Category Archives: Trial

Dec31

Appointments ~ all change!

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Tuesday 31st December

The trials nurse from Exeter rang three times today ~ she joked she felt like my stalker! What she was doing, was trying to arrange all my appointments into as few days as possible. And I think she’s succeeded.

This Thursday I have a CT scan, an ophthalmic review and an ECG, all at Exeter hospital.

The following Monday I go to cardiology for an Echo cardiogram, then oncology for bloods and obs, and finally to surgical out-patients to visit with my plastic surgeon for an eight week review following surgery.

A week Tuesday I have an appointment at the Pigmented Lesion clinic for a full dermatological check-up. This will be followed by a visit to the trials nurse for more blood and obs, an appointment with my oncologist, where ‘randomisation’ takes place, and I’m issued with my first course of medication. Combi-Ad. Things are beginning to get serious.

I also have appointments closer to home as well, with the lymphoedema nurse, the occupational health officer, and at the local surgery for a pap smear.

I am entering new territory, feeling rather apprehensive, a little scared, but oh so hopeful and positive for what lies ahead.

As 2013 comes to a close, I will awake tomorrow assured that all my consultants, specialists, doctors and nurses all want the very best for me.

And I’m with them on that one! Bring on 2014, I’m ready to fight for my health!

Dec18

Three nurses’ telephone calls

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Wednesday 18th December

Yesterday we left Exeter and drove to Plymouth where we spent about four hours Christmas shopping. I took it slow, stopping for coffee breaks and lunch, but by the end of the day, my foot, ankle, calf, knee and thigh were incredibly swollen. Up until now, my only exercise has been bursts of about twenty minutes, going from the house, to the car, to the local supermarket, and then sitting in a coffee shop.

So on Wednesday I didn’t get out of bed. The swelling of my left limb was quite scary, and I didn’t want to risk any further problems. I lay there, with my leg elevated, and dozed for most of the day.

The first phone call I received was from one of the Macmillan nurses asking how I was doing, and whether I had made a decision on the Truro trial for Brim8 (vemurafenib). I apologetically declined, stating the very frequent monitoring, increased side effects, and the fact that all I had read made the Exeter trial, Combi-Ad, the more preferable. She was very understanding, and thought that would be my decision anyway. She also made an appointment for me to see the other Macmillan nurse after Christmas.

The second phone call I took was from the trials nurse in Truro; she wanted to know my decision. I felt a little bad declining their offer, but she too was most understanding.

Finally, I was called by the lymphoedema nurse at the local hospital in Hayle. We organised an appointment for later in January, where she would show me lymphatic drainage massage to control the swelling of my leg, and when she would take a lot of measurements of my leg, ready to have garments fitted. ‘Garments’???  Oh, those wonderful support stockings that guard against lymphoedema.

Well, anything that helps me return to some semblance of normality, I suppose I will have to accept. Trials, tests, monitoring, travelling, even support hose ~ if I value my life, I will do as the experts direct me.

Dec16

I sign up!

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Monday 16th December

Just over two hours after leaving home, we are being seen by a lovely trials nurse at the hospital in Exeter.

Today is the day I sign my body over to GlaxoSmithKline.

We are taken to a very comfortable consulting room and the nurse goes through the different tests I will be put through before I get the go ahead to take part in this trial. A complete physical examination. These include CT scans, MRI scans, electrocardiogram, echocardiogram, vital signs, blood tests, eye exam and a pregnancy test!
I need to be ‘randomised’ before February 4th.

These are the details from the trial documentation:

“A Study of the BRAF Inhibitor Dabrafenib in Combination With the MEK Inhibitor Trametinib in the Adjuvant Treatment of High-risk BRAF V600 Mutation-positive Melanoma After Surgical Resection.

This is a two-arm, randomized, double-blind Phase III study of dabrafenib in combination with trametinib versus two placebos in the adjuvant treatment of melanoma after surgical resection. Patients with completely resected, histologically confirmed, BRAF V600E/K mutation-positive, high-risk [Stage IIIa (lymph node metastasis >1 mm), IIIb or IIIc] cutaneous melanoma will be screened for eligibility. Subjects will be randomized to receive either dabrafenib (150 milligram (mg) twice daily [BID]) and trametinib (2 mg once daily [QD]) combination therapy or two placebos for 12 months.

Primary aim: Relapse-free survival (RFS)
Secondary aim: Overall survival (OS) of dabrafenib and trametinib as a combination therapy versus placebo; approximately 5 years;
Distant metastasis-free survival (DMFS) of dabrafenib and trametinib as a combination therapy versus placebo; approximately 32 months;
Freedom from relapse (FFR) of dabrafenib and trametinib as a combination therapy versus placebo; approximately 32 months;
Safety of dabrafenib and trametinib as a combination therapy in the overall study population; approximately 5 years.”

So, this is what I have signed up for.
It really is frightening and scary territory for me.
Having read a lot about this trial, and spoken (via the Internet), to people already on the trial, there seems to be a lot of hope and positivity for it.
Without help and advice from these people I would be walking a lonely minefield of ignorance

From the oncology waiting room, I then move along to the one at surgical outpatients. We have about a forty five minute wait, but are then called to one of the consulting rooms. It is almost five weeks since my plastic surgeon operated on me. The scar is incredibly neat, and healing well. However, I still have the drain bag attached, and my lumpy, red cellulitis is a pain in the neck! Apparently it’s all normal-ish . . . . the drain fluid is a straw colour, a good sign, but the hard, half-grapefruit-sized lump is an unwanted side effect. As I have no lymph nodes on the left hand side, lymphatic fluid has nowhere to drain, so it collects in pockets, and sometimes becomes infected, resulting in cellulitis. Oh joy! I must keep the bag stuck to my leg, and am given a new, two-week dose of broad-spectrum antibiotics.

My surgeon is great, and really easy to talk to about any problems or fears I may have. I am told the swelling will go down eventually, and cosmetically, I will have a very discreet, tidy scar. I am due to see him again in the New Year for a two month review.

Dec12

Another day. Another trial.

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Thursday 12th December

Another long drive up to Exeter today, this time, to visit with a second oncologist to discuss a second drug trial in two days! Unlike the information from yesterday, this one combines two drugs: dabrafenib and trametinib, but alike, in that it is double-blind ~ drugs vs placebo, no-one knows if you are taking the drugs or not.

My appointment was for 3:45pm, but because of the horrendous parking situation, we rolled up with an hour to spare. Both of us are becoming quite good at sitting in waiting rooms! We finally went in about 4:10pm. Firstly we spoke to the trials nurse for about five minutes, then the Macmillan nurse for about ten minutes. She wanted to check my wound, drain and the extent of the infection and the cellulitis ~ it is normal apparently, following a groin dissection, but she did sympathise with me, and the pain and discomfort I was having.

Then they both left . . . and we waited and waited and waited . . . . . for almost an hour, my husband and I were in that room on our own!!!! Staring at the walls, opening the door, looking out of the window. The oncologist finally showed up about 5:20pm, apologised that a colleague had had a bicycle accident, resulting in broken bones, and that had messed up his schedule.

Hmmmm.

Anyway, we spoke for about 50 minutes about the trial ~ the drugs, possible side-effects, scans, tests, travelling to Exeter, emergencies, signing of the consent form, and interactions with my morning pill-popping of various vitamins, minerals and supplements

He said he would get the trial nurse to phone me to talk about all the pills I take, to make sure none are on the prohibited list ~ maybe turmeric, cinnamon and resveratrol, and then we’re good to go, to start the initial battery of tests, probably in the new year.

We did come away feeling quite positive, despite the loooooooong wait!!!!
We eventually exited the building at ten past six, arriving home about 8:30pm, in the end.

I believe my mind is made up, and I will go with the newer Combi-Ad trial, with slightly less side effects, and not as much scrutiny via relentless full body, invasive tests. Even if I get the placebo arm of the trial, I will be very well looked after, plus I won’t suffer the side effects ~ hmmm, sounds like a good plan to me!