The C Word – Day 31 Clinical Trials – What are they?

I decided to look at some other blogs today to get some ideas for mine.  I hit a gold mine in one about a young woman, young mother, who has Stage IV breast cancer.  When I clicked on her most recent link she spoke about what the various phases of clinical trials are.  Since what we are about to embark on is, indeed, a clinical trial, I found this quite informative.

I followed through by visiting the National Institute on Health website and this is what I found for definitions:

Question: What are clinical trial phases?

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Answer:

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

·         Phase I: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

·         Phase II: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.

·         Phase III: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

·         Phase IV: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

We will be participating in a Stage III clinical trial.  It has a very, very long name: Clinical Trial of Intraperitoneal Hyperthermic Chemotherapy Utilizing Cisplatin, Doxorubicin and Mitomycin C in Peritoneal Surface Cancers.  It has been going on since August 2006. I don’t know if that is a long time for a clinical trial or not.

According to our oncologist, the research head-honcho at Stanford is not prone to believe that this HIPEC procedure (which is included in this trial) is effective.  However, it is the only game in town.  And this particular game is being played right here near our home so we do not need to travel for it. 

The good news about being included in a clinical trial is that in some states (and California is one of them), the insurance companies cannot deny payment for them.  The bad news, of course, is that we have to be part of the trial because we have cancer.  The good and the bad. 

Good:  We have a wonderful team forming and unfolding right before our very eyes, we are close to home for treatment, we will have a very good hospital involved and we expect the care there to be very good, we are in close proximity to our supportive families and friends, data collected will hopefully lead to a Stage IV clinical trial where there is even more reason for people who have this type of treatment to have more hope for their futures.

Bad:  Two words – cancer and surgery; side effect is pain, possible nausea and whatever else goes along with surgeries, chemo and pain management. 

While neither of us would choose to take this journey (if we had a choice), it is of some comfort to us that we may be helping those in the future.  And, though it is the only game in town, we are anticipating a future of many more years to enjoy life, friends, and most importantly, family.  May God grant us this wish.