Chemotherapy Clinical Trials
If you have been diagnosed with cancer, chances are you have heard the word chemotherapy since receiving your diagnosis. You may also be unnerved by the word, which you may equate in your mind with weight loss, fatigue, and an overall sense of malaise. Historically, many chemotherapy drugs have caused such side effects, however newer and less-toxic drugs have been discovered in recent years.
Many are also easier to administer, with dosing often accomplished by simply taking a few pills, rather than being hooked up to an IV for an extended period of time. New chemotherapy drugs are constantly being investigated in clinical trials, which can be welcome information for a cancer patient whose tumor has failed to respond to standard chemotherapy.
What Will Chemotherapy Clinical Trials Be Like?
Clinical trials in chemotherapy are done when researchers think that a new chemotherapy drug (or a new combination of drugs) may help to cure or control the growth of a particular cancer. After the new chemotherapy drug has been tested in the laboratory as well as in animals, they are then tested in human clinical trials in order to determine their safety and effectiveness.
Clinical trials in chemotherapy are conducted in phases, and the phase of the study will ultimately determine the specific procedures that you will undergo. Below is a brief summary of what can be expected:
- Blood tests
- Urine tests
- Physical exams and/or phone interaction with research personnel.
- Blood and/or urine tests may be performed to monitor how your body metabolizes the medication.
- Imaging procedures such as computed tomography (CT scan, or “CAT scan”) or magnetic resonance imaging (MRI) scans. These imaging procedures are non-invasive and provide detailed pictures of areas inside your body.
- Quality of life assessments to evaluate how your cancer is impacting your ability to perform activities of daily living.
- Pain assessments
- Performance status measures
Typical Chemotherapy Clinical Trial Protocol:
The design of a specific chemotherapy protocol depends on the drug(s) being investigated, the cancer being treated, and a number of other study-specific factors. On a broad level, the specific phase of the study will dictate the nature of the clinical trial and how it is conducted. A brief summary of typical clinical trial designs for chemotherapy related studies is below:
Phase I: These studies are small and typically enroll no more than a few dozen individuals. They are used to test an experimental chemotherapy drug for the first time in order to evaluate its safety, determine the highest dose that can be administered with the fewest side effects, and identify what side effects are most common.
Phase II: These studies involve greater numbers of patients than phase I studies to further investigate the chemotherapy drug’s effectiveness and safety. Its impact on the development/progression of the cancer may also be examined.
Phase III: These studies continue to investigate the chemotherapy drug in large numbers of patients (over 1,000+) to confirm that it is effective and safe, continue to monitor and confirm possible side effects, compare it to standard chemotherapy drugs, and collect additional information (such as quality of life information, cancer-specific information, etc.)
Phase IV: These studies, often called “post-marketing studies” are conducted once a drug has been approved for sale and are commercially available. They are used to provide additional information regarding the risks and benefits of the chemotherapy drug, as well as the conditions for its optimal use.
A brief word about randomized trials and placebos:
Many clinical trials involve the comparison of an investigational treatment to a “standard” treatment. Some studies determine which therapy a patient receives through a process known as randomization, in which patients are randomly assigned to receive either the investigational treatment or the standard treatment.
On occasion, a trial will investigate the use of a standard treatment plus a new drug compared to standard treatment plus a placebo. Placebos are inactive or “sham” treatments that are identical in appearance to the active treatment but have no therapeutic value.
Placebos are necessary to help determine if adverse effects that occur during the clinical trial are the result of the investigational treatment or due to some other factor. They also allow researchers to measure the effects of the active treatment and observe what would have happened without it.
In rare instances where no standard therapy exists, or when a new drug is being evaluated for the first time in a specific cancer, the investigational treatment might be compared to a placebo alone. In these types of trials, those patients who are randomized to the placebo group do not receive an active treatment.
This is rarely done in cancer clinical trials; however it may occasionally be necessary from a scientific standpoint. Placebo-only trials will only be done when ethically appropriate and when patients have been adequately informed that they may end up receiving the placebo rather than the active treatment.
It is very important to note, however, that no one should ever participate in such a placebo trial when there is a widely available and highly effective standard treatment already in existence for their particular type of cancer and clinical situation.
Trial Eligibility and Medical Information Needed:
The type of clinical trial you may be eligible for often depends on many factors, including your disease stage, treatment history, and a variety of clinical findings. Therefore, it is important to know many details pertaining to your specific diagnosis when searching for clinical trials. Examples of the details you will want to have on hand include:
- The name, location, size, stage, and cell type of your cancer, as well as the locations of any metastases you have. Also know these details for any prior cancer you have had.
- Know your performance status, which estimates how well you perform normal activities of daily living. Examples: Karnofsky Performance Scale (KPS) and the ECOG scale.
- Know your treatment history, including chemotherapy, radiation therapy, immunotherapy, and/or surgery.
- Know your blood cell counts, liver function test results, and kidney function test results.
Suggested Search Methods:
Although there are exceptions, most chemotherapy clinical trials (especially those in early phases of research) investigate the drug in patients with a specific type of cancer. Therefore, the best approach for identifying relevant chemotherapy-oriented clinical trials is to search in relation to the type of cancer you have.
For example, if you have been diagnosed with lung cancer, the following search terms might be the most useful: “lung cancer chemotherapy,” “lung cancer treatment,” and “chemotherapy lung.” If you have breast cancer, substituting the word “breast” for the word “lung” will likely provide the most relevant results, and so on.
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