Clinical Drugs Trial

Clinical Drugs Trial

Clinical Drugs Trial

On the day of my diagnosis, after the treatment plan was set, my Consultant Surgeon asked me if I would be interested in taking part in a clinical drugs trial before my surgery.

As we sat there taking all this information of the day in, I sighed and asked her what was involved.  At this point, another two nurses came into the room with clipboards.  They had this air of excitement about them and were clearly trying to suppress it, bless them.

A Breast Cancer study involving several organisations, including Cancer Research UK, was looking at a new drug and the effect it has on Breast Cancer cells.

As I was ‘newly diagnosed’ (erm yes about 3 hours beforehand!) AND I was most likely going to be having Chemotherapy, AND my Cancer fell into all the categories required for the drug to be trialled, AND they needed one more lady to fill their quota for my area… (take a breath) … I could see why they were a little bit excited.

Actually, once they gave me the information on what it was all about, I could understand their excitement and thought “well if you can get something good out of me having this, why not?”

In fact, knowing that I was going to be involved in trialling a drug which in the future could stop cancer cells growing, I felt quite privileged.

What was it all about?

It was called the STAKT trial.  AKT is a protein which helps cancer cells to develop.  Normally cells divide in an orderly way.  Cancer cells divide and multiply faster, because certain proteins which help to control cell growth, behave abnormally.  It is hoped that the development of this drug will provide a new option for cancer treatment.  Something in its early stages of development.

I’d have to have an in-depth assessment to check if I was suitable, to ensure there was nothing else currently or in the past which would interfere with the trial.

I would then be assigned randomly to receive either a higher or lower dose of the drug in tablet form.Cancer Research UK

What would I have to do then?

It sounded quite easy…all I had to do was:

a) Talk with one of the nurses for about 90 minutes about medical history;

Yep no problem with talking for that amount of time;

b) Have a physical, blood and wee tests galore over a series of visits, 3 x ECGs, Pregnancy test

(I’m 43 – no really, there’s no need for that one, love!)

c) Stay in hospital for 7 hours taking tablets, more blood and wee tests, have a side room to myself to sit/lay down, read, sleep, play on the iPad and generally be totally lazy.

Yep I can cope with that too. 

And finally:

d) Go home and take more tablets for 4 days leading up to my operation to remove the tumour.

So, I went away with all this information to read, to ensure I was happy to go ahead with it.

Now initially, it all sounded quite simple.  I didn’t really have to do much.

Let’s Get Going Then!

After a few preliminary fasting blood tests over the next few days, I then went back for the 90 minutes initial assessment. It was so thorough, they literally went over everything.

From childhood illnesses, to operations/hospital stays I’d forgotten I’d had, they literally asked me if I’d ever had any problems with every part of my body!

“Ever had any problems with your ears?”

“Nope”.

“Nothing other than when you stayed in hospital with Benign Positional Vertigo?”

“Oh yeah! Hmm…forgot about that…”

After the assessment ended, a couple of phone calls later, and it had been organised for me to go have the ECGs at the Cardiac unit at the other end of the hospital, and more urgent blood tests in Pathology.

Heart rate was up climbing the stairs – not a good start! But we walked straight into the unit for heart traces and didn’t have to wait long.

Then it was back down to Pathology for the blood tests.  As we walked through the door, there was the usual queue out the door and all seats were taken.  My heart sank thinking I’d have to sit and wait the usual amount of time, which can be half hour or more sometimes.

Instead however, I must have annoyed every single person in the waiting room by strolling on through with my personal nurse, into a cubicle, bloods taken, and escorted back out!

I kept my head down not to make eye contact with the clearly disgruntled few. Sorry people….

Everything was done by the clock.  Bloods had to be taken and processed quickly, systems updated, and forms filled in, oh the forms that nurse completed that day!! She had a folder full of paperwork – I don’t know how she remembered to check everything she checked!

The 7-hour Visit

It was 5 days before my operation, and my Husband dropped me to the hospital about 7.30 am, delivering me to the top floor of the hospital out of the way of the crowds.

Again, I had to fast overnight and once I was in and settled, they tested the blood sugar levels, as one of the main side effects of this drug is raising those levels.

It was then that the lovely scenario of that peaceful day of relaxing, catching up on a bit of sleep, reading some of a book I’d started month’s ago and hadn’t picked up since, and generally lounging about taking the odd tablet, was thrown out of the window.

What ACTUALLY happened that day, was:

  • They had to assess the levels of drug in my bloodstream before and after the first dose and provide blood samples at regular intervals for up to 4 hours;
  • I’d have to wee on demand (not easy when you can’t have gallons of coffee.  Or gallons of water for that matter)
  • Take a tablet, then 2 hours later have more blood tests, then eat a snack, then after another 2 hours take more blood…Clinical Trial Boredom

Then…. then…. they were in and out of my room constantly.  My poor arm gave up giving its blood quickly unfortunately, so they started using the hand.

I got bored VERY quickly.  Especially as there was no Wi-Fi.  Honestly, they really need to prioritise patients’ needs…!

BUT of course, this was all for a good cause and that’s what I had to remember.

What happened after that?

The drug wouldn’t help MY Cancer but could help someone else’s in the future.

Once I’d got home, the drug did have a couple of side effects, but minor really – upset stomach mainly – and that continued for the next 4 days whilst I took the tablets at home.  No allergic reactions to it or unsightly rashes, thankfully.

On the day of the operation, I took the last tablet of the trial and once they removed the tumour, they would compare tissue from it to that of the biopsy of the tumour taken at diagnosis, to see if there was any change in the Cancer cells.

* * *

The only down side to all this (and that’s purely because I’m nosey/impatient/interested – delete accordingly) I won’t get to know if it changed the cells in my tumour.

But I hope to get a general report of how the trial went, once they have finished their research.  This of course can take a few years.

I always knew Cancer research was important.  I always looked at adverts on the TV, but I didn’t really take a huge amount of interest in them.

I now view those adverts a little differently, realising first hand why Cancer research is SO important.

 

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