Clinical Trials

My first experience was slightly, a slight disaster. Well, what happened was that they took my blood pressure and it was over 200, so I was in the right place. They then gave me a medication, 50mg of atenotol [atenolol] I think it was. And that was all right. And then after two or three weeks, after I’d been up there two or three times, they put me onto 100. And I woke up one morning, I thought I was having a stroke, like bands of steel round your chest, I couldn’t breathe. I thought, “Well, this is how people feel when they’re going to die” you know. So I got up and I pottered about and I thought, “Well, I’ll tidy the place up”, you know. I like to if somebody comes in. And I couldn’t think what to do. And I sat by the street door in a chair, because I thought, “Well, if I fall off the chair, somebody will see that I’m not very well.” Anyway after about half an hour it went, disappeared. So I thought, “Well, that’s, that is, that’s useful.” So I phoned ASCOT and told them about it and she said would I come up right away? So I went up there. And he, I didn’t see the same doctor that had gave me the pills, but he had a look and he said, “Well, I see you had been on 50. You went onto 100 and then you had the trouble?” And I said, “Yes.” He said, “Well, I’ll put you back on 50”, which seemed reasonable at the time. Except that once you’ve been primed with 100 and you went back to anything below it, you got 50 per cent of the reaction that you did with 100. So I, I got the same thing back again. But I thought, so I don’t know if they were a lot of apprentices up there, but they should have known about that. They should, it wasn’t a new drug, it was an old drug - unless he was trying to do something for his statistics. And I was so annoyed about it, I never went back. I thought they should have known about that. That is something I thought they should have known about. I couldn’t expect them to know that it would affect me adversely, because I’d never taken it. But once I had taken it and the pattern begin to emerge I thought he would have said. I saw it, and I don’t know nothing about medicine. Anyway I never went back.

 

Then I got a phone call. I think it was from [doctor] enquiring why I hadn’t turned up. So I explained to him what I’ve just explained. And I just had no choice other to explain it completely. No watchwords. Just tell it exactly how it happened. I said, “And quite frankly” I said, “I was a little bit alarmed about it.” I said, “Because if you look at it, I’ve come to see you quite well and finished up in a sort of personal disaster.” Anyway he explained it to me. Over an hour he was on the phone. And I was determined not to go back. But he was so, he was like he was treating me like I was somebody rare. So I thought, “Well, I must honour his concern for my welfare.” So I went back again. And he put me on another medication, that I took right the way through all the years I was in there. And it worked. So I was glad I went back. So the important thing with this is that if you go on one of these long projects, these clinical trials, don’t be discouraged if something goes wrong. Because it’s the overall picture that counts.

 

FOOTNOTE' It is important to report any side effects promptly, as this tells the researchers something important. They may be able to help manage the side effects, or advise you whether you should stop taking part. Withdrawing from a trial because of side effects is entirely reasonable and no-one should feel they have to stay in for the sake of the trial or that they have failed if they stop.

I didn’t realise what it was involved in all this, because I had to inject myself, into my stomach, which I found quite a pain, because I had never injected myself before, as a lot of other people haven’t, obviously. There was - yes, so I was having to do that morning and evening to start with, twice a day, then it went on for quite a few months. I was prepared to do it so long as - then something happened in my life, a very close relative was in hospital. The smell of this - I didn’t know if it was a placebo, nobody told me if it was the real thing or a placebo, but I was pretty sure it was the real thing because it just smelt different - I just found I couldn’t do it any longer.

 

Oh, they were very good about it. They’re probably used to people giving up on these things.

 

There must be lots of reasons why, but I thought this was a - I know I was not that keen on it in the end, anyway, to say the least. But that was really the deciding factor was having a member of the family very ill and having to smell the hosp- - I know even working in the hospital you get used to it, but it’s just on a different level smelling this. It’s terrible. It’s just making my mouth dry and my stomach wobble.

And they asked me if I’d like to go into this trial where I would either have the, what they considered the normal treatment of every day for a month, or every day for two and a half weeks, except for at weekends, of course. And [coughs] it would be, you would have no choice. It would be - what’s the word? I’ve forgotten.

 

 

Randomised, that’s it. It’d be randomised so that I would be in one or the other. Of course, I was hoping I’d be in the two and a half days [weeks], but unfortunately I was in the full month. Previously, the consultant had said to me that some centres use the two and a half weeks as their normal standard treatment, and it did occur to me that perhaps I could drop out of the trial at two and a half weeks, and then I, you know, I’d get what I wanted [laughs]. But I didn’t do that. I carried on and had the whole lot.

 

Now, I do regret it now that I didn’t stop at two and a half weeks, because I’ve discovered since that my lymphoma is extremely sensitive to radiotherapy, because I got trouble with my salivary glands last year, and they swelled up, and they discovered there was lymphoma in them. But I already have Sjögren’s Syndrome which was affecting the salivary glands, so my glands don’t hardly produce any saliva anyway. But they swelled up. And so eventually, my consultant said, “We’ll try some radiotherapy.” So they put me down and I think it was supposed to be, as far as I remember, five sessions of radiotherapy. I went for the first session, and that night my glands swelled up even more and became extremely painful, and so I was supposed to go back the next day for the next treatment and they told me not to come to - by the morning they had, the pain had gone away so they told me they’d leave it for a bit. And eventually, I think it was about a week later, I had a second dose and luckily there were no bad effects that time. But the next day the glands were completely flat, so I didn’t need five sessions. It worked in, in two. And I mean the consultant couldn’t believe it when he saw me, how well it had worked.

 

So it’s only with hindsight now I think if I had had the courage to stop after two and a half weeks, I probably would have been perfectly all right. And also I wouldn’t have the lung damage which I’ve got now which, you know, is due to the radiotherapy. So I’ve got bronchiectasis and pulmonary fibrosis. I get very, very breathless, and I feel if I’d stopped at two and a half weeks I probably wouldn’t have been so badly affected.

 

 

Well, they’re a bit cagey about saying that it’s [laughs], it’s related to the treatment. They say it might be and it might not be. But I know it is [laughs].

 

FOOTNOTE' The radiotherapy Celia describes for Sjögren’s Syndrome took place after the trial and was unrelated to it, but it is this experience since which has led her to think that she is very sensitive to radiotherapy. This is why she feels it might have been better for her to be in the trial group having only the two and a half weeks of radiotherapy for the lymphoma.

 

Sjögren’s syndrome is an autoimmune condition, in which the body attacks its own moisture-producing glands, such as the tear and salivary glands. In some cases, other organs of the body are also affected, including the kidneys, liver, pancreas, lungs, blood vessels and brain.

Within eleven months of that operation I found another lump, which again they removed and did a, did some more dissection, took more lymph nodes. And they sent me again to see the consultant, and they decided then that it was faster-growing than they had anticipated. They did CT scans and it was suggested that I went on the interferon trial. That trial was you’re either - we all had four weeks of intravenous interferon, and then some of us went on for another forty-eight weeks to have three, three injections a week, which were self-administered. And we were checked every three weeks to make sure that everything was going all right. And I managed to do a full twelve months, with some side effects - feeling very tired, flu-like symptoms nearly the whole way through, but I did still manage to work. I cut my hours down. I did four days a week instead of five, but I still managed to work.

 

And they thought that had, that was, things were going well. And then I was clear, that was 2005 I had the interferon. Then in 2007, in the September, I found another lump. And they did a CT scan and they decided that the disease had spread. So they needed to do something about it, but there was no, no set medication. I was offered a trial, and I had two treatments of that trial, and I lost all my hair on that trial, had a wig. I was devastated about losing the hair, but I had a wig and most people said it looked quite normal. So that wasn’t too bad.

 

But then found after another CT scan that it wasn’t actually working because there were five lesions, and it had shrunk, started to shrink one but none of the others were shrinking. So they decided that it wasn’t worth carrying on. So I was then told, “Well, that trial’s not working.” And that is the only time that I felt really let down, because the doctor told me didn’t explain that, “Well, that one’s not working but we can try something else.” It wasn’t until I was told, “That one’s not working.” And I sat there and thought, “Where do I go from here?” And I had to ask the question, “Well, is there anything else?” And it wasn’t until I asked that question that, “Well, yes, there might be other trials, but you have to have a break.”

FOOTNOTE' Anthea has been in three trials. Here she is talking about the first two, a 12-month randomised trial of interferon, followed by a non-randomised trial of paclitaxel (Taxol).

I’m actually a doctor and I work in public health, and I was working in [county] and I was in charge, I’d just been put in charge of the diabetes strategy there, and so it made me interested in the fact that nearby they were running a diabetes intervention trial, and it was for people who were well but who might be at high risk of diabetes, so people with a family history. So I decided to just go along because I thought “Well, it would be interesting and I’d be interested in participating, I’m interested in research.” And what happened in that trial is they, screening well members of the public, are looking for people who had high blood sugars but not, not diabetic levels, to see whether certain medications would prevent diabetes actually coming on, so people who were at high risk of developing diabetes. And what really surprised me was I actually turned out to have the high fasting blood sugar, so I - which made me eligible to go into the full trial itself. And I, I hadn’t anticipated that at all when I went into it. I was just sort of seeing what they did and you go along and you have your blood taken. And then they called me back and I had the high fasting blood sugar, which meant I was eligible for the trial. At that point they said “Where there any questions?” and so I started asking the research nurse whether there are other interventions like exercise and diet which could help, and she more or less said no, and she was very vague, wasn’t very sure, but she didn’t think there was otherwise they wouldn’t be doing this trial.

 

So I was rather upset at the lack of information that was forthcoming, having had a high fasting blood sugar, and so I decided to go off and look it up myself, and so I went on and found out that, you know, diet and exercise actually do - you know, there are other things you can do as well as taking medications. And so I was a little concerned that the level of staffing at the trial, that their staff were so poorly informed about this - which was fine, I was still going to go into the trial. And then a routine visit to my GP, you know, just to get a renewed prescription and he had in front of him a piece of paper telling him I had a high fasting blood sugar, and I was really annoyed because I had not been consented for my GP to be informed anything about this, and at that point I decided I would not go into the trial, because I just didn’t think it was ethical that they had breached my confidentiality in this way, so I just withdrew from the trial and didn’t do it.

 

Footnote' The UK Clinical Research Collaboration points out that current ethical guidance is that if you agree to take part in a clinical trial, all your trial records and any information that is collected about you will be kept confidential, in the same way as your medical records. The researchers cannot tell anyone that you are in the trial without asking you first.