#225812 - 02/15/05 07:54 AM
invited to participate in research study
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melissa
Registered: 07/05/04
Posts: 572
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Ok, this will be long, so forgive me up front. I've debated strongly on whether or not to post here. You see, I don't post a lot for fear of getting slammed. I have very few people I can talk to about PA and while sometimes I get scared reading this board I often get very good info. So here goes, and please when you're responding, take into account that I'm bringing this info to you to get your thoughts and see if you have other pros and cons that I hadn't thought of. My DH and I will ultimately make the decision. I also thought you would like to know about this research that is going on.
DS saw Dr. Wesley Burks last week at Duke. He is supposedly in the top 5 of docs working on PA. We were invited to participate in his study (the same one that Brooke, "benmadwood", is doing). Justin's caprast for peanut is a 25.7. Only those w/ a 15+ are entered into the study. Dr. B said w/ a 15+ you have a 95% of reacting to an exposure, and below a 15 the research isn't as clear cut. He also said w/ a 25 he has very little chance of outgrowing on his own (I can't remember what the cut off was for this and I know some of you would like that info...it may have been 15, or 5). We are struggling greatly w/ this decision. Here's how it would work:
First of all, this is made possible b/c Dr. B and other docs isolated the protein(s) in PN that cause the allergy. DS would get an IV (for emergency admin of epi if needed). He would get a tiny amount of peanut flour mixed in something like applesauce and be watched. Each 30 mins the amount would increase until he reaches 50 mg. If no reactions, he would leave, come back the next day and get the 50 mg again. Be watched, then go home. Every day for the next 2 wks we give him 50 mg. Each 2 wks for 3 months we go back and get an increased amount, are watched, and repeat for 2 wks. At the end of 3 mos he should be at the maintenance dose of 300 mg, the amount equivalent to about a peanut. Dr. B said most accidental exposures amount to less than a peanut. We would have blood taken every 3 mos for the remainder of 2 years. The possible outcomes are:
1. no benefit
2. ability to have an accidental exposure w/out a "major" reaction
3. no longer peanut allergic
This is supposedly safer than injections b/c it works in the gut (where reactions initiate I believe)...this is also the way people are "cured" of antibiotic allergies...they "eat" increasing amounts of the med until they no longer react. So far, there have been no serious reactions, w/ the worst being vomiting. No one has had a bad reaction at home, and the ones who did react at the first visit (vomiting) w/ a very small amount of pn flour are not reacting now on the highest maintenance dose.
Let me just say to you that I would not want anything to hurt my son. But it's very tempting to give him the chance to get rid of this constant fear that hangs over our family. The study is free, and we can stop at any point.
My pros are obvious. My cons/questions are the following:
1. what if he has a bad reaction?
2. what if this doesn't work and keeps him from outgrowing (even though we're told he has little chance of that)?
3. how traumatized will he be from having an IV and the blood tests?
4. putting him through this and it doesn't work
5. I will have to drive him 3 hours each way for these appts (the least of my concerns, but it is a factor)
6. It just seems too simple...eat a little peanut flour and get rid of the allergy?
I really hope I get some more pros and cons from you...as I said, I struggled w/ posting this b/c I don't want to be told in effect that I'm a bad mom for even considering this. But when no one else around you has a clue what you're dealing w/, this is the only place where I can come to.
Sorry for the length, but I wanted you all to have all the info I do, so you can give me your thoughts and plus so that you'll know what is going on in the world of PA research.
Thanks in advance,
Melissa
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#225813 - 02/15/05 10:52 AM
Re: invited to participate in research study
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Peg541
Registered: 12/29/02
Posts: 4280
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Melissa, first off I am sorry you are afraid to post. Stick around, give it a try. I doubt you'll get slammed.
Although lots of us have varying opinions about this kind of study so you might get lots of strong opinions which we welcome here so be prepared. But the opinions will help you make your decision.
Somewhere here on the bulletin board is someone who did this same study, I THINK. And had very good results.
Try a search, use the words research study or Duke University and see what you get. I know my first response to her query was something like NEVER but my last response to her was BOY I WISH MY SON HAD BEEN THERE!
I remember thinking Duke University was a place that certainly would not carry out a research study under bad conditions. They seem to be the place to be.
So here goes, after knowing what I know about the other person who did this, and knowing how much I want my son to GET RID OF HIS PA I would JUMP at the chance.
That's just me. Things happen in any research study and you have a BIG decision to make. Please don't use my words as gospel. If push came to shove and my son said NO WAY then we would not do it. He's 20 so we certainly would respect his wishes.
Good luck. Oh once Alison sees your post she will have lots to say, I believe she did something similar.
Peggy
_________________________
Peggy
Son 22 Allergic to peanuts, tree nuts, tomatoes, soy, milk, oats, fish.
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#225814 - 02/15/05 11:17 AM
Re: invited to participate in research study
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ajinnj
Registered: 05/13/03
Posts: 363
Loc: New York City, New York, USA
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I do have a lot to say, but not a lot of time. I'll post my opinion later today or tomorrow.
Also, linking http://uumor.pair.com/nutalle2/peanutallergy/Forum16/HTML/000146.html
Allison
[This message has been edited by ajinnj (edited February 15, 2005).]
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#225815 - 02/15/05 11:56 AM
Re: invited to participate in research study
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Peg541
Registered: 12/29/02
Posts: 4280
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Thanks Allison, that is the link I wanted to send Melissa to.
Peg
_________________________
Peggy
Son 22 Allergic to peanuts, tree nuts, tomatoes, soy, milk, oats, fish.
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#225816 - 02/15/05 01:25 PM
Re: invited to participate in research study
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ajinnj
Registered: 05/13/03
Posts: 363
Loc: New York City, New York, USA
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Hi Melissa,
I have a few questions for you. First, how old is your son? Will he be required to have an IV everytime he is given a new dose of peanut protein? Also, I just want to make sure I understand how the study works. The first two days, your son will be given increasing amounts of peanut protein (max 50 mg). This will be done in the hospital. After that, you give him 50mg for 2 weeks at home. Then back to Duke to get a higher dose (which will then be given for 2 weeks at home), etc.
The reason Peg pointed me out was because I have been in the tanox peanut study for the past 3.5 years, so I have first hand experience of what it’s like to be enrolled in a clinical trial.
I think the decision will really depend on your child. Depending on his age, I would ask what he wants to do. Your concerns are all quite valid. My personal opinion is that I wouldn’t worry so much about whether participating in the study will keep him from outgrowing his allergy. I would live as if he will be peanut allergic forever (b/c statistically speaking, he probably will). Again this is just MY PERSONAL opinion. Also in respect to your #4 concern, that it may not work; that’s the risk you take by participating in a study. However, from what Dr. Burke’s results so far, the treatment seems pretty promising. From what I’ve read, the other participant on this board seems to be having success.
Now for Con #1, that would be my biggest concern also. When I first read about this study, I thought to myself ABSOLUTELY NOT, but now I’m not sure what I would do in the same situation. Some questions to consider, what types of reactions (severity, etc) have other participants had at home? At what frequency have they occurred? Is there strict protocol to follow if your son does have a reaction at home (ie if he has this symptom, you do A. If he has this symptom you do B and C etc). Will Dr. Burke refer you to a health care provider closer to your home in the event of a reaction?
#3, Again this will depend on your individual child. I have been on and off allergy shots my whole life (starting at age 3). I was a HORRIBLE patient. My mom used to actually sit on me to get my shots. However, it was medically necessary therefore I didn’t have a say. We used to make allergy shot day, a “special day” (ie I would get a special treat if I behaved). This made the experience a little less traumatic. At the time, your son may scream and be miserable, but I think it will be more of a temporary thing and he will get used to/ get over it kind of thing. But again, this is only something you will know.
#5 I know you say this is the least of your concerns, but it is very legitimate. I used to live 1.5 hours from my study site. For the first year of the study, I had to wait at the hospital for 4 hours after my injections and I would get injections ever 4 weeks. This is a HUGE time commitment. It really dictates your life (vacations, other appointments, etc). I am now in college and pretty much chose my college based on the study site. Now, I really want to study abroad but cannot b/c of the study (I can choose to drop out at any time but I feel that the benefit of the drug does not warrant pulling out). Three years is a long time.
#6 I am in now way a scientist or doctor, but I think this treatment works in the same mechanism as environmental immunotherapy (allergy shots), which increases tolerance to an allergen by gradually introducing the body to the specific allergen. Several years ago, I tried to restart allergy shots (for the third time in my life). However, the injections would cause severe asthma exacerbations and I could never get past the second week (I would end up on very high doses of prednisone). Finally my doctor tried something called Rush Immunotherapy, where we went for zero to maintenance in one week. My shots started at very, very dilute amounts. Starting at 10am, I would get my shots with increasing amounts every hour until 5pm. This lasted for several days until I hit my maintenance amount (which ultimately resulted in anaphylaxis). Then we slightly decreased the dosage and continued in a regular time frame. By increasing the dosage every hour, my body did have time to react. The procedure kind of forced my body to go into overload (until I hit my max and then I reacted). After the procedure I was better able to tolerate the shots.
I have one more suggestion for you. Have you checked out the Xolair trials? In my opinion, the study is a little less risky. Although not a cure, the drug will increase your son’s threshold of peanut protein he can tolerate. There are sits all over the country (and links about the study on these boards).
So I guess I don’t really know what I would do in your situation. This is a very difficult decision to make. If your child is old enough to voice an intelligent opinion, I would ask him. However, if he is young, then I would do what feels good for you and your family. Because of the time commitment, this decision will affect your entire family.
Good luck.! Please keep us updated.
Allison
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#225817 - 02/15/05 03:23 PM
Re: invited to participate in research study
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melissa
Registered: 07/05/04
Posts: 572
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Peg and Allison,
Thanks for your thoughts. I have spoken w/ Brooke (Benmadwood) and am encouraged by her daughter's progress in the study.
To answer your questions:
1. Justin is 2. Not old enough to decide for himself, which is another issue for me. However, my 7 year old (no food allergies) who is petrified of needles said he would do it in a heartbeat if he could "eat anything I wanted".
2. The IV is only for the first visit. No more after that.
3. Allison, you understand the mechanics of the study correctly. Each time we return for Duke for a higher dose, he will be observed for 2-2.5 hours before going home.
4. From what I understand there have been no reactions at home. The only reactions I believe (and I'll get this clarified) have been on the 1st day when going from .1 mg (I think) to 50 mg and the most serious reaction was vomiting and some hives.
5. One of my questions for the doctor (on my list of many) is what protocol would I follow at home in case of a reaction, including who to see locally if need be in an emergency (I would want that person to be up to speed on what we're doing)
6. I think when I tell myself that the first visit will stink, then I just have to get him there 6 more times in 3 months, after that only once every three months, I can get past the travel issue. They would see us around lunchtime so that I can make it in one day, except of course for the first visit, which is 2 days.
7. I think as you do that this is the same principal as allergy shots, but the thinking is that by doing it through the gut rather than an injection cuts down on the serious side effects, but will hopefully provide the same benefit.
Allison, I think you're very brave to have done the Xolair study. I wish my son were old enough to make this decision himself. We're not rushing into anything, but it is on our minds constantly.
Thanks again for your input.
(and Peg, it's not so much that I am really afraid of getting slammed, I think right now my nerves are just very much on edge and I'm a little more "fragile" or whatever you want to call it; thanks for the help!)
Melissa
By the way, at this point, my son does not have asthma, and had very mild eczema as an infant, which now only crops up occasionally in one spot.
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#225818 - 02/15/05 03:30 PM
Re: invited to participate in research study
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Peg541
Registered: 12/29/02
Posts: 4280
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I tried to find a study of Xolair to get my son into, with his blessings. I sat there and cried on the phone when they told us there were no studies in our area or even close enough for him to tough it out.
I wish you luck. It's a tough decision to make.
And Melissa, I TOTALLY understand the fragile.
Peg
_________________________
Peggy
Son 22 Allergic to peanuts, tree nuts, tomatoes, soy, milk, oats, fish.
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#225819 - 02/15/05 08:47 PM
Re: invited to participate in research study
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sherkelsey
Registered: 08/19/04
Posts: 24
Loc: milwaukee, wi
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Hi Melissa,
My son is also 2 and reading your letter hit so close to home for me. I also often shy away from this board because I find it a bit overwhelming and I get scared. I know it is not the intention of anyone here, in fact everyone has been so helpful, it's just my own issue in learning to deal with this. That being said, I think I would TOTALLY sign my little guy up for this in a heartbeat! Obviously your concerns are legitimate and they would keep me up at night as well. But, on the flip side, I feel like the risk of accidental exposure is greater than the controlled exposure you will be faced with. And, you have the benefit of not being the first one to participate in this (thank you to those who have come before us) so you do have some positive history to base this decision off of. My only question is do the doctors recommend doing this at a younger age versus an older age? Have they seen any benefit besides reducing their risk to accidental expoure if they are treated at a younger age? I'd be curious to know if they ahve had the same success with "older" participants.
I'm anxious to hear what you decide. Please keep us posted and we will keep you and your family close in prayer. Thank you for your courage.
Sherri
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#225820 - 02/15/05 11:14 PM
Re: invited to participate in research study
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ajinnj
Registered: 05/13/03
Posts: 363
Loc: New York City, New York, USA
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Two more questions for you: has your son had any previous reactions to peanuts and if so what were his symtpoms. Also, does he have any other food allergies besides peanut?
Allison
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#225821 - 02/16/05 12:51 AM
Re: invited to participate in research study
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Peg541
Registered: 12/29/02
Posts: 4280
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I asked my son how he felt about this. Maybe I wish I had not asked because we both got sad.
His reply was:
"I don't know, mom. Not something that can just be asked. I need to sit under a tree somewhere and contemplate for like a year. Give me time"
He later told me he would be too scared to take the first bite. He very well remembers how his reactions felt because he had his first at age 14. His cap rast number is 20.7 if I am reading it correctly.
So maybe for a younger child yes. Someone like my son who is 20 and has grown up with his PA has too many defenses and fears. And also like AnnaMarie said in another thread, my son knows how to handle his PA, it's not fun but he's OK with it.
Maybe the devil you know is better than the devil you don't know.
I wish you luck in your decision.
Peggy
[This message has been edited by Peg541 (edited February 16, 2005).]
_________________________
Peggy
Son 22 Allergic to peanuts, tree nuts, tomatoes, soy, milk, oats, fish.
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