After the clinical trial coordinators requested
permission from the site coordinator to move Susan to the open label Xolair injection
arm of the clinical trial due to Susan's inability to tolerate increasingly
high doses of peanut, Susan and I felt relieved...and oddly, strangely, a bit
disappointed -- almost as though Susan's inability to tolerate progressively
higher doses of peanut was a failure in some way. [For those who have missed an entry or two,
in Week 17, Susan was taking, but not tolerating a 60 mg dose of peanut
protein. The Clinical Trial doctors
decided to decrease her dose to 45 mg of peanut protein in the hope that she
would tolerate it. This was a move in
the wrong direction, as the goal was for Susan to be able to tolerate 250 mg of
peanut (one whole peanut) by Week 19, which looked less and less likely as she
struggled to tolerate the updoses.]
Failure.
Yes.
That sounds a bit crazy, even to me, but it is true.
This feeling -- that we [Susan?] had failed in some way was
underscored (and EXPLAINED -- thank you) by a dear friend when she said: "I am so sorry the clinical trial did
not work." I paused, seeing clearly
-- understanding -- the feelings of failure.
It was with relief that I explained to my friend that it
was possible that the clinical trial worked exactly the way it was supposed to
-- if Susan was in the control group...IF
those painful, burning injections she endured every other week for twelve weeks
were...the placebo.
And so, it was with mixed feelings that we drove into the
city for our appointment in the Clinical Research Unit (CRU) on Tuesday. While I was thrilled beyond belief by the
knowledge that Susan would begin receiving open label injections of Xolair,
there was a part of me (that fretful, worrisome, negative part of me) that
wondered -- were we starting anew -- returning to Week 0 only to go down a
similar (hard) path in twelve weeks?
(This is, of course, only likely in the highly unlikely event that Susan has been receiving Xolair
injections from the start...)
While Susan gave voice to this possibility, wondering
aloud if Xolair ever does not help someone, when I think about her mood,
the mood in the room...when I look at the pictures I took...I know she was
feeling hopeful...optimistic, and I was, too (well, mostly...save for that
little voice lurking in the back of my head...)
Susan was all business during the breathing tests.
And I could not resist photographing the pre-prepared, clearly labeled syringes filled with what
I hope is a miracle medicine for Susan...
[I have already had several people ask -- why THREE injections? It does seem rather a lot, I would agree -- while I don't know the amount in each syringe (although I suspect I could have known had I thought to turn over the syringes), I do know that this is the dosage that was calculated based on Susan's IgE levels at the time she was enrolled in the clinical trial -- First Food Challenge.]
Susan was the most relaxed I have ever seen her during the injections. (Of course, we were TOTALLY joking around with her...and I am sure it did not hurt knowing that she was receiving open label injections of Xolair.)
She went from serious...
To..smiling. As mom, I know that is a for-real smile. With hope like this, how could she not smile?
And then (because we were being really goofy -- and not a one of us in the room could sing AT ALL), Susan was cracking up! (How could she not? Even I was laughing at how pathetic we sounded...)
And then, even though she was getting an injection (her third), Susan was "licking up her baby bumblebee!" I love that Lydia's mother's antics carried over as they did during this visit to the CRU (Surreal).
I could not help but grill Susan after the injections:
-- Did you feel anything any different?
-- Was there anything AT ALL different? Anything? At ALL?
No, mom.
(As I told myself -- it means nothing. Right? Right. But still...I wonder...)
Because Susan is now in Week 0, everything starts again -- including the two-hour observation period post-Xolair injections (this is true for the first three injection visits). Allergic kids are allergic to things -- including...um, medication. So, it is really important that they be observed after a new medication is introduced.
So, Susan and I settled in to wait. We knew there would be a blood draw (SO last on Susan's list)...but, other than that, we had no great plans for the two-hour waiting period. Wait. That's not true. She intended to royally beat me at Bejeweled Butterflies...but, other than that, we had no real plans.
-- Did you feel anything any different?
-- Was there anything AT ALL different? Anything? At ALL?
No, mom.
(As I told myself -- it means nothing. Right? Right. But still...I wonder...)
Because Susan is now in Week 0, everything starts again -- including the two-hour observation period post-Xolair injections (this is true for the first three injection visits). Allergic kids are allergic to things -- including...um, medication. So, it is really important that they be observed after a new medication is introduced.
So, Susan and I settled in to wait. We knew there would be a blood draw (SO last on Susan's list)...but, other than that, we had no great plans for the two-hour waiting period. Wait. That's not true. She intended to royally beat me at Bejeweled Butterflies...but, other than that, we had no real plans.
And then, the clinical trial coordinator offered us what can only be described as a gift (although I doubt she saw it that way, doubt she understood the significance of what she was offering us...). She suggested that Susan take her 45 mg peanut dose during the post-Xolair injection window.
We didn't talk about it, but, we didn't have to.
We were both thrilled.
She took care of ordering a pre-measured dose from the pharmacy (if I never had to measure a dose of peanut protein again -- especially in my own home -- it would be perfectly fine with me, although, of course, this is part of what we have signed on for, and I will continue...).
Then came the task of figuring out what Susan would take her peanut dose in. Options were limited, as she WILL NOT do applesauce and she would prefer not to do chocolate pudding [oh, she knows she will have to eat chocolate pudding during the food challenge (or applesauce!), but, other than that, I think she is trying to avoid chocolate pudding...].
I was so frustrated, because the clinical trial coordinator offered two very viable options -- ice cream and Italian Ice. Both options were available on the CRU, but, they were so poorly labeled that I had to actually call both companies to find out whether or not there was risk of cross-contamination with peanut. (I do not take issue with the fact that these products were available on the CRU, as this unit serves any number of children with various medical concerns -- but, I am ever so frustrated by our country's exceptionally poor food labeling laws. That's "next" on my list.) Neither product was safe.
Susan, who liked the idea of taking her peanut dose in the CRU for -- oh, let me count the endless number of reasons -- was more flexible about the vehicle in which she would take it than usual. After discussing our dwindling options, she settled on yogurt. I went down to the cafeteria, where I was pleasantly surprised to discover a wide array of yogurts. Loving technology, I texted the options to Susan, who picked blueberry Yoplait. She is lump-averse when she takes her dose (hence the regular use of the Bullet blender), and felt the blueberries would disguise any lumps...
We didn't talk about it, but, we didn't have to.
We were both thrilled.
She took care of ordering a pre-measured dose from the pharmacy (if I never had to measure a dose of peanut protein again -- especially in my own home -- it would be perfectly fine with me, although, of course, this is part of what we have signed on for, and I will continue...).
Then came the task of figuring out what Susan would take her peanut dose in. Options were limited, as she WILL NOT do applesauce and she would prefer not to do chocolate pudding [oh, she knows she will have to eat chocolate pudding during the food challenge (or applesauce!), but, other than that, I think she is trying to avoid chocolate pudding...].
I was so frustrated, because the clinical trial coordinator offered two very viable options -- ice cream and Italian Ice. Both options were available on the CRU, but, they were so poorly labeled that I had to actually call both companies to find out whether or not there was risk of cross-contamination with peanut. (I do not take issue with the fact that these products were available on the CRU, as this unit serves any number of children with various medical concerns -- but, I am ever so frustrated by our country's exceptionally poor food labeling laws. That's "next" on my list.) Neither product was safe.
Susan, who liked the idea of taking her peanut dose in the CRU for -- oh, let me count the endless number of reasons -- was more flexible about the vehicle in which she would take it than usual. After discussing our dwindling options, she settled on yogurt. I went down to the cafeteria, where I was pleasantly surprised to discover a wide array of yogurts. Loving technology, I texted the options to Susan, who picked blueberry Yoplait. She is lump-averse when she takes her dose (hence the regular use of the Bullet blender), and felt the blueberries would disguise any lumps...
See how happy she looks?
It was (unfortunately) fleeting...
As she prepared to take the first spoonful, she had one of those unusual (and predictive) burps...and then she vomited violently. I was stunned. So was she. It happens so fast.
As stunned as I was (I THOUGHT she was tolerating the 45 mg dose), I was almost relieved to have it happen while she was sitting there, in the CRU. The doctor, who was not in the room at the time, did NOT miss the action, as there is a glass window between the office she was in and the room Susan was in. No one has ever given any hint of disbelief when I have called to report these episodes of vomiting, but, still, I liked knowing that they had seen it happen.
And then I was struck by a horrible thought -- what if the vomiting meant Susan wasn't tolerating the Xolair?! Fortunately, given Susan's very recent history, no one thought that!
Pre-dose vomiting = Pause, Information Gathering, Consultation and then a Pow Wow.
In the end, Susan and I were given the opportunity to weigh in heavily on the question of dosing.
Arguments in favor of holding Susan at the 45 mg dose:
-- Decreasing a dose (and we had already decreased her dose from 60 mg to 45 mg) can result in greater intolerance...(this is a theory...no more science in my mind than much of the rest of this...)
-- The fact (let's face it -- hope) that the Xolair (maybe even the three injections she received on this day) should begin to help with tolerance issues
-- Achieving tolerance of 45 mg would likely improve Susan's chance of reaching tolerance of 2000 mg
-- Safety concerns
Arguments in favor of decreasing Susan to a 30 mg dose:
-- Greater likelihood of tolerance going forward (this was short-term thinking)
-- Decreased stress on her body (mind, and soul)
-- The idea that if her immune system was less stressed, she might respond more favorably to the Xolair
-- Safety
Laid out as it is above, it seems pretty clear (retrospectively) that we should move to a 30 mg dose...but, it really was a difficult decision as we sat there with the doctor and the clinical trial coordinator. I was clear that I could argue the decision both ways, as was the doctor. In the end, when Susan said she wanted to decrease the dose to 30 mg, the decision was easy. With no clear-cut, easy answer, Susan's clear preference made the decision easy. After all, in this land where Susan has so little control, I liked the idea of giving her some control...
A medication was added...
And the clinical trial coordinator called the pharmacy (again), which, in turn, provided us with a 30 mg dose of peanut protein.
I went back down to the cafe and purchased my second blueberry Yoplait of the day, which Susan consumed without issue (phew!).
Then we had the small issue of what to do with the blueberry Yoplait yogurt that had the 45 mg dose of peanut in it. I could not eat it, as the peanut is cut with flour (read: gluten). And try as we might, we just couldn't get anyone on the CRU to eat it!
So, there it sat...
Lonely.
Alone.
(Contaminated.)
As we hung out, waiting for the two-hour observation period to pass, I turned the peanut dosage decision over and over in my mind. While I was feeling relieved and thankful that Susan would be taking a dose she had tolerated fairly well (setting aside the vomiting-outside-M. Henry incident), I could not help but reflect on how difficult the road had been for the little ground we had achieved...
Susan's dosage road map. Laid out this clearly gives credence to everything I have felt and said about how difficult this time has been for Susan, for me, for our family...a road nearly to nowhere (and back).
May 22, 2014 -- 30 mg home dose
May 23, 2014 -- 15 mg home dose
June 2, 2014 -- 22 mg home dose
June 5, 2014 -- 30 mg home dose
June 9, 2014 -- 45 mg home dose
June 17, 2014 -- 60 mg home dose
June 20, 2014 -- 45 mg home dose
June 24, 2014 -- 30 mg home dose
If not for the three open label Xolair injections Susan received, I am sure we would both be incredibly discouraged...
As I sit processing the dates and dosages I laid out above, I am struck not only by Susan's perseverance, but by her doctors' perseverance. This has not been an easy road. And I am so thankful for their steady support through this time.
Week 0 included a blood draw, and the great nurses in the CRU brought out Buzzy Bee again. Having read the science behind Buzzy Bee, I am fairly certain it is not just his darling face that helps during painful procedures, but, it certainly didn't hurt that Susan giggled when we tucked Buzzy Bee into her sleeve...
As stunned as I was (I THOUGHT she was tolerating the 45 mg dose), I was almost relieved to have it happen while she was sitting there, in the CRU. The doctor, who was not in the room at the time, did NOT miss the action, as there is a glass window between the office she was in and the room Susan was in. No one has ever given any hint of disbelief when I have called to report these episodes of vomiting, but, still, I liked knowing that they had seen it happen.
And then I was struck by a horrible thought -- what if the vomiting meant Susan wasn't tolerating the Xolair?! Fortunately, given Susan's very recent history, no one thought that!
Pre-dose vomiting = Pause, Information Gathering, Consultation and then a Pow Wow.
In the end, Susan and I were given the opportunity to weigh in heavily on the question of dosing.
Arguments in favor of holding Susan at the 45 mg dose:
-- Decreasing a dose (and we had already decreased her dose from 60 mg to 45 mg) can result in greater intolerance...(this is a theory...no more science in my mind than much of the rest of this...)
-- The fact (let's face it -- hope) that the Xolair (maybe even the three injections she received on this day) should begin to help with tolerance issues
-- Achieving tolerance of 45 mg would likely improve Susan's chance of reaching tolerance of 2000 mg
-- Safety concerns
Arguments in favor of decreasing Susan to a 30 mg dose:
-- Greater likelihood of tolerance going forward (this was short-term thinking)
-- Decreased stress on her body (mind, and soul)
-- The idea that if her immune system was less stressed, she might respond more favorably to the Xolair
-- Safety
Laid out as it is above, it seems pretty clear (retrospectively) that we should move to a 30 mg dose...but, it really was a difficult decision as we sat there with the doctor and the clinical trial coordinator. I was clear that I could argue the decision both ways, as was the doctor. In the end, when Susan said she wanted to decrease the dose to 30 mg, the decision was easy. With no clear-cut, easy answer, Susan's clear preference made the decision easy. After all, in this land where Susan has so little control, I liked the idea of giving her some control...
A medication was added...
And the clinical trial coordinator called the pharmacy (again), which, in turn, provided us with a 30 mg dose of peanut protein.
I went back down to the cafe and purchased my second blueberry Yoplait of the day, which Susan consumed without issue (phew!).
Then we had the small issue of what to do with the blueberry Yoplait yogurt that had the 45 mg dose of peanut in it. I could not eat it, as the peanut is cut with flour (read: gluten). And try as we might, we just couldn't get anyone on the CRU to eat it!
So, there it sat...
Lonely.
Alone.
(Contaminated.)
As we hung out, waiting for the two-hour observation period to pass, I turned the peanut dosage decision over and over in my mind. While I was feeling relieved and thankful that Susan would be taking a dose she had tolerated fairly well (setting aside the vomiting-outside-M. Henry incident), I could not help but reflect on how difficult the road had been for the little ground we had achieved...
Susan's dosage road map. Laid out this clearly gives credence to everything I have felt and said about how difficult this time has been for Susan, for me, for our family...a road nearly to nowhere (and back).
May 22, 2014 -- 30 mg home dose
May 23, 2014 -- 15 mg home dose
June 2, 2014 -- 22 mg home dose
June 5, 2014 -- 30 mg home dose
June 9, 2014 -- 45 mg home dose
June 17, 2014 -- 60 mg home dose
June 20, 2014 -- 45 mg home dose
June 24, 2014 -- 30 mg home dose
If not for the three open label Xolair injections Susan received, I am sure we would both be incredibly discouraged...
As I sit processing the dates and dosages I laid out above, I am struck not only by Susan's perseverance, but by her doctors' perseverance. This has not been an easy road. And I am so thankful for their steady support through this time.
Week 0 included a blood draw, and the great nurses in the CRU brought out Buzzy Bee again. Having read the science behind Buzzy Bee, I am fairly certain it is not just his darling face that helps during painful procedures, but, it certainly didn't hurt that Susan giggled when we tucked Buzzy Bee into her sleeve...
And when the blood draw was over, Susan got an awesome flower-power Band-Aid. The nurses actually buy fun Band-Aids and donate them to the hospital...Susan and I have begun collecting fun (latex free) Band-Aids...
Because, in a clinical trial for peanut allergies, the Peanuts Band-Aids the hospital has had for years simply don't do it!
Sobering -- Current list of medications added since introduction of daily peanut dose:
10 mg Zyrtec -- morning20 mg Famotidine -- morning
20 mg Omeprazole -- 1 hour before peanut dose
After two hours, we were cleared for departure (from the CRU). I joked to Susan that maybe some day because of all that she is enduring now -- she will be "cleared for departure" for real. It has been so many years since she has flown that she didn't get it.
We had a quick lunch at Maggiano's and then hit Barnes & Noble, where Susan found a new (to her) three-book series. Susan was in a good mood -- the 30 mg dose felt very easy to her, and she was happy to have received the Xolair injections...
It was all good.
We had a quick lunch at Maggiano's and then hit Barnes & Noble, where Susan found a new (to her) three-book series. Susan was in a good mood -- the 30 mg dose felt very easy to her, and she was happy to have received the Xolair injections...
It was all good.
Happy Skating Hands
With a darling skating buddy.
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