Don’t really know what im asking here, tbh I think I’m just looking for questions to ask? And wanting to get a bit more info.

Anyway, my mum has been asked if she would like to take part in a trial of a drug called sorafenib, a cancer drug. It’s a double blind test, with 3 groups, one gets a placebo and the other 2 groups get the drug for 1 and 3 years respectively. And would need to carry the trial on for 8 years.

A wee bit of background, she was recently diagnosed with kidney cancer and had the op to take the kidney, which all went amazingly well, and she is almost completely recovered from the surgery, with docs saying that her cancer gone.

And essentially that is the point of the trial, is that they are looking for people recently recovered from cancer, that could possibly have a few cells that have escaped to see what effect it has on these people. Apparently the drug has had success in more serious cancers and has reduced tumors. So they want to see if it can have any use before things get so serious.

Anyway, I’d appreciate any thoughts or knowledge people have on this subject or drug, and indeed thoughts on medical trials in general.

My mum is fairly unsure what she wants to do, she’d like to help but some of the possible side effects sound quite grim, and tbh it is an extremely long trial.

Cheers for any input.

Well, if no one ever volunteered to try anything new, nothing would ever advance! If she does decide to participate, she might take some satisfaction in that she’s helped improve treatment for others in the future.

And I’m sure that she would have to be able to stop the trial at any time if she wanted to. Obviously, they want and need a sufficient number of people to run through the whole trial, but there is no way that they can force her to continue with it if she does not want to.

Other than what the potential side effects are, my big question would be about what dosage of medication she would be taking and how that compares to the dosages used in other treatments. Side effects often are worse with higher dosages, so if a low dose, I’d be more willing to participate. For instance, if the study dose is 1/100 of the dose used to treat the more aggressive cancers, I would consider participating. If it was a high dose with bad side effects, I’d be less likely to get involved.

Just my 2 cents and I’m not any sort of medical type at all.

There’s really 3 flavours of trials- new things that are more or less untested, things that have been tested elsewhere but not yet approved here, and things that are approved for other uses and are being tested for new purposes.

I’ve done one each of the last 2, and tbh it takes most of the guesswork out of it, it’s possible to do some independant reading. And I have to say that I never found any obvious bias in the trial documentation, though I think a healthily paranoid attitude’s still wise.

Very quick google suggests this is a fairly trusted drug, with a possible link to some conditions which are treatable but reversable.

But it’s a personal choice… I’m alive today because some other poor sods took the plunge about a hundred years ago (*), so I suppose I’m quite open to it but I don’t think anyone can be faulted for saying no.

(*- though, said poor sods would have carked it anyway so maybe it’s not so brave!)

As long as it doesn’t interfere with any other drug regimens (which the docs would know about anyway) then I’d say do it.

Even if she can’t stand the drug and comes off it after a few months then that will guide researchers and clinicians towards having an idea of the tolerability of the drug for that use. All data is good data, even patients showing sides that have to quit. Eg what are the causes of those sides? How can we reduce them, do they affect people in certain groups etc?

One of the often overlooked benefits is that patients often get monitored more closely when they are on trials – something that’s clearly a benefit in a scenario like this.

My advice would be to have a conversation with the doctor about how being on the study could affect her current treatments.

Also, the doctor will not just blindly follow the study program – if it’s not in your mum’s best interest to continue, they’ll take her off the study and do whatever is best for her.

Hope all goes well!

Cheers all, thanks. My thinking is fairly similar to you all tbh, I’ve read through the document supplied, which is fairly in-depth. So I’ve a fair idea of how it’ll all run, really is just a case of balancing it all up and then making a decision. Personally I think if it was me, I’d go for it, but I’m not a 60 year old that has just recovered from a cancer heading towards retirement. She really has to be comfortable doing it, that’s my main concern tbh.

so far i’m at:

Positives:
-Will be more closely monitored.
-If the cancer does return, it’s possible that this treatment could prevent that from happening.
-Get to help out in something that could be really worth while.

Negatives:
-Having to attend the hospital more(although, she’ll be attending -regularly for 5 years anyway, plus it’s not necessarily a bad thing, depends how you look at it I suppose).
-Possible side effects.

First off, my advice to her is to make sure she is 100% comfortable in taking part, if there’s any doubt she should decline, as I don’t want her feeling she is obligated(the document does point out that she isn’t, that is made fairly clear).

But if she is happy with that then, it’s really a case looking at the side effects and if she is willing to take that risk(document says 1% can get a severe reaction, and 15%-30% will get some sort of reaction).

If she then thinks it’s an acceptable risk, then to go for it.

Her next port of call is to speak to her GP firstly, and then she’s got a CT scan the week after, so to speak to her doctors there about it too. After that, I think she should be in a good position to make a decision.

If you discount the monitoring of her condition more closely as a negative then the only negative is side effects.

Unless any of these are severe (in which case she could stop taking the drug) then it’s surely worth taking part?

She has a 1 in 3 chance of taking a placebo anyway so the additional monitoring may be welcome?

Start this post by stating that this is my job, I develop medicines, so you may wish to ignore me if you think that makes me biased.

By the time the drug has got to the stage where it can be tested on people with the target condition i.e. your mum, it has been tested on humans several times, so side effects will hopefully be known and by this stage, minimal. However, the trials to-date will have tested in fairly small numbers so not every possible side-effect may have happened, NB thalidomide.

By partaking in the study, your mum will get the best care available, and far closer monitoring than usual, which can only be a good thing.

Also, it is unethical (i.e. strcitly forbidden by the government) to withdraw the current best treatment to properly test the new medicine’s effect on its own. This means that not only will your mum receive the best available treatment currently on the NHS, but she will also (if she is not given the placebo!!) receive this new medicine in addition. So in terms of treatment this also will hopefully be beneficial.

I hope this helps.

My mum has had cancer in several places for the past two years. I always hoped there might be a trial she could get on as I think it is a good thing. But sadly there has not been one offered yet.

I wanted to jump in on this. First a bit of background – I’m a medical writer and one of the areas I cover is oncology, including renal cell carcinoma. I’m not going to offer comment on the effectiveness of sorafenib as I haven’t seen much detailed data on it (only in the context of it vs my clients agent’s data).

What I recently picked up was interesting – I was covering a meeting where a quite well known (in these circles) speaker was giving a keynote lecture on maximising outcomes in treatment of mRCC through good management.

One of her take home messages was that some of the side effects can be effectively managed by prophylaxis and proper care, and doing so can extend the time and dose of treatment, thus possibly improving outcome. So for sorafenib, things like diarrhea can be managed (she recommended either loperamide and or 2 grated apples (she has found the pectin helps bind it all together); similarly hand foot syndrome (which is a skin reaction) can be managed by a pedicure before treatment and then use of creams and soft insoles. She should maybe discuss things like this with the clinicians running the trial as it might increase chances of remaining on the trial for longer if she does go ahead. Good luck to her!

I’m a medical writer and one of the areas I cover is oncology, including renal cell carcinoma

I love stw.

Doesn’t matter what the subject is there’s always genuinely knowledgeable people willing to help.

I love stw.

Doesn’t matter what the subject is there’s always genuinely knowledgeable people willing to help.

Tis quite amazing…

thanks again people, not really wanting to jump in too much myself, as my knowledge is limited, so please, discuss away. Very interesting reading for myself.