presently in B Raf trial / side effects?

I am SO sorry to hear you are having such a hard time with side effects. I remember how excited you were a few weeks back with getting on this trial. 

I really, really hope that the symptoms can be better controlled. Have your doctors even tried to control some of your side effects? I would think your doctors would be quite concerned about the fact you aren't eating!

And they can't improve your foot soreness at all? 

Hoping for better times for you!

Michelle, wife of Don

I am SO sorry to hear you are having such a hard time with side effects. I remember how excited you were a few weeks back with getting on this trial. 

I really, really hope that the symptoms can be better controlled. Have your doctors even tried to control some of your side effects? I would think your doctors would be quite concerned about the fact you aren't eating!

And they can't improve your foot soreness at all? 

Hoping for better times for you!

Michelle, wife of Don

Thanks Michelle 🙂 Well, I saw the trial team yesterday, and all that accompllished was much frustration and the inability to walk for the next few days at least- their only suggestion for the foot pain was endone, and lots of it. I'm sorry?!?!! Yup. Take lots of drugs that make you drowsy and ditzy. That will work well with a 6 year old! From what I can gather, the results of the scans are ALL that matter to these people. I'm left with a last resort of emailing the head of the team to get some satisfaction. No, I don't want to die sooner than I have to, but if this is the BEST they can do to manage these side effects, then I'll drop out of the trial

I had my mother with me this visit. She's distraught- not at the thought of me dropping out of the trial, but at my having to live like this. She said "They just don't want to even know about how shocking this is for you, they just want to be able to say their drug works.- They don't even care about the patient." (And then she swore a lot- unusual for Mum!)

Maybe I'd get some resolution and decent suggestions if I weren't simply passed off to different registrars at each visit. This one seems to at least want to do something, but I was left with the distinct impression she's not at liberty to reduce the dosage or even have a break for a few weeks (GSK might not let us reduce the dose or allow you to have a break on it- excuse me?!!? WHo is the bloody patient here?) So as you can see, no satisfaction at all.

Wish me luck with the email. I'll take some time putting it all together and hopefully get it sent off today. HE seems a caring type and concerned about QOL, but the rest of his crew? Not so much. They just want the numbers to look good. *sigh*

Hope all going well with yourself and Don!!?

Nic

Thanks Michelle 🙂 Well, I saw the trial team yesterday, and all that accompllished was much frustration and the inability to walk for the next few days at least- their only suggestion for the foot pain was endone, and lots of it. I'm sorry?!?!! Yup. Take lots of drugs that make you drowsy and ditzy. That will work well with a 6 year old! From what I can gather, the results of the scans are ALL that matter to these people. I'm left with a last resort of emailing the head of the team to get some satisfaction. No, I don't want to die sooner than I have to, but if this is the BEST they can do to manage these side effects, then I'll drop out of the trial

I had my mother with me this visit. She's distraught- not at the thought of me dropping out of the trial, but at my having to live like this. She said "They just don't want to even know about how shocking this is for you, they just want to be able to say their drug works.- They don't even care about the patient." (And then she swore a lot- unusual for Mum!)

Maybe I'd get some resolution and decent suggestions if I weren't simply passed off to different registrars at each visit. This one seems to at least want to do something, but I was left with the distinct impression she's not at liberty to reduce the dosage or even have a break for a few weeks (GSK might not let us reduce the dose or allow you to have a break on it- excuse me?!!? WHo is the bloody patient here?) So as you can see, no satisfaction at all.

Wish me luck with the email. I'll take some time putting it all together and hopefully get it sent off today. HE seems a caring type and concerned about QOL, but the rest of his crew? Not so much. They just want the numbers to look good. *sigh*

Hope all going well with yourself and Don!!?

Nic

John, unfortunately it's not about exercise, it's about being unable to walk because of the pain. You know, walk to get the mail. Walk your child into the school gate… stand on your feet and cook meals, shop for groceries. Those sort of things. I've bought disgustingly expensive shoes, and inner soles to help the matter, ultimately they feel ok on my feet, until I actually stand on them and walk.

Really, it's the faitgue and the feet. Everything else is a "nothing" for me on the importance/issue scale of the side effects. If they would just do something about the feet, I could do my own thing to help with the fatigue (that's where the exercise comes in, and really- I HATE swimming. Always have. I can do it, but it would be a chore and I'd not likely not continue it)

My motto since this all began has been "quality time with Georgia". Without that, I don't see the point. This is compounded by knowing that resistance is likely in the near future, and knowing that giving myself a few months simply in order to be breathing doesn't make any sense to me at all. I had a far better quality of life when I was literally having my head cracked open and my tumours scooped out every 2 months.

To be  complaining about sore feet probably sounds ridiculous to some people , but I don't care. It is bloody agonising and debilitating, and further compunded by the lack of the docs to address it. Of all the STUPID things to make someone want to discontnue a study drug that is currently working!?!!

They were concerned about my weight loss. I said, "I. Don't. %#@*ing. Care. About. That. It doesn't affect my quality of life. I've done chemos before. Nausea may irritate me occasionally, but it doesn't make me want to take these tablets and throw them in the bin. The effects of the foot pain on my life, DO!"

I just think that surely, the fact that this foot pain is wanting me to either break from, or have the drug reduced (or quit), knowing what that may result in, must surely indicate to them how bad things are and make it important that they address it?

Anyway, off to compose and send off an email to the head doc, and cross my fingers that it won't be a complete waste of time. (I think I can be contacted via the MRF contact email through my profile.)

Cheers,

Nic

John, unfortunately it's not about exercise, it's about being unable to walk because of the pain. You know, walk to get the mail. Walk your child into the school gate… stand on your feet and cook meals, shop for groceries. Those sort of things. I've bought disgustingly expensive shoes, and inner soles to help the matter, ultimately they feel ok on my feet, until I actually stand on them and walk.

Really, it's the faitgue and the feet. Everything else is a "nothing" for me on the importance/issue scale of the side effects. If they would just do something about the feet, I could do my own thing to help with the fatigue (that's where the exercise comes in, and really- I HATE swimming. Always have. I can do it, but it would be a chore and I'd not likely not continue it)

My motto since this all began has been "quality time with Georgia". Without that, I don't see the point. This is compounded by knowing that resistance is likely in the near future, and knowing that giving myself a few months simply in order to be breathing doesn't make any sense to me at all. I had a far better quality of life when I was literally having my head cracked open and my tumours scooped out every 2 months.

To be  complaining about sore feet probably sounds ridiculous to some people , but I don't care. It is bloody agonising and debilitating, and further compunded by the lack of the docs to address it. Of all the STUPID things to make someone want to discontnue a study drug that is currently working!?!!

They were concerned about my weight loss. I said, "I. Don't. %#@*ing. Care. About. That. It doesn't affect my quality of life. I've done chemos before. Nausea may irritate me occasionally, but it doesn't make me want to take these tablets and throw them in the bin. The effects of the foot pain on my life, DO!"

I just think that surely, the fact that this foot pain is wanting me to either break from, or have the drug reduced (or quit), knowing what that may result in, must surely indicate to them how bad things are and make it important that they address it?

Anyway, off to compose and send off an email to the head doc, and cross my fingers that it won't be a complete waste of time. (I think I can be contacted via the MRF contact email through my profile.)

Cheers,

Nic

Nic, is this foot pain anything like neuropathy? And is it reversible?  I ask because some of the chemo things Grayum did resulted in neuropathy in his feet, and it was awful. Hope it subsides for you!

Nic, is this foot pain anything like neuropathy? And is it reversible?  I ask because some of the chemo things Grayum did resulted in neuropathy in his feet, and it was awful. Hope it subsides for you!

Nic –

I am sorry to hear that the drugs are giving you such a hard time.  Being on the same trial I can sympathies with you.   I share your fears about it losing it's effectiveness especially since I am about a month further into this than you are.    I have had all the same side – effects although it doesn't sound like they are anywhere near as severe.  They defiantly come and go and seem to get somewhat better as time goes on.   I have had many discussions on these with my onc.  (they can make you nuts I know)  Theory is that the worse the tumor burden the worse the side effects especially the fevers – thankfully mine is quite minimal so supposedly that is why not as bad.  Might I suggest you trying to get a script for Celebrex – I got one from my onc. because the joint pain would get so bad sometimes that I was in your boat having a hard time walking and the bottom of my feet where always hurting.  Celebrex seems to help quite a bit.

Hang in there Nic – I need all of my BRAF/MEK friends.   I too have a 6 and 8 yr old and when I feel like sh**  they are what keep me going, and I know that Georgia does that for you.  It's working for now and hopefully will continue to do so, Ride the train as long as you can.     Let me know how it goes.

 

Hugs and Smiles

Dawn

Nic –

I am sorry to hear that the drugs are giving you such a hard time.  Being on the same trial I can sympathies with you.   I share your fears about it losing it's effectiveness especially since I am about a month further into this than you are.    I have had all the same side – effects although it doesn't sound like they are anywhere near as severe.  They defiantly come and go and seem to get somewhat better as time goes on.   I have had many discussions on these with my onc.  (they can make you nuts I know)  Theory is that the worse the tumor burden the worse the side effects especially the fevers – thankfully mine is quite minimal so supposedly that is why not as bad.  Might I suggest you trying to get a script for Celebrex – I got one from my onc. because the joint pain would get so bad sometimes that I was in your boat having a hard time walking and the bottom of my feet where always hurting.  Celebrex seems to help quite a bit.

Hang in there Nic – I need all of my BRAF/MEK friends.   I too have a 6 and 8 yr old and when I feel like sh**  they are what keep me going, and I know that Georgia does that for you.  It's working for now and hopefully will continue to do so, Ride the train as long as you can.     Let me know how it goes.

 

Hugs and Smiles

Dawn

Thanks Dawn 🙂

Most of my symptoms have been increasing with time, and appeared a couple of weeks ago, and by that point the tumour burden was nothing compared to what it was previously. The feet I've had since day 2 or 3 (so for the past 3 months), progressively getting worse over time. I am just over them not listening at all about the feet. Thanks for the celebrex tip. Are you on BRAF or BRAF/MEK? Rumour has it the BRAF/MEK side effects are a little less severe… BUT, as we all know, different people have different symptoms and degrees 🙂 Anyhoo, I'd better see a change in attitude. In order to help that along, I think I will be sending an email outlining my dissatisfaction shortly. If I didn't need an onc to be on the trial, I wouldn't have one. I'm not a fan of onc's.

I'm still on the train. Been on the horrible rickety thing for 3 years now. Time for a seat in first class, dammit!! (Or a wheelchair :P) Economy bites 😀

Take care, hope things stay good for you for a long time to come!!

Cheers,

Nic

Thanks Dawn 🙂

Most of my symptoms have been increasing with time, and appeared a couple of weeks ago, and by that point the tumour burden was nothing compared to what it was previously. The feet I've had since day 2 or 3 (so for the past 3 months), progressively getting worse over time. I am just over them not listening at all about the feet. Thanks for the celebrex tip. Are you on BRAF or BRAF/MEK? Rumour has it the BRAF/MEK side effects are a little less severe… BUT, as we all know, different people have different symptoms and degrees 🙂 Anyhoo, I'd better see a change in attitude. In order to help that along, I think I will be sending an email outlining my dissatisfaction shortly. If I didn't need an onc to be on the trial, I wouldn't have one. I'm not a fan of onc's.

I'm still on the train. Been on the horrible rickety thing for 3 years now. Time for a seat in first class, dammit!! (Or a wheelchair :P) Economy bites 😀

Take care, hope things stay good for you for a long time to come!!

Cheers,

Nic

Hi Nic

 

I am BRAF/MEK and your right the side effects are not as bad but they definetly have there moments – especially when I "over" do it.  To bad you don't have a MEK arm, you would feel much better.   Mine didn't care much about my feet either(doesn't listen about much really) and thankfully it wasn't as bad as yours or I would have been just as annoyed.  It sucks when you have difficulty walking.

 

Hugs and Smiles

Dawn

Hi Nic

 

I am BRAF/MEK and your right the side effects are not as bad but they definetly have there moments – especially when I "over" do it.  To bad you don't have a MEK arm, you would feel much better.   Mine didn't care much about my feet either(doesn't listen about much really) and thankfully it wasn't as bad as yours or I would have been just as annoyed.  It sucks when you have difficulty walking.

 

Hugs and Smiles

Dawn

Hey Nic

 

I had another thought –  if you haven't already ask if they can go to GSK and randomize you to the combo.  If you are truly thinking about leaving the trial due to QOL they be motivated to do so.   I know that when I was being randomized my onc told me that if I got one or the other and it didn't work they would go back to GSK and ask for the COMBO.   It's worth a try because I really think that you would feel better.

I hope it works out for you.

Dawn

Hey Nic

 

I had another thought –  if you haven't already ask if they can go to GSK and randomize you to the combo.  If you are truly thinking about leaving the trial due to QOL they be motivated to do so.   I know that when I was being randomized my onc told me that if I got one or the other and it didn't work they would go back to GSK and ask for the COMBO.   It's worth a try because I really think that you would feel better.

I hope it works out for you.

Dawn

I'm sure they do have their moments, Dawn. None of expect to get out of any treatment scott free from side effects. I certainly don't. I'm just long past the point of where I deal with people who don't listen 🙂 Been there done that a few years ago, and have no intention of going throught the angst and annoyance ever again. Fired my first neurosurgeon after first consult, and fired my last oncologist too. If you're not helping guys, you're part of the problem! Can I please go back to having bi-monthly craniotomies? At least I had fun with those docs and felt better after having surgery 😛 Maybe I'm having general anaesthetic withdrawls or something? 😉 "My Kingdom for a brain surgery!"

Nic 😀

I'm sure they do have their moments, Dawn. None of expect to get out of any treatment scott free from side effects. I certainly don't. I'm just long past the point of where I deal with people who don't listen 🙂 Been there done that a few years ago, and have no intention of going throught the angst and annoyance ever again. Fired my first neurosurgeon after first consult, and fired my last oncologist too. If you're not helping guys, you're part of the problem! Can I please go back to having bi-monthly craniotomies? At least I had fun with those docs and felt better after having surgery 😛 Maybe I'm having general anaesthetic withdrawls or something? 😉 "My Kingdom for a brain surgery!"

Nic 😀

Sorry- I didn't know how to answer your question LV, having had no experience with it, and the time I mentioned it to the trial team, they firmly told me it was definitely due to the excess growths of skin on the feet/calluses.

Now, however, I have had sweet, SWEET vindication! Not through the trial team, but through my own fantastic GP. They may have refused to listen, but fortunately for me, I have other people on my CHOSEN care team who aren't so blase and useless.

HE came and visited me at home on his day off, talked with me about the pain, listened to my description, and performed a rudimentary nerve conduction test. Guess what? It was indicative of peripheral neuropathy. THEN we discussed was type of drug were and were not disallowed while on the study, then he called the trial team and discussed his results and what he wanted to prescribe.

The following day after work, he performed another home visit, supplied me with a medication from his sample packs and talked me through the treatment program. There was a noticeable improvement within 12 hours (overnight).

This unethical treatment by the trial team, is disgraceful. Patient care should not be neglected because a patient is on a study. And for it to be necessary to receive standard patient care from outside the trial, should stun me, but very little about oncology surpises me or fills me with confidence. It's a crying shame one has to be involved with oncology in order to be on a trial.

But really, how bloody hard should it be for a trial team simply to listen to a patient? Just the reduction in the chronic pain has had a greater effect than just my feet. Fatigue has improved- amazing how being able to walk can assist in that 😛 The other side effects, as I've said, I have no issue with.

Sorry- I didn't know how to answer your question LV, having had no experience with it, and the time I mentioned it to the trial team, they firmly told me it was definitely due to the excess growths of skin on the feet/calluses.

Now, however, I have had sweet, SWEET vindication! Not through the trial team, but through my own fantastic GP. They may have refused to listen, but fortunately for me, I have other people on my CHOSEN care team who aren't so blase and useless.

HE came and visited me at home on his day off, talked with me about the pain, listened to my description, and performed a rudimentary nerve conduction test. Guess what? It was indicative of peripheral neuropathy. THEN we discussed was type of drug were and were not disallowed while on the study, then he called the trial team and discussed his results and what he wanted to prescribe.

The following day after work, he performed another home visit, supplied me with a medication from his sample packs and talked me through the treatment program. There was a noticeable improvement within 12 hours (overnight).

This unethical treatment by the trial team, is disgraceful. Patient care should not be neglected because a patient is on a study. And for it to be necessary to receive standard patient care from outside the trial, should stun me, but very little about oncology surpises me or fills me with confidence. It's a crying shame one has to be involved with oncology in order to be on a trial.

But really, how bloody hard should it be for a trial team simply to listen to a patient? Just the reduction in the chronic pain has had a greater effect than just my feet. Fatigue has improved- amazing how being able to walk can assist in that 😛 The other side effects, as I've said, I have no issue with.

I just glanced and read about sore feet my husband has been on it he’s on cycle 5 and has been complaining about sore feet his docs said they haven’t heard about it and wrote it off to weight loss and calluses on feet gave him a cream. So I find it interesting you said the same thing. His other side effects have been skin tags those sqemush (spent wrong I’m sure) cells bad acne, very dry skin joint aches, finger tips numb. In beginning he had violent shakes with fever and chills along with hair shedding really bad. His scans he had a month ago did show that two tumors shrank 1cm. Compared to il2 this has been much easier on him.

Ps he’s on gsk braf (food particle study) not combo with the mek

Ps he’s on gsk braf (food particle study) not combo with the mek

Ps he’s on gsk braf (food particle study) not combo with the mek

Ps he’s on gsk braf (food particle study) not combo with the mek

Ps he’s on gsk braf (food particle study) not combo with the mek

Ps he’s on gsk braf (food particle study) not combo with the mek

Ps he’s on gsk braf (food particle study) not combo with the mek

Ps he’s on gsk braf (food particle study) not combo with the mek

Hi Drea,

Combining the comments about the feet and the finger tip numbness, I'd be asking them to do a nerve conduction test to rule out neuropathy. I'm sure pretty much everything is easier on people than IL-2… but that doesn't mean their symptoms and side effects should not be addressed. Reporting side effects is supposed to be a requirement under the ICHGCP, which trials are supposed to adhere to. And the companies provide guidelines as to the reporting of AE's and SAE's.

Oncologists treat their trial drug like their babies if it's addressing the disease to their satisfacation. They just don't want anyone, even a patient, to point out that it is causing them problems. Unfortunately, this is how some drugs get to the marketing stage, only to find that side effects which were never mentioned before, start popping up everywhere. For some side effects, it's not life threatening, (and the feet, though debilitating, isn't). But I can certainly remember certain drugs being removed from the market because of 'unexpected' life threatening side effects/reactions. They need to grow up, harden up, and start reporting side effects correctly- they are meant to be scientific, aren't they?

I had a fantastic investigator when I began working in trials- he listened. Unfortunately he moved on, and I was forced to run trials with an utter, ignorant wanker. He tried to argue that some side effects weren't related to study drugs, but as I told him. "We report every adverse event. Then if you tick the box that indicates you don't think it's related to study drug, I don't care. But we always report AE's. It is a requirement to report them to the company AND to notify the ethics committee."

It turned out once, as we only had 5 patients on a particular study for a rare issue, that one of them developed osteonecrosis. Upon talking with other coordinators at a meeting, there were many other instances of osteonecrosis, but as they only had small study numbers, none of the investigators had considered it as related to study drug. It is now a known side effect of this particular drug, and monitored for it to minimise the impact.

Unexpected side effects occur. It's a fact of life. I also recall a drug for rheumatoid arthritis causing "ruptured archilles tendons" when I was still working. If it hadn't happened to 3 patients within a short space of time, one would have thought it ridiculous to even consider that it may be a side effect of the drug. (Sorry for the rant- as you can probably tell, it's a real bug bear or mine *blush*) At least by reporting correctly, even if someone develops the side effect, they are monitoring for it, and hopefully able to address it/diagnose it more quickly.

Hi Drea,

Combining the comments about the feet and the finger tip numbness, I'd be asking them to do a nerve conduction test to rule out neuropathy. I'm sure pretty much everything is easier on people than IL-2… but that doesn't mean their symptoms and side effects should not be addressed. Reporting side effects is supposed to be a requirement under the ICHGCP, which trials are supposed to adhere to. And the companies provide guidelines as to the reporting of AE's and SAE's.

Oncologists treat their trial drug like their babies if it's addressing the disease to their satisfacation. They just don't want anyone, even a patient, to point out that it is causing them problems. Unfortunately, this is how some drugs get to the marketing stage, only to find that side effects which were never mentioned before, start popping up everywhere. For some side effects, it's not life threatening, (and the feet, though debilitating, isn't). But I can certainly remember certain drugs being removed from the market because of 'unexpected' life threatening side effects/reactions. They need to grow up, harden up, and start reporting side effects correctly- they are meant to be scientific, aren't they?

I had a fantastic investigator when I began working in trials- he listened. Unfortunately he moved on, and I was forced to run trials with an utter, ignorant wanker. He tried to argue that some side effects weren't related to study drugs, but as I told him. "We report every adverse event. Then if you tick the box that indicates you don't think it's related to study drug, I don't care. But we always report AE's. It is a requirement to report them to the company AND to notify the ethics committee."

It turned out once, as we only had 5 patients on a particular study for a rare issue, that one of them developed osteonecrosis. Upon talking with other coordinators at a meeting, there were many other instances of osteonecrosis, but as they only had small study numbers, none of the investigators had considered it as related to study drug. It is now a known side effect of this particular drug, and monitored for it to minimise the impact.

Unexpected side effects occur. It's a fact of life. I also recall a drug for rheumatoid arthritis causing "ruptured archilles tendons" when I was still working. If it hadn't happened to 3 patients within a short space of time, one would have thought it ridiculous to even consider that it may be a side effect of the drug. (Sorry for the rant- as you can probably tell, it's a real bug bear or mine *blush*) At least by reporting correctly, even if someone develops the side effect, they are monitoring for it, and hopefully able to address it/diagnose it more quickly.

I just glanced and read about sore feet my husband has been on it he’s on cycle 5 and has been complaining about sore feet his docs said they haven’t heard about it and wrote it off to weight loss and calluses on feet gave him a cream. So I find it interesting you said the same thing. His other side effects have been skin tags those sqemush (spent wrong I’m sure) cells bad acne, very dry skin joint aches, finger tips numb. In beginning he had violent shakes with fever and chills along with hair shedding really bad. His scans he had a month ago did show that two tumors shrank 1cm. Compared to il2 this has been much easier on him.