Photo by Rebecca Gould Photography

Tuesday, June 10, 2014


More Uncertainty.
A Plan.

A Change of Plan.

This is how it has gone...

For as much as IS known about food allergies, there is more (way, way more) that is not known.

As our pediatrician said recently:  "It's a magic kind of science."  Right.  Whatever THAT is.

When we left the Clinical Research Unit (CRU) on Monday afternoon, we did so with the understanding that we would (almost certainly) return on Wednesday morning, for an updose from 45 mg of peanut protein to 50 mg of peanut protein.  The small updose was indicated on the pharmacy protocol, and seemed odd until one of the doctors in the trial explained that the concentration of the peanut protein increased at the 50 mg dose, and then it all made sense.  

Given the severity of Susan's food allergies, I liked the idea of checking her tolerance to an increased concentration of peanut protein.  And, I also found myself embracing the idea of a very small updose.  I thought such a small increase would be -- easier, maybe?  Less stressful?  Maybe...more certain.

And so, while it clearly would have been preferable to schedule the updose for Thursday, since the updose was to be so small AND since Susan's sixth grade picnic was on Thursday, we scheduled it for Wednesday.

But, after seeing how fatigued Susan was on Monday night, by Tuesday morning, I was not so certain that updosing WAS the right plan.  (But, who was I to say?)

Uncertain, I sat down and composed an e-mail to the clinical trial coordinator.  Even re-reading it now, I feel my struggle to achieve a balance between being Susan's mother -- her advocate, her protector, her voice -- and being a participant in a clinical trial.  I do not know where the line, I am always going to err on the side of providing more information than is requested:

When we were in yesterday, we talked about coming back tomorrow (Wednesday) for the updose to 50 mg.  I'm game to try, but, I wanted to let you know that Susan was super tired yesterday.  She was asleep by about 4:45 pm and slept until we woke her for skating this morning at 5:00 pm.  

Susan says she feels fine.  And, she wanted to skate, even though she was still tired.  

When Susan's immune system is working hard, she sleeps (she always has -- if she gets a cold, she will often sleep almost straight for a day or two and then wake up feeling fine).  I don't know if her fatigue is related to the updose to 45 mg or if it is more as a result of the cumulative peanut exposure, or what...but, I wanted to be sure you knew.

We exchanged e-mail...a lot of e-mail.  

Eventually, it was decided that Susan would go in for an updose to 60 mg of peanut protein on Wednesday.  

60 mg

I was decidedly uncomfortable with this plan, but, after the clinical trial coordinator explained to me that the pharmacy protocol for updosing was, in fact, different than the protocol for the clinical trial, and that, there would NOT be an updose to 50 mg, I was not sure we had a choice.

If 60 mg was the next updose, then we were going to have to do it...(at some point, at least).

The day passed.

I picked Susan up from school to give her her peanut dose over lunch.

We discussed the plan of an updose to 60 mg of peanut protein on Wednesday, the following day.

Susan agreed (reluctantly) to the plan.

And, while I say Susan "agreed," I use the word...loosely.  For she "agreed" in the same way I agreed, I think.  While we did not talk about it, I could tell that she was was I.  And yet, rapid updosing IS the goal of the clinical trial.

That said, the 10 mg difference in peanut protein seemed enormous -- way more than the 4% of a peanut that it actually represented.

Knowing that the goal is for Susan to achieve tolerance to 2000 mg of peanut protein, which is the equivalent of EIGHT peanuts, I recognized the necessity of rapid updosing.  We have a long, long way to go.

By the time Susan had taken her peanut dose and we had allowed the observation period to pass (relatively uneventfully), and I had returned Susan to school, there was another e-mail from the clinical trial coordinator.  The e-mail was apologetic in nature, explaining that upon further consideration, the principal investigator did NOT want to have Susan updose on Wednesday, as she felt the increase would be too much, too fast.

Instructions were given.
Continue with the home dosing of 45 mg of peanut protein.

I was...relieved.  Very, very relieved.
And so was Susan.

For while we will have to face the 60 mg dose, we do not have to just yet...

(Susan's next updose -- to 60 mg of peanut protein -- is scheduled for Tuesday, June 17, 2014.)

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