Sunday, October 3, 2010

Mesothelioma Clinical Trials

Clinical trials, phases I through III, are experimental treatments that have not yet been proven to be effective enough to be accepted as standard treatment. In fact, they are done for the purpose of determining whether they are or are not effective, and of determining to what degree they are effective. Results from clinical trials are compared with other forms of treatment to determine the most effective treatments under varying conditions. Clinical trials types include:

• Prevention trials

• Screening trials

• Diagnostic trials

• Treatment trials

• Quality-of-life, or Supportive care trials

• Genetics studies

What Kinds of Clinical Trials are Available for Mesothelioma Patients?

Clinical trials for treatment of mesothelioma might be designed to find a new treatment, or to improve a standard one. They test new drugs, radiation therapy, vaccines, new methods of surgery, or new treatment combinations.

Quality-of-life, also called supportive care trials work to improve cancer patients’ and survivors’ quality of life, comfort, or reduce the side effects of treatment or the cancer, itself.

How to Enroll in a Clinical Trial.

If your physician is unable to offer you a treatment or surgical option that he believes will cure, or improve, your condition, you may be eligible to enroll in a clinical trial. Your physician will be able to tell you which clinical trials are appropriate for you, and how to enroll.

Who Pays for Clinical Trials?

Clinical trials are not free. As with any medical treatment, you are responsible to pay for payment. If you have health insurance, you will need to find out whether or not they cover the particular clinical trial you intend to undergo. If your policy states that it considers clinical trials to be experimental or investigative, it may not cover any or your expenses for this treatment.

Increasingly, states are passing laws that require coverage for at least the routine care you would get during a clinical trial. These include doctor visits, hospital stays, lab work and x-rays and other costs common to any covered treatment that you might receive. In most cases the group sponsoring the trial will cover some of the costs of the clinical trials. These would include the costs that are related to tests that are done solely for research purposes.

The National Cancer Institute (NCI) is one of those research groups. NCI is working with major health insurance companies and managed care groups, and Medicare covers patient care clinical trial costs. NCI offers links to articles about clinical trials that may answer many of your questions. Other links to valuable information are at NCI Publications.

What Happens During a Clinical Trial?

There are four phases of treatment clinical trials:

Phase I: First step in testing a new treatment in humans

• Evaluates effective dose, route of delivery, and frequency of treatment

• Evaluates harmful side effects

• Involves only a small number of human subjects

Phase II:

• Studies safety and effectiveness of this treatment

• Evaluates effect on human body

• Limits to a specific type of cancer

• Involves fewer than 100 patients

Phase III: Compares this treatment to the current standard treatment

• Patients are randomly assigned to either the standard treatment or the one under study

• Treatments at phase III have shown promise based upon results from phases I and II

• Involves large numbers of people from many different places in the country

Phase IV:

• Evaluate the long-term safety and outcomes of this treatment

• Usually done after treatment is approved as a standard treatment

• Involves hundreds to thousands of people to ensure consistency in results

A 2002 study at phase III showed that a new chemotherapy drug regimen was effective in extending the lives of mesothelioma patients while reducing pain and discomfort.

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