations, I held medications that could mean the difference between life and death for my loved ones. Mismanaged, the consequences could be...terrible. Devastating.
Dr. R. called me Friday night -- to check on Susan and to review the instructions and review the plan for the timing of Susan's first home dose.
I do not think it is possible for me to say often enough how thankful I am for the medical professionals running this particular clinical trial, for they truly see Susan as a person...not just a subject in a study.
The timing and scheduling of the home doses is WAY more important and complicated than I anticipated it to be. Not less than 12 hours between the last and the next dose. No more than twenty-four hours plus four hours (that's 28 hours, but, in clinical-trial speak, they talk about it in terms of 24 + 4) between doses. No showers for two hours before or after. No physical activity for two hours after. Parental observation for two hours after.
Dr. R. reiterated the importance of giving the first home dose no more than twenty-four hours plus four hours after the last dose. As Susan's dose on Friday was given in the morning at the CRU, and our ultimate goal is to do her home dosing at night (crucial given that she skates every morning), we had to shift the doses later in the day -- in no greater than four hour increments.
After some discussion, we settled on a 1:30 pm dose on Saturday, with a dose around the same time on Sunday, and a shift later in the day on Monday -- aiming for about 5:00 pm. Perfect. Thank goodness for the three-day weekend.
Saturday morning, Susan was up at 5:00 am. She was on the ice by 6:00 am, and was SO HAPPY to be there -- it makes me glad she has a place -- a community -- that she can call home (away from home). She has an awesome group of friends who are both older and younger than her and she is as comfortable there as she is in her favorite space at home -- her room.
After skating, Susan took a shower (the timing of showers has become EXCEPTIONALLY complicated, as she is not to shower two hours before OR after she takes her peanut dose -- which effectively eliminates showering after school or at night...and as she hits the ice at 6:00 am most mornings, a before-skating shower means a VERY EARLY wake-up. This is just one example of the ways in which the realities of home dosing are so very much more difficult than we ever imagined...
As Susan went about her day, the minutes ticked by.
9:30 am (4 hours to dose)
10:12 am (3+ hours to dose)
10:30 am (3 hours to dose)
I am not going to look at the time again.
And then I found myself wandering into the kitchen, and ever-so-casually, noted that it was 10:46 am.
The minutes ticked by.
As I thought about the reality of the first home dose of peanut protein, I realized Susan would likely do best if she did not have an audience of four (me, my husband and her 2 siblings). That said, I really liked the idea of NOT being the only one home with her -- what if I needed something and did not want to leave Susan?
As much as I dreaded the first home dose, I also looked forward to just having it done -- to being able to look at Susan and have us both know that we had been able to handle it -- whatever "it" turned out to be.
So...I created a list of errands and sent my husband and our dramatic younger daughter off to do my bidding. The list included book titles specifically requested by Susan for her read-a-thon...which turned out to be sufficiently difficult to obtain, and, therefore, consumed a good amount of time.
As 1:30 drew closer, I confirmed that Susan wanted to take her peanut dose in Sunbutter (a sunflower seed based peanut-butter alternative) with apple slices. She did.
I wiped off a section of our table and peered into the brown paper bag.
It is hard to believe that I was afraid of the contents, but, I was.
I carefully, and ever-so-slowly laid out the prescription bottle filled with peanut protein, the clinical-trial supplied measuring spoons and the plastic "soufflé cups" they had provided for us to mix Susan's doses in.
I didn't want to be nervous, but, I was.
I was acutely aware of the fact that I was about to feed my daughter a substance (a food!) that I had spent years -- and countless hours and dollars -- avoiding. I was about to feed my daughter a food that brought tremendous controversy to our school district and irrevocably changed the landscape of my friendships. I was about to feed my daughter something I KNEW could kill her -- in my own home.
Preparing to purposefully feed Susan peanut -- in our home -- the one place I have tried to ensure she ALWAYS feels safe -- was SO, SO much more difficult than it had sounded when I read the parental consent form for the clinical trial.
I squished the Sunbutter into the "soufflé cup" provided by the Clinical Research Unit (CRU)
My hands were shaking -- and bits of that deadly peanut protein fell onto the table where my family eats every day. I recognized the problem immediately -- I needed something under my work surface to catch that poison so that there was no risk of Susan accidentally encountering it at ANY point in time. A mistake I would not (will not ever) make again.
Eventually, I managed to get Susan's dose -- in three 1/4 teaspoon increments of peanut protein suspended in flour -- into the "soufflé cup" supplied by the hospital.
When I was done, that peanut protein sat atop the contents of a pouch of Sunbutter, and I was left to mix it in...slowly, ever -- EVER so slowly so that no deadly (peanut) dust could escape.
As I mixed, slowly and carefully integrating a food my daughter loves with a substance that has the power to kill her, I marveled at how very far we have come...and I was thankful (once again) that no matter how breathtakingly scary and paralyzingly frightening this is...we have this opportunity. For as frightening is the opportunity is, it is also -- incredible.
As I struggled to make sense of the idea that the very thing that might cure Susan -- that could open Susan's world in a way we can only dream of -- was also the very thing that could kill her, I vowed to put my doubts aside -- and to embrace this incredible work we (she) are (is) doing. (That didn't last very long, but, it was a noble concept...)
We have special green plates (and bowls) in our house -- for truly awesome times: birthdays, tests or papers or school projects well done, soccer goals, awesome goalie saves, record setting skates, speedy runs, eating something that could kill you. And so, with part of me hating myself while I did it (and the other part of me LOVING that we could celebrate a moment of eating peanut in our home), I served Susan's first home dose of peanut to her on a green plate. She (of course) didn't bat an eye. It made total sense to her -- with no visible room for doubt.
Incredible. Susan ate it all. No complaints (although she was also pretty quick to say that she thought she would have it in chocolate pudding tomorrow...) And while I am realistic enough to know that she has made a choice to see this through, even now -- looking at the empty soufflé cup, I paused. Susan truly is beyond brave. Where do these kids come from -- and WHY must they face these challenges?
We don't really talk about it (and NOT because I haven't put my social worker hat on and tried, let me assure!)...but, just imagine what it must be like to knowingly spoon something into your mouth that could kill you? Something that has already stolen your breathe and made your body not your own? HOW MANY of us would do it? HOW MANY of us can even imagine what it is like?
After Susan was done eating her Sunbutter, peanut and apple snack, she followed it up with four ounces of cold water (how do they arrive at knowing such things?), and I set an alarm on my phone to go off ten minutes later. The observation period had begun (in more ways than one).
Susan hanging out with Ga, her lovie -- and Sophia, "her" cat -- at the beginning of the observation period.
When my alarm went off ten minutes later, after "snoozing" my alarm so that I would have a prompt to check her again 9 minutes later, I looked at Susan carefully. She looked ever so slightly flushed to me. But, I had to wonder -- did she look flushed because I was examining her with the upmost of care, or was she actually flushed? I wasn't sure -- that's how subtle the difference was 10 minutes in.
It turned out that I didn't need the "snoozed" reminder -- once I started thinking Susan looked flushed, I could not STOP looking at her. I didn't want to irritate her, and I KNOW she doesn't like being studied, but, how could I help myself? I tried to look surreptitiously, but, she knew she was being watched. And I could tell my intent interest in her was making her...uncomfortable, at the very least.
And so, I apologized...and we both laughed...and I was reminded, again, of her commitment to this clinical trial -- in so many ways -- big and small.
And then, even though I SO did not want to have to check the box on the Daily Peanut Dosing Diary indicating that Susan had had symptoms, not only was she flushed, but, her cheeks -- and then her chest and her back -- were covered in a red, rashy, hivey looking irritation.
I took pictures.
I wanted photographic proof of both how Susan's skin had looked at the time AND a reference for myself for the rest of the observation period.
The minutes dragged.
I watched for the tiniest sign of a change.
And, I took more photos...her skin grew more irritated looking...but, she otherwise felt fine. Thankfully.
About the only positive thing I can say about the way her skin was looking is that it did not itch. Sure looks like it would have...but, thankfully, it didn't!
As we observed, I sent my son (who was really concerned about Susan and therefore readily and truly willing to do whatever we asked) to the kitchen to put together a snack for Susan -- Special K and milk. I would have let her eat pretty much whatever she wanted as a snack to support her body's digestion of the peanut, as the combination of the peanut dose, water and a snack had worked the previous day -- and yet, I was also thankful that she (reliably, in her own, typical Susan way) picked something that was healthy.
The minutes ticked by. I snoozed my alarm several times -- checking Susan carefully at every interval. Another snack (less healthy -- frozen cookie dough from Market Day) -- ticked by. And while Susan's skin did not improve, she had no other symptoms.
I wondered about what to do about Susan's skin...and I wondered some more...and I thought about paging the on-call doctor (who just happened to be Dr. R.). And then, I decided to stop wondering...and to page Dr. R. Part of me wanted to wait a bit and see what happened, and the other part of me -- so didn't. I didn't want to try to make sense of these brand-new, foreign symptoms on my own.
Never knowing exactly how an exposure to peanut will affect Susan makes it hard to know how to respond -- especially when the reaction is something new. Susan had NEVER had her skin look the way it was looking...and without some previous experience to help guide me, I really wasn't sure what to think about the way things were going.
So...setting aside all that internal uncertainty, I paged Dr. R., who, of course, called me back right away. I immediately provided the same reassurance I always want the school nurse to provide, as my words rushed out in a jumble: "It's not terrible -- but, I wanted to tell you what is happening with Susan's skin." I think I heard relief in Dr. R.'s voice...and I was so thankful to have her wisdom on the other end of the phone.
We talked at length about the way Susan's skin looked -- her "hives," as I was calling them -- for lack of a better word...although as we have VERY limited hive experience and I wasn't entirely certain that that was the right word...
I offered to send pictures, but, Dr. R. trusted my description.
I like this partnership.
And then, we made a plan. I really appreciate that about the doctor's and clinical trial coordinators -- I always feel like I have a plan, like I know...what to do next -- even in the face of the terrible uncertainty of food allergies -- and even knowing that what to do next might change in the near future, I always feel like -- even if only for the moment -- I have clear direction.
-- If Susan's "hives" were still present at the end of the two-hour observation window, I would give Susan 25 mg of Benadryl (Susan could safely have taken more, but, she had a soccer game to play that night, and no one -- except maybe the other team -- likes a sleepy goalie).
-- Begin 20 mg of Famotidine approximately thirty minutes before Susan's home-dose on Sunday (and going forward).
Sobering -- Daily medications added since introduction of daily peanut dose:
10 mg Zyrtec -- morning
20 mg Famotidine -- 30 minutes before peanut
And then, almost before I knew it, the required two-hour observation window was over. And yet, really, for me, it was also just beginning. With a history of delayed reactions and the hivey, rashy thing Susan had going on, I realized that I was NOT prepared to leave her alone...
And so begins a new chapter in our lives.
Later, with me, watching ever so carefully from the sideline...Susan and her team played a great game.