Feb 14, 2015

Nobody in a clinical trial wants to be given a placebo, whatever that is…

“Placebo” is often used in a negative way. But that’s not necessarily true. Placebos are sometimes used in clinical trials. A placebo is a biologically neutral substance packaged to look like the real drug. Although often referred to as a sugar pill, many placebos are not even pills. They are simply inactive compounds packaged to look, feel, and appear like an active drug. They may be an injection, IV infusion, capsule, a cream, an inhaler, a skin patch, or take any other form that is used by an active drug.

Placebos are used when the purpose of the research is to compare different approaches to treatment. The placebo helps ensure that the study is double blinded which means neither the doctor nor the patient knows which treatment is being administered. Many cancer patients are understandably concerned that they might get a sugar pill instead of a real treatment. This is often the first question the physician researcher hears when a clinical trial is brought up as an option, “Will I get the real thing or just a sugar pill?”
When placebos are used
The fundamental principle that defines when placebos are appropriate is rather simple: if you have cancer, and a treatment that works is available, a placebo cannot be used instead. Period‑‑end of story. Research is not and cannot be about withholding effective treatments from patients with cancer. A placebo can be used in two research situations:
1          There is no effective treatment and the standard treatment would be observation or perhaps supportive treatment (treatments designed to lessen symptoms but not treat the disease).
2          There is an effective treatment and this treatment is being given to all patients in the study. The placebo is being added to the known effective treatment to allow a comparison between the standard treatment and a combination of the standard treatment plus a new drug of unknown effectiveness.

The Placebo Effect (this is kind of weird)
The most mysterious benefit of having a placebo in a study is that placebos actually do work! Now you may think we are completely losing our minds (always a possibility), but it is true! The degree to which placebos work varies considerably depending on what disease is being studied, but it stands to reason that if we are going to devise a fancy, expensive, patented new drug with an unpronounceable name, it should produce results better than a mere sugar pill. According to the American Cancer Society, placebos have an effect on about one in three patients. Often the result is a reported improvement in a symptom or in quality of life. Sometimes it could actually be a new side effect. The mechanisms through which placebos work may represent, to some extent, the importance of the mind-body connection.

A placebo can reinforce patients’ belief that they will get better and so they actually do. In general, placebo effects are seen as symptoms or things people feel. The actual shrinkage of cancer tumors would be extraordinary. Nevertheless, many studies of new cancer drugs look beyond tumor shrinkage and length of life following a cancer diagnosis. They examine quality of life, symptoms of cancer, and side effects of the drug. Placebos allow us to see the true picture of what a new drug can offer beyond what you could get from a sugar pill.
There’s more to learn about the placebo. Watch for the next chapter!


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To put a smile on your face see Larry's latest cartoon.
To learn more about clinical trials, take a look at our book.

(c) 2012 Tom Beer and Larry Axmaker

Jan 29, 2015

The Right Clinical Trial for You—Part 4



Attitudes, Emotions, and Reality in Choosing a Clinical Trial
Having cancer is a medical reality. Thinking about cancer can have a significant emotional impact on you, your family, and your friends. The process of coming to terms with your diagnosis, maintaining your life as normally as possible, and then looking at clinical trials can be emotionally difficult.

First of all, not many people actually believe they will ever be diagnosed with cancer. We all know other people who have cancer, but in our mind it just couldn’t happen to us. That’s just human nature. But, unfortunately, it can happen to us. The facts say about half of us will get diagnosed with cancer in our lifetime—some of us more than once.

Survivor!
Most of us probably fit into the category cancer survivor, and we have gone through a lot of emotional ups and downs already. Being diagnosed with cancer can be a traumatic experience. You already know all about that. Calling yourself a survivor has a certain determined, optimistic sound to it. That’s a good place to start.

Some people feel so discouraged after a cancer diagnosis they can’t really focus on anything else‑‑at least for a while. It’s normal to initially feel depressed and anxious, “I’ve got incurable cancer and I’m going to die!” That’s a horrible feeling regardless of whether it’s true or not.

Whatever you feel is very real to you. Your feelings may not be logical, rational, or reflect reality (that’s why they’re called feelings and not facts) but they have a major impact on what you think, how you act, and what you decide to do or not to do. That includes choosing to join (or not to join) a clinical trial.

According to the National Cancer Institute, about half of those with incurable cancer experience some serious emotional distress and anxiety. People with cancer can experience PTSD (post-traumatic stress disorder), just the same as accident victims or soldiers in combat. Cancer survivors commonly experience fatigue which can make it more difficult to make decisions and take actions that might benefit you. As if the cancer itself wasn’t bad enough!

“Just leave me alone!”
Whatever you’re feeling is probably shared by many others with cancer. It’s common to want to be alone and avoid the sympathy and concern of others, even your family and closest friends. Isolation might seem to help, but more likely being alone will increase your stress. You can feel sad, happy, angry, and discouraged‑‑all at the same time. This emotional roller coaster can keep you from getting the help and support you need and from making important decisions. Try not to let that happen; tell yourself that you’re in control and then take charge!

The American Cancer Society (ACS) suggests some things you can do to help manage worry and stress:
1 Just talking about your feelings can help relieve worry and stress. 
2 Trying to relax with deep breathing and other techniques can be helpful. Doing it regularly works best. 
3 Allowing yourself to feel sad and frustrated without feeling guilty about it is perfectly OK and you have every right to do so. 
4 Choosing the right person to talk with can be important. That person could be a good friend, family member, or a spiritual counselor. 
5 Spiritual help is useful for many people. 
6 If the worry persists or gets worse, get help from a mental health professional.

And you want me to join a clinical trial on top of all that?
In the middle of the emotional roller-coaster and facing a relapse or progression of your cancer, you’re now considering experimental medicine‑‑a clinical trial. It can be hard to make calm, logical decisions when you are in the midst of a personal crisis. To top it all off, the information you’ve been hearing from others may not be completely accurate or very helpful.

Human Nature
Good old human nature can trip you up on the way to considering a clinical trial. There is a strong tendency for some (probably many) people, when under stress or in crisis (being diagnosed with cancer, for example), to resist any change or new treatment that takes them out of their own comfort zone. Just a few thoughts that might come up:
“I don’t have the time” 
“It’s just a waste of my time.” 
“What’s the use?” 
“I know it won’t work.” 
“What do those doctors and drug companies know?” 
“They just want to use me to make lots of money for them!” 
“There’s no way I’m going to be somebody’s guinea pig!”
·         “And what about those stories of clinical trials gone wrong?”
Your Choice
Most clinical trial participants report a good experience—but not necessarily a cure. Spending time with the medical professionals and sometimes with other participants can be good for your mind and body. And you can always choose to opt out.


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To put a smile on your face see Larry's latest cartoon.
To learn more about clinical trials, take a look at our book.

(c) 2012 Tom Beer and Larry Axmaker

Jan 3, 2015

The Right Clinical Trial for You—Part 3




 What Should You Expect from the Clinical Trial?
You should be comfortable and know you will be treated well when you participate in a trial. You certainly hope the trial will be a success and your cancer will be managed (or even cured, but that is unlikely), but you know that there are no guarantees. What you can expect is that your health and cancer status will be monitored closely, that side effects will be managed expertly, and that study doctors and staff will be responsive to your questions and needs. If a drug is not currently approved for use, the drug will be provided free of charge. Some of the tests you will undergo, those done specifically for the research process (e.g., extra biopsies of your cancer or blood samples to measure drug levels), are also provided to you free of charge in most cases. In most clinical trials the routine parts of your care (that would be done if you were getting standard treatment) are not provided free of charge, but are billed to your insurance provider.

What can I expect from my doctor and investigative team?
You can, and should, expect close attention by a team that is often larger than what you would encounter during routine care.
You can certainly expect exceptional care from the whole team. You will almost certainly get more medical attention than if you were on standard care. You should get regular reports about your progress. If you don’t‑‑ask! You’re getting treatment for your cancer and you’re also helping the investigators. You’re a partner in the trial. Be sure to ask, early on, who is the right person for you to contact for specific concerns. Who should you call if you have a question about a scheduling matter, and who do you call if you are not feeling well, have a new side effect, or if you have a medical question? Having that information clarified from the start and having all the right contact information for your research team can go a long way in making the process run smoothly and comfortably for you. You will almost certainly get more medical attention than if you were in standard care. You should get regular reports about your progress. If you don’t—ASK! You’re getting treatment AND you are helping the investigators.

Am I free to quit if I want to?
YES! You agreed to participate, but you always have the right to quit, whether due to side effects or if you’re not comfortable with the trial or for any reason you choose. Talk to your doctor and your trial team before you decide. They may be able to resolve your concerns and answer your questions so you will be able to stay in the program.

What if I have side effects? How will I know if I should be concerned?
A new physical or emotional sensation that is out of the ordinary for you could be an adverse effect. Tell the nurse and doctor about it right away. It is better if you tell them sooner rather than later. There may be ways to manage your side effects. It may also turn out to be unrelated to the trial and could be treated separately while you continue in the trial.
All of this is important because an adverse effect from an experimental drug is different from ordinary side effects, mostly in that less is known about it. It could start out mild and get worse over time if not attended to; sometimes this can happen very quickly. It should be brought to the attention of the research team promptly so they can be evaluated.

Bottom Line
1      Clinical trials are tightly regulated and closely supervised by the study team, institutional committees, independent boards, pharmaceutical companies, and the government. The scrutiny is far more extensive than that of routine cancer care.
2      Most of your cancer care while you’re participating in a study will be billed to and covered by your health insurance. Items that are purely for research, and not done to take care of you, are generally provided free of charge.
3      It is important to establish and maintain clear communication with your entire study team:
A     Find out which members of the team are the right contacts for different types of questions and concerns.
B     Let your study team know about adverse effects (side effects) or concerns promptly.
C     Don’t try to solve problems that arise on your own or wait until your next appointment‑‑contact your team whenever you need to.
4      You are always free to stop being a part of the study. If you are thinking about stopping, be up front with your doctor and research team. You may learn that they can solve the problems or address your concerns without stopping the study treatment.
5      Seek the support of your oncologist, your primary care doctor, your spouse, and those around you while you are making decisions about whether to sign up for a study and while you are participating in the trial.

 

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To put a smile on your face see Larry's latest cartoon.
To learn more about clinical trials, take a look at our book.

(c) 2012 Tom Beer and Larry Axmaker