Clinical trials are typically conducted in different phases. Each phase is designed to answer certain questions. Knowing the phase of the clinical trial is important because it can give you some idea about how much is known about the treatment being studied. There are advantages and disadvantages of taking part in each of the different phases of a clinical trial.

Clinical trials for mesothelioma cancer passes through this different stages:

1-Phase 0 clinical trials: Does the new drug work? How does it work?

Phase 0 studies are exploratory studies that involves the use of few small doses of a new drug in each patient. They test to find out whether the drug reaches the tumor, how the drug acts in the human body, and how cancer cells respond to the drug. The patients in these studies must have extra biopsies, scans, and blood samples. The biggest difference between phase 0 and the later phases of clinical trials is that there is no chance of a direct benefit to the patient from taking part in a phase 0 trial. Because drug doses are low, the chances of risks is less compared to the other phases of the clinical trial.

Phase 0 studies help researchers find out early which drugs do not do what they are expected to do. If there are problems with the way the drug is absorbed or acts in the body, this should become clear very quickly in a phase 0 trial. This process may help avoid the delay and expense of finding out years later in phase II or even phase III clinical trials that the drug doesn’t act as it was expected to based on lab studies.

The studies are very small, mostly with fewer than 20 people. Although this phase 0 is not a compulsory part of testing a new drug, it is used as part of an effort to speed up and streamline the process of testing new drugs.

2-Phase I clinical trials: How safe is the new treatment?

Although the treatment has been tested in lab and animal studies, the side effects in people can’t always be predicted. For this reason, these studies usually include a small number of people (15 to 50). These studies are usually done in major cancer centers.

The main reasons for doing phase I studies are to find out the highest dose of the new treatment that can be given safely (without serious side effects) and to decide on the best way to give the new treatment. The first few people in the study often get a low dose of the treatment and are watched very closely. If there are only minor side effects, the next few patients may get a higher dose. This process continues until doctors find the dose that is most likely to work while having an acceptable level of side effects.

Safety is the main concern at this point because this is usually the first time the treatment has been used in people. Doctors keep a close eye on how the people in the study are doing. They watch for any common but serious side effects. Special tests, such as blood tests to measure levels of the drug in the body at certain time points, are often a part of these clinical trials. Some studies may require time in a hospital.

These studies are not designed to find out if the new treatment works against cancer. Overall, these trials are the ones with the most potential risk. And only phase 0 has a smaller chance of helping you than phase I. But phase I studies do help some patients. For those with life-threatening illnesses like mesothelioma, weighing the potential risks and benefits carefully is needed.

3-Phase II clinical trials: How effective is the new treatment?

If a new treatment is found to be reasonably safe in phase I clinical trials, the treatment can then be tested in a phase II clinical trial to see if it works the way researchers think it will.

Usually, a group of 25 to 100 patients with mesothelioma cancer gets the new treatment in a phase II study. They are treated using the dose and method found to be most safe and effective in phase I studies. In a typical phase II clinical trial, all the volunteers usually get the same dose, and no placebo is used.

But some phase II studies do randomly assign participants to 1 of 2 treatment groups, much like what is done in phase III trials (see below). These groups may get different doses or get the treatment in different ways to see which provides the best balance of safety and effectiveness. Phase II studies are often done at major cancer centers, but may also be done in community hospitals or even doctors’ offices.

Doctors look for some evidence that the treatment works. The type of benefit or response they look for depends on the goals of the clinical trial. This may mean the tumor shrinks or disappears. Or it might mean there is an extended period of time where the tumor does not get any bigger, or there is a longer time before a cancer comes back. In some studies the benefit may be an improved quality of life. Many studies look to see if people getting the new treatment live longer than they would have been expected to without the treatment.

If a certain percentage of the patients benefit from the treatment, and the side effects aren’t too bad, the treatment is allowed to go on to a phase III clinical trial. Along with watching for responses, the research team keeps looking for any side effects. Larger numbers of patients get the treatment in phase II studies, so there is a better chance that less common side effects may be seen.

4-Phase III clinical trials: Is it better than what’s already available?

Treatments that have been shown to work in phase II studies usually must go through one more stage of testing before they are approved for general use. Phase III clinical trials compare the safety and effectiveness of the new treatment against the current standard treatment.

Phase III clinical trials usually have a large number of patients, at least several hundred. These studies are often done in many places across the country (or even around the world) at the same time. They are more likely to be offered by community-based oncologists.

Because doctors do not yet know which treatment is better, patients are often chosen at random, (called randomized) to get either the standard treatment or the new treatment. When possible, neither the doctor nor the patient knows which of the treatments the patient is getting. This type of study is called a double-blind study.

As with other studies, patients in phase III clinical trials are watched closely for side effects, and treatment is stopped if they are too bad.
Randomization is used in many phase III studies because it helps reduce the risk that one group will be different from the other when they go into the study, which could affect outcome. Blinding reduces the risk that the doctors will be biased in their evaluations of the patients’ outcomes. These controls help make the study results more credible.

5-Phase IV clinical trials: What else is there to know about the drug?

Although a drug might have been approved for general usage, the full effects of the treatment may not be known, and their might still be some questions about the drug that are yet to be answered. For example, a drug may approved by the relevant drug regulatory authority based on the fact that it was shown to reduce the risk of cancer recurrence but does this mean that those who get it are more likely to live longer? Are there rare side effects that haven’t been seen yet, or side effects that only show up after the drug is used for a long time? These types of questions may take many years to answer fully, and may not be critical for getting a medicine to market. They are often addressed in what are known as phase IV clinical trials.

Phase IV studies look at drugs that have already been approved by the relevant drug regulatory bodies. They are already available for doctors to give to patients, but these studies are still needed to answer important questions.

When thinking about taking part in a phase IV trial, you should know that the drug has already been approved for use. The care you would get in these types of studies often is very much like what you could expect if you were to get the treatment outside of a clinical trial. You should be reassured that in taking part you would be getting a form of treatment that has already passed through different phases of testing and that you would be doing a service to future patients.

Bello kamorudeen.For more information on Mesothelioma treatment go to http://www.mesotheliomacorner.blogspot.comArticle Source:http://www.articlesbase.com/cancer-articles/what-are-the-different-stages-of-a-mesothelioma-clinical-trial-1339878.html

Mesothelioma is a cancer associated with asbestos exposure. Fortunately, it is very rare compared to other forms of cancer in the general population. Unfortunately, it has a very high mortality rate. In this article, we take a look at some common questions and answers regarding it.

Q: Why have some a difficult name?

As if being diagnosed with cancer isn’t bad enough, most people are more than a little frustrated that they can’t even pronounce the name of it. “Me..so..thee..lee..ohma” is not a name just conjured from the air. Instead, it gets its name from the part of the body where the cancer tends to manifest – the mesothelium. The mesothelium is a lining found in the chest cavity and abdomen. It surrounds most organs including the heart and lungs. The lining consists of two layers with a lubricant between them. When the heart beats or the lungs take in air, the mesothelium lets them move without damaging one another.

Q: Am I Going To Die?

Well, we all are going to die at some point. I could get hit by a bus tomorrow and so could you. That being said, the first question is whether you have a benign or malignant form of the cancer. The benign version is, of course, not going to lead to fatality. Ah, but what about the malignant form.

A diagnosis of malignant Mesothelioma is often fatal, but not always. Approximately 9 percent of patients survive five years after being diagnosed.  The key is to make it through the first 2 years. Most patients die during this period, but those that live longer usually survive.

Q:  What Course of Treatment Is There?

The treatment course for Mesothelioma depends entirely on your specific condition. There are different stages of the cancer and each has its own typical treatments. In general, you can expect surgery to remove areas of cancerous growth including potentially a lung. You can also expect this to be combined with very aggressive chemotherapy and radiation therapy. Mesothelioma is also one area where doctors are universally very aggressive. You will want to confer with a Mesothelioma specialist, and can expect them to recommend you participate in clinical trials of potential treatments that have not been approved by the FDA yet.

A Mesothelioma diagnosis was a death sentence 20 years ago. This is no longer the case. If you, a friend or loved one is diagnosed with it, be positive and aggressive in seeking treatment.

Thomas Ajava is with NiagaraMesotheliomaLawyer.com – your online resource for finding a Niagara Mesothelioma lawyer to handle your case and answer your questions.

Article Source:http://www.articlesbase.com/cancer-articles/mesothelioma-common-questions-and-answers-1335534.html

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It goes without saying that “chances” and percentages should be taken for what they are – an estimate. If something happens 9 out of 10 times, there is still a decent chance that you might be that 1 out of ten times. The survival rate of any cancer should be taken only as a guideline, not anything more than that. Patients beat cancer all the time and there is no reason that you can’t either.

The survival rate with Mesothelioma is done on a five year projection. This simply means that the number of patients surviving the cancer are compared through each of the five years after diagnosis. For instance, 39 percent of patients diagnosed with Mesothelioma survive for more than a year. Unfortunately, the numbers go down from there with 20 percent surviving 2 years, 11 surviving three years, 10 percent surviving four years and 9 percent surviving 5 years. All and all, these are not great numbers.

So, let’s ask the obvious question. Are you doomed if diagnosed with Mesothelioma? No! Mesothelioma has been studied significantly and a wide range of treatments have been tried over the years. As a result, there is no a fairly clear course of treatment – aggressive. Doctors know that they need to go for broke and Mesothelioma survival rates are actually going up compared to years ago. The key is to be positive and be ready to undergo aggressive surgery, radio therapy and chemotherapy.

It should also be noted that there are a host of new treatments going through FDA clinical trials. These treatments attack Mesothelioma in many different ways. As a person diagnosed with the disease, you can participate in the trials. You can contact the National Cancer Institute to get a list of trials being conducted.

If you have to get cancer, Mesothelioma is not really the one you want. That being said, it is no longer an automatic death sentence. Be positive and demand aggressive treatment. Get a referral to a Mesothelioma specialist to ensure you are getting the latest treatments possible. People survive and you can as well.

Thomas Ajava writes for MesotheliomaAttorneyAssistance.com – locate Mesothelioma attorney assistance for your case.

Article Source:http://www.articlesbase.com/cancer-articles/mesothelioma-what-are-your-chances-after-a-diagnosis-1330825.html

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Though mesothelioma is not a cancer that is related to poor nutrition, improving nutritional intake can help mesothelioma cancer patients fight the progressive disease.

Consumption of a healthy diet is crucial to the healing process. Vitamins, minerals, carbohydrates, lipids (fats) and proteins all play major roles in a healthy human body. These groups of foods are known to prevent the accumulation of certain chemicals called free radicals in the body which are believed to be responsible for the development of diseases like cancer in the body.

The right balance of nutrients help the body to effectively fight cancer. In addition, malnutrition causes the body to be susceptible to infection. Many cancer patients do not pass away from the cancer itself, but rather a medical condition stemming from the body’s weakened condition.

If you have been diagnosed with mesothelioma cancer, it is important to discuss a nutritional plan with your doctor. This can be as important as radiation, chemotherapy or other forms of cancer treatment. Your chances of a good outcome are greatly improved with the right nutritional plan.

In addition to improving chances of survival, proper dietary care can help relieve some of the uncomfortable symptoms of cancer. This helps to improve the quality of life even if the cancer is in very advanced stage and death is imminent.

One of the most common side effects of cancer and cancer treatment is nausea. There are a number of dietary changes you can make to help this problem. Dry grain products like crackers and toast can help calm an upset stomach. Bland foods will also help with nausea, as well as acid reflux problems.

Decreased immunity as a result of reduced white blood cell count is also another common complication of cancer, this increases your chances of contacting an infections. To cope effectively with this state of vulnerability to infections you should make some changes in the foods you eat. It is most important to avoid bacteria, which is common in foods that are damaged or not prepared well. Avoid buffets when eating out, wash your hands before preparing meals, avoid raw meats and fish (like sushi) avoid eating uncooked meals like salad and cold slough, and throw away any foods that are bruised or damaged.

Cancer is a complex medical condition, with many factors playing various roles in development and treatment. However, most patients will undoubtedly benefit from a better diet in a number of ways. In addition to eating a balanced diet, use the following tips to help strengthen the body’s ability to function well and fight disease:

• Avoid alcohol in excess amounts.

• Monitor weight carefully, not only being sure to stay trim, but also being sure to avoid becoming too thin.

• Learn about safe food preparation techniques.

• Cut the “bad” fats from your diet, opting instead for “good” fats, such as olive oil.

• Choose fruits and vegetables daily (these food groups should represent the bulk of your diet, approximately 50 percent).

• Avoid processed foods, like prepackaged meals.

• Make healthy choices when eating out, opting for low-carb or vegetable-based meals when possible.

• Monitor the types of fish you eat, choosing species low in mercury.

• Buy products that are organic.

• Do not eat fast food.

• Cut tobacco products out of your life.

• Take a multi-vitamin every day.

• Include adequate amounts of fiber in your diet.

Be sure to talk to your doctor to learn about more ways to improve your chances of survival, modifying your diet lifestyle will strengthen your body to fight this mesothelioma cancer more readily.

Bello kamorudeen.For more information on mesothelioma treatment go to http://www.mesotheliomacorner.blogspot.comArticle Source:http://www.articlesbase.com/cancer-articles/important-nutritional-tips-for-mesothelioma-patients-1317335.html

Asbestos, Asbestosis, and Mesothelioma Toolkit – Comprehensive Medical Encyclopedia with Treatment Options, Clinical Data, and Practical Information (Two CD-ROM Set)

This up-to-date and comprehensive set of two CD-ROM discs provides a superb collection of official Federal government documents on the subject of asbestos, asbestosis, and mesothelioma. Asbestos is the name of a group of minerals with long, thin fibers. It was once used widely as insulation. It also occurs in the environment. Asbestos fibers are so small you can’t see them. Disturbing asbestos can cause fibers to float in the air. When this happens, they are easy to inhale. You breathe out most …more

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