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Archive for the Clinical Trials category
News from the global front
Cancer to be world’s top killer by 2010, WHO says
The latest report from the World Health Organization brings bad tidings. Global death rate due to cancer is on the rise. This year, the number of cancer cases is expected to reach 12 million and 7 million of these will result in death. By 2010, it will be the world’s leading cause of death. By 2030, the number of cases may be almost triple.
A disappointing end to an otherwise promising clinical trial. It was known as the SELECT (Selenium and Vitamin E Cancer Prevention Trial) and it evaluated whether supplementation with selenium and Vitamin E can prevent prostate cancer. The large-scale long-term study of the National Cancer Institute (NCI) included more than 35,000 male participants in the US, Puerto Rico and Canada. They were randomly assigned to one of 3 groups: group 1 took vitamin E only, group 2 took selenium only, group 3 took both, and group 4 took placebos only.
After, on the average, 5 years of follow up, the NCI decided to cut short the study because of “concerning” findings, namely: More →
It is good news for oncology, bad news for other therapeutic areas - cancer is currently the most studied disease. This is based on the number of studies registered at ClinicalTrials.gov during the last two years, according to heartwire.
The review entitled “Trends in disease focus of drug development” and published in the August issue of Nature, examined
Time for a clinical trial update.
What are clinical trials?
Basically a clinical trial is a scientific research involving people, that studies the effects of a new medication, therapy or device to determine if it is safe and effective.
In the United States, clinical trials are monitored by the Food and Drug Administration.
The Phases of a Clinical Trial:
Phase I evaluates dosage parameters.
Phase II continues to evaluate safety and begins to study efficacy.
Phase III compares the new drug with standards of care or if there are none, a placebo.
Phase IV is used if the drug normally used as a standard is to be used for another condition or if the formulation is changed. This phase may also be used for extended studies on drug side effects.
Cancer clinical trials may involve studies of prevention of cancer or the treatment of cancer.
For more information see the Battling Cancer archives on the topic.
Enlight:
Participants needed for the Enlight Clinical Research Study. Researchers and doctors at medical facilities in the United States and Canada are studying two procedures in treating prostate cancer. If you are male, aged 60 or older, and have a diagnosis of low-risk, localized prostate cancer, you may qualify for this study.
The purpose of the study is to compare the safety and effectiveness of a high-intensity focused ultrasound (HIFU) procedure to cryotherapy (freeze therapy), a standard-of-care, minimally invasive treatment for prostate cancer.
More information and an online pre screening are available now.
Shark Cartilage Therapy involves the use of shark cartilage as a food supplement. Cartilage is a connective tissue. Found in the head and fins of sharks, it is ground into powder and used in capsule form. Many people prefer the enema form due to the size and taste of the capsules. It can also be injected Bovine cartilage is another type of therapy not to be confused with shark cartilage.
Shark Cartilage Therapy is considered a form of antiangiogenesis.
Antiangiogenesis or anti-angiogenesis is a type of therapy that uses pharmacology or other substances to stop cancer cells from creating new blood vessels.
Antiangiogenesis agents don’t target the cancer tumor; their focus is the blood vessels that nourish the cancer tumors, literally starving the tumors.
Dietary supplements are available and marketed as Carticin, Cartilade, and BeneFin. These supplements are not regulated by the FDA. Per NCCAM (The National Center for Complementary and Alternative Medicine) “In the United States, herbal and other dietary supplements are regulated by the U.S. Food and Drug Administration (FDA) as foods. This means that they do not have to meet the same standards as drugs and over-the-counter medications for proof of safety, effectiveness, and what the FDA calls Good Manufacturing Practices.”
In 2004 the FDA did order the manufacturers of BeneFin to stop advertising the product as a cancer cure and to refund customers.
Primary side effects of cartilage include alterations in taste.
The National Cancer Institute also reports the following side effects:
Neovastat (AE-941) is a new drug from highly purified extract of shark cartilage. Neovastat is regulated by the FDA and is not available to the public, as it is still undergoing investigative research. Used as a liquid form it may be more readily utilized by the body than other forms which are thought to be simply excreted.
What’s going on in cancer clinical trials?
For a refresher on what clinical trials are see the Battling Cancer archives on the topic.
The SUN Program: Studies to Understand Sunititrib Malate. While the there are numerous Sun Trials including five enrolling for breast cancer, this one is of particular interest. Check out the site for a video of the study on Sutent.
SUTENT is indicated for the treatment of
The FDA has given approval for a clinical trial that is all about cancer immunity. Wake Forest University School of Medicine, in Winston-Salem, North Carolina is the site of this amazing cancer research. Dr. Zheng Cui, an associate professor at the university, who teaches biochemistry, molecular biology, lipid biochemistry, cancer biology, and cancer immunology and his team will lead the trial.
The trial began with the accidental discovery of a mouse that was resistant to cancer. Repeated injection of cancer cells yielded zero tumor growth. Breeding the cancer immune mouse resulted in three of the seven grandchildren of the immune mouse also having the same immune characteristics.
Angiogenesis: blood vessel+origin. The formation of blood vessels.
Angiogenesis in cancer occurs after a rogue cell divides. In order to metastasize (spread and grow) it must move to other sites and needs nourishment from blood cells for growth. The cancer cells secrete enzymes that break down tissues and eventually secrete factors or stimulate other cells to stimulate materials that allow new blood vessels to form to keep the cancer cells nourished. In some cases these blood vessels provide a path for metastasis.
Now that you understand clinical trials, let’s see what new cancer initiatives are in progress right now.
Clinical Study Results.org is an excellent site for finding out what is going on with drug company research and provides clinical study results in a “reader friendly standardized format” to make the results for many marketed pharmaceuticals more transparent. ”
Raquel Billiones has a PhD in Biology and has over 15 years experience as a researcher, scientific English teacher, and medical writer. Since 2006, she has been a freelance WAHM specializing in medical writing and scientific documentation. More ..
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