Re: Neratinib Clinical Trial
 

I am anxious to hear from you in a few days. I didn't have any side effects from the lapatinib at first~
Sandra

Re: Neratinib Clinical Trial
 

I've been puzzled by folks here reporting that their doctors have told them a lack of side effects does not necessarily mean the patient is getting the placebo. If this trial is truly double blinded, then how would the doctors know if the lack of side effects was due to a strong tolerance of the drug or the pill is actually the placebo? I suppose the "placebo effect" acting in reverse could cause someone to experience uncomfortable side effects, but I doubt this happens often. Anyway, I am puzzled by this---

bird

Re: Neratinib Clinical Trial
 

So here is how it's going so far. The day after I took the first dose, I had three bouts of diarrhea. I began taking the immodium and took precautions with my diet. Today, I had only two bouts and still watched my diet according to their recommendations. Now it's been 11 hours and have had no further incidence. Did I just have a stomach virus before? Is the immodium and diet controlling side effects? I don't know. It's just too much of a coincidence to get a stomach virus the day after I started the pills, don't you think? Anyway, we'll see how things develope. But I really don't think this is placebo effect in reverse.

Re: Neratinib Clinical Trial
 

Savta---It sounds like you may very well have been given the Neratinib. Good for you. I doubt those bouts were anything but your GI reacting to the new drug. I wish for you the best success with this, and thank you so much for joining the trial on everyone's behalf.

Good luck---
bird

Re: Neratinib Clinical Trial
 

Hi Ladies and welcome to those of you who are just starting. I am in week 20 and doing great! The diarrhea is still a daily event but every now and then I get a slow day, haha. Savta I was the same as you. The affects started withing the first 18 hours and was wondering if I was just sick or if it was the drug. Hand in there as it does get better or maybe I just tollerate it more knowing I am helping out my sisters. Keep us posted and hope you all are doing well.

Re: Neratinib Clinical Trial
 

Thanks to all of you for words of encouragement. I seem to be into some kind of routine. About every 36 hours I get a really bad bout--but the immodium seems to control it for a while. My biggest problem now is that I am really weak. I don't eat much, because I'm afraid it will bring on the diarrhea again, but I am actually pretty hungry most of the time. I don't seem to be putting much protien in my body, and that may explain the weakness. I mostly eat toast, bananas, applesauce, mashed potatoes and a little clear soup. Any ideas what can give me energy and not get my digestive system too angry?
All in all, I'm doing o.k.--if I could just get pass this weakness and tiredness. Anyone else felt this way?

Re: Neratinib Clinical Trial
 

Savta,
I found that I could eat lean meats OK. The toast, bananas, applesouce, etc. sound like most of my other diet. I did find a "low fiber" diet that also included canned fruits, green beans, and asparagus. I just googled "low fiber diet" and read some of the sources. That helped me a lot. I really had problems if I tried to eat raw veggies, fruits, milk products and whole grain breads. (All of that stuff we normally eat for a healthy diet.) After I completed the year of lapatinib in Nov., I have been catching up on all the things I missed. I also ate more red meat than I usually do because my HGB was so low due to the Taxol and AC. As long as I ate it broiled I did not have problems. My husband said I became "meat and potatoes" girl. I hope this will help you.
Sandra

Re: Neratinib Clinical Trial
 

I just started this trial - took my first dose yesterday morning, around this time, and just took my second dose. I haven't had any side effects yet. Is it too soon, or is it more likely that I am in the placebo group? I do feel a teensy bit crampy, but I'm thinking I am probably just imagining that because I don't really want to be in the placebo group! :)

Re: Neratinib Clinical Trial
 

I don't think it means anything just yet. Some of the women didn't feel anything for the first few days. I also read in Wyeth's website, that 15% of the women taking the drug didn't get diarrhea. Maybe you're in that 15%. Or maybe you are in the placebo group. Keep in mind. No matter what group you're in, you are contributing to the trial. The sooner they get the data, the sooner it gets to the FDA. Then we'll get the benefit.
Good luck--and mainly---stay well!

Re: Neratinib Clinical Trial
 

I too started just yesterday evening and no obvious side effects, yet. Hope it doesn't happen in the middle of ballet class tomorrow! I share the mixed emotions with you all. I never wanted to get diarrhea before, but I might be happy to see it this time!
Regardless, happy to help a trial like this.
Celeste

Re: Neratinib Clinical Trial
 

Well, it's been five days now, and no side effects. I know that not everyone who gets the drug has side effects, but I doubt I am that lucky!

Oh, well, I'm probably on the placebo. That's ok - at least I am helping out, right? :) I feel very lucky to have had a complete response to chemo and to still be NED almost 3 years after being diagnosed, and I am thankful to be able to be part of a trial that might wind up helping a lot of other women in the future.

Of course, I am still holding out hope that the diarrhea starts soon. Haha!

Re: Neratinib Clinical Trial
 

I don't know what to think. I am 13 days into the trial. Had the blessed runs for the first 11 days--now, NOTHING!!! Could it mean that I have already gotten used to the drug? They say it usually takes 2 to 4 weeks. I am going to go back to a regular diet, because now I am sufferring from the opposite!
Like I said, I don't know what to think--so I won't. Every participant is contributing--so I just hope for the best--with or without the drug.

Re: Neratinib Clinical Trial
 

Hi everyone,

Well, I have been on the trial for just over a week now, and still have not experienced any diarrhea. However, I have been feeling very fatigued for the past three days, regardless of the amount of sleep I have gotten. Also, I have been experiencing constipation for the past three days. It's not super bad, but usually I am very regular, and I haven't changed my diet, so I don't know what's going on.

Does anyone know if fatigue and/or constipation are side effects from Neratinib?

How is everyone else doing?

Re: Neratinib Clinical Trial
 

Well, I'm back to feeling the side effects, or what I think are the side effects of Neratinib. I always think I must be used to it by now, and then I have a few rough days. I, too, am much more tired than I used to be. Maybe residual effects of Herceptin? Maybe the havoc in my digestive system? I have my one month check up next week. I hope at least to have lost some weight!!

Re: Neratinib Clinical Trial
 

I am approaching 8 months on the trial and I am definitely on the drug- had to be dose reduced twice to get to a tolerable level. My doc sees the side effects as knowing you are on the real deal but the lack of side effects - she makes no conclusions since some people are lucky and dont have the problems.

I have found eating a cheese stick- mozzarella- daily helps with the diarrhea- doesnt make it go away just less volatile. I avoid dairy except for the small amount of cheese but I have stuck with my regular garden type diet which is pretty high fiber- I do think it causes more problems but I couldnt find what I would want to eat for a year with my garden producing all kinds of good things - so I tough it out. I seem to be in a pattern of having a bad side effect day every 7-10 days- like my body tolerates it as well as it can and then falls apart for a day.

I keep immodium with me and some other small pill you put under your tongue to stop abdominal cramping- use as needed which is only about once per 7-10 days.

I am definitely counting the days until I am finished (Oct 6, 2010 is my last day BTW)

Kristy

Re: Neratinib Clinical Trial
 

Tomorrow is my one month check up. For the last week, the diarrhea and just plain lousy feeling have accelerated. I seem to have "bad" bouts every day--and giving in to popping Immodium. I am curious as to how tomorrow's blood work is going to go. But, I am having a rough time coping. I keep telling myself how lucky I am to be in the study, and apparantly receive the real thing--but, eleven months is also a long way away. I'm wondering when my body will adjust, as was promised.

Re: Neratinib Clinical Trial
 

I have wanted to join this trial since last summer when my oncologist first told me it would be available after I finished with my TCH regimen this July. But I won't get the chance. I unfortunately learned yesterday from his trials nurse that my gender makes me ineligible. I will have to find some other way to get exposure to a tyrosine kinase inhibitor like Neratinib. Perhaps there is a CAM regimen that would help.

Despite this set back, I am grateful to all the ladies who have signed up for the trial and by their efforts will advance the knowledge base for treating Her2 BC.

bird

Re: Neratinib Clinical Trial
 

So here I am, six weeks into the trial. I still get really bad bouts of diarrhea, and feel weak and queasy--but I do get a few good days in between the lousy ones. I still don't know what is good to eat--and I keep trying new ideas--so thanks for all the suggestions. I was feeling really out of shape, so I decided to go back to taking multivitamins, and I joined a gym. I go three times a week, and even on the bad days, it picks me up. Whatever works, right? In addition, my physiotherapist said that exercise in water is really good for the mild lymphedema. So I get that in too. It's all about staying well.

Re: Neratinib Clinical Trial
 

Hello everyone - just want to say how useful it has been to read all your comments. I live in Madrid, Spain and have been selected for this trial here. I started on Thursday after all the usual tests. It has been particularly good to read about it all in English! My Spanish isn't bad, but when its so serious, you want to check things out in your own language - well, I did anyway! I couldn't find any info in England - so you all over there are helping!
I had diarrhea the second day, so I guess I am taking the real thing, which is actually good to know!
I also signed another agreement on Thursday to release my biopsy tissue samples for genetic testing - I apparently have the right to see the results, so that is a very interesting side issue.

Re: Neratinib Clinical Trial
 

Well, just got back from my 6 month check in and am told I have to go off the drug. Blood work and Ekg are great but my muga dropped from 68 to 42. Protocol says off drug for 3 weeks then redo the muga if I am not above 50 then I am off for good even if it went to 49. Anyone else out there drop that much? I only went down 17 point during all of herceptin and went back up right away. Hoping this time it will as well. At least I will get a rest from the diarreha! Keeping you all in my thoughts.