Re: Neratinib Clinical Trial
 

Hi Kriss -
Nice to see you, but not your symptoms. At least you must be getting the anti-cancer effect along with the side effects. Let us know how the rest and restart goes.

Perhaps your diet must be adjusted as well. The gals on Tykerb found that to be usually the case.

Re: Neratinib Clinical Trial
 

Kriss,
Hang in there, hopefully they will be able to find the right dose for you.

I remember last year at San Antonio when they reported the results out on the initial Neratinib trials, diarrhea was universal (In the study participants, not among the people hearing the report) Afterwards Dr. Love commented in the Alamo Mentor session that it sounded like prep for a colonoscopy!

But interestingly enough NOBODY had discontinued the trial due to this. The population in that study was Stage IV patients so that may have made a difference, but it did seem that most people eventually were able to manage the side effect.

Good luck, thank you for participating in the trial

Re: Neratinib Clinical Trial
 

Thanks ladies for the support. After going to the bathroom 37 times in a 24 hour period and vommiting they took me off the drug for 10 days. After one missed dose I feel like a new person, almost back to normal. This will at least get me through the holidays. I plan to try it again. They are not sure yet if I will challenge the dose a gain or since my reaction was so violent start me at a lower dose. Steph, what kind of changes did they make to their diet? I'm trying to do low to no fat. I don't eat red meat, and have been trying to cut out dairy. Is there anything in particular?

Re: Neratinib Clinical Trial
 

Kriss,
When I was on Tykerb, I had problems, but they were not as severe as yours. I learned to take two imodium along with one Lomotil as the very first sign of a cramp. I had no diary and went on a low fiber diet. I could not eat fresh fruits and veggies. If you Google "low fiber" diet you will find some helpful information. The only green vegetables I could eat without problems were green beans and asparagus. I also switched to white bread as whole grain did a number on me also. Basicially, I just stopped those healthey habits I had developed as far as eating fiber was concerned. My dosage had to be lowered, but I feel that I was very lucky to have the opportunity to take the drug. I also found that a baked potato usually gave me no problems. I basicially ate meat, bread, and potatoes. Good luck and keep adjusting your diet. I took my last Tykerb Nov. 17th and within two days my stomach that I had had for a year completely disappeared. I am now eating fruit, veggies, and drinking more milk that I need. You will be too!!
Sandra

Re: Neratinib Clinical Trial
 

Kriss,

Ugh. Hang in there!

Kind of an odd "blind" trial when the side effects are so evident. Did you react upon the very first dose? How many doses did you take?

Wishing you luck,

TRS

Re: Neratinib Clinical Trial
 

I took the 1st dose at bedtime and the symptoms started first thing in the morning. By the 3rd day it was unbearable. They started me again on Monday and dropped my dose to 200mg. I started the lomotil at the same time. this time around it is not as bad but still not great. The diarreah started immediately but only maybe 8 or 10 times a day. I changed my diet again using some of the guide lines Steph had tried and think it is all helping. I feel very fortunate to be part of the trial and am pretty confidant that I am getting the real thing. But honestly I am just so pleased that I can give back or pay it forward. I know without all those brave women that were part of the herceptin and many other trials I may not be here to do this. So I will take the diarreah and all the other stuff. Have a blessed day ladies.

Re: Neratinib Clinical Trial
 

Kriss,
I started the trial on Oct 7 and have the violent side effects like you did AND I ended up with severly depleted potassium and magnesium from the diarrhea. They found all that at my 1 month appointment and I spent the next two months trying to get potassium and magnesium back to normal and going through dose reduction.
I reduced to 200 mg and have almost as violent a reaction as the 240 mg, uncontrollable diarrhea with lomotil and immodium and still had problems with potassium and magnesium.
I got reduced again to 160 mg and it has been a WORLD of difference- I think we finally found a dosage my body can handle!!!!!

Talk to your nurse if it is still that bad- she should have the guidelines to get you to a dose that is tolerable!

Kristy

Re: Neratinib Clinical Trial
 

Wow, at least I know I'm not alone. I have my 1 month on the 18th and am very interested to see what my levels are. Will the increase your dose again after some time or will you always stay at the 160mg? I would find it ineresting to see if the body starts to tolerate it. Thanks for sharing Kristy Ann and good luck to you!

Re: Neratinib Clinical Trial
 

Are you allowed to take supplements during this trial? Perhaps a regimine of really good probiotics would help some. I'm not certain of the mechanism of this diarreha, but usually it is caused by an upset of the natural flora of the digestive system.

Re: Neratinib Clinical Trial
 

becuase I have not been eating well during this I tried to take supplements as well as Ensure. Both caused be to vomit which I never did during chemo! I always thought I was pretty tough but this is literally kicking my butt! I will talk to the nurse Monday and see what she says about using pro bi's. I'm a zookeeper and we have several animals under my care on them. Maybe I should see if they want to share.

Re: Neratinib Clinical Trial
 

I also wonder if L-Glutamine would help; it is good for the stomach lining. Ruth took bentonite (clay?) at the early stages of her chemo. It held off the diarreha longer than others however she eventually had to move to some imodium as well.

A zoo keeper! How wonderful!!

Re: Neratinib Clinical Trial
 

...and, is this something causing acidity like chemo does? Ruth would have been lost without her Omprazole during chemo, I wonder if something like this would help.

Re: Neratinib Clinical Trial
 

Im not sure of the mechanism of the diarrhea but nothing I tried could control it. IF you have side effects on neratinib they normally tell you to eliminate dairy as it seems to make everything a lot worse- and that was true for me.

160 mg is great- I had a weekend with no diarrhea this past weekend- first time since I started the trial in early October.

Kriss, There is a protocol for increasing the dosage back if it has been lowered - not sure of the "rules" but my nurse did say they probably would not try that with me because of the severity of the potassium and magnesium problems and their implications.

Kristy

Re: Neratinib Clinical Trial
 

I am watching this thread frequently. Not responding much though.
Kristy, Glad things have settled down. Is that 160 mg per day or twice a day?
Kriss, a zookeeper! Exciting. Maybe the ensure is too rich on an empty stomach. I would be tempted to not eat if the diareha (sp?) were a problem.

I think I would be a good candidate for this trial. At first my onco didn't think I qualified because I am NED. That's a criteria, hello....will know soon. My next appointment is 1-22.

Hang in there all and thanks for reporting.

Love,
Dana

P.S. My hair is now as long as Kriss'. I should learn how to post a new picture...

Re: Neratinib Clinical Trial
 

I take the 160 mg all at once in the morning!

3 normal days in a row- this looks promising!

Kristy

Re: Neratinib Clinical Trial
 

Kristy
Glad things are going better for you. I take 240 mg but I find I have less symptoms if I take them at night. Still have trouble with the diarrhea but nothing like you have had.

Re: Neratinib Clinical Trial
 

I enrolled on Tuesday and am on day three of the pills at the 240 mg dose. First day just a little light-headedness. Audible gurgling in my belly at night. Yesterday a bit of nausea while working out but all seemed like they could be psychosomatic because I so don't want to be in the placebo group.

Day 3, the diarrhea began! Two immodium at onset and another with each loose movement that followed. Not a ton of cramping. Just had dinner and am wondering if I'm in the clear for the rest of tonight. Sure hope so.

Nice to know I'm not alone in this, as always.
xo
cary

Re: Neratinib Clinical Trial
 

Well I'm on day 12 of my resart at 200mg and for the last 2 days my life has been almost normal. Only going to the bathroom 2x a day. Wow. I take my pills at night as well Patty. See the doc on Monday and am interseted to see if they will bump me back up to 240mg. But everyone hang in there and think of all the good we are doing not only for ourselves but for countless others. Have a blessed day!

Re: Neratinib Clinical Trial
 

Took so much immodium on day 3 (when the diarrhea first started) that I was stopped up and bloated day 4.

Day 5 I was back to wishing for diarrhea to get some relief from the unbearable constipation! Careful what you wish for. It started right after dinner last night, but I figured I'd wait to start the immodium in case it was a one time bout. Ha. Had three more "experiences" in the bathroom and took 2 immodium, then one more with the next loose movement and passed out from exhaustion.

It's 2 in the morning on Day 6, and I'm up with that gurgling belly that's been a precursor to the runs each time. I wonder how long I can last on this constipation-diarrhea roller coaster.

I did also get dry heaves and severe hiccups on day 4 when I had the post-immodium-overdose constipation. Almost as if being stopped up on the bottom was forcing it to try to come up instead, but it was too far down my digestive tract.

I wonder if this would be happening if it was delivered via infusion like Herceptin? Maybe oral is just not an ideal pathway?

Terri--you mentioned bentonite clay. How much did Ruth take? I'm gagging at the thought of ingesting that powder, but at 2AM with the gurgling getting louder, I'm desperately eyeing the container in my medicine cabinet. It's labeled for face mask (beauty product) but is pure clay. Perhaps Ruth had it in pill form--that would make more sense.

KristyAnn--any physical symptoms of potassium/magnesium deficiency? or it just shows up on blood work?

Kriss--Looking forward to a report of your appointment this week and the results of the blood work. This is your first blood draw, right?

Re: Neratinib Clinical Trial
 

Thanks to you all for putting up with these side effects. You are bringing hope to the rest of us.
love Ellie