Prevention Trials

Clinical Trials Home | Current Open Trials | Prevention Trials Institutional Review Board (IRB) | Featured Study | Staff History | Links of Interest STAR | SELECT | PREADVISE

Related Links... HEALTHWISE: Thompson Cancer Survival Center Participates in Major Breast Cancer Prevention Trial (07/05/99) HEALTHWISE: Clinical Trials Responsible for Most Advances in Cancer Treatment (07/05/99) Thompson Cancer Survival Center National Surgical Adjuvant Breast and Bowel Project (NSABP) STAR, The Study of Tamoxifen and Raloxifene The Study of Tamoxifen and Raloxifene, or STAR, one of the largest breast cancer prevention studies ever, is now recruiting volunteers at more than 400 centers across the United States, Canada, and Puerto Rico. Thompson Cancer Survival Center (TCSC) is one of the sites chosen by the study sponsor to begin immediate accrual to the trial. The trial will include 22,000 postmenopausal women at increased risk of developing breast cancer to determine whether the osteoporosis-prevention drug raloxifene (Evista) is as effective in reducing the chance of developing breast cancer as tamoxifen has been proven. Tamoxifen has been shown to reduce the chance of developing breast cancer by about half in the Breast Cancer Prevention Trial (BCPT), a study of more than 13,000 pre- and postmenopausal women at high risk of developing the disease who took either tamoxifen or a placebo for five years. TCSC was the premier site in the state of Tennessee for the BCPT and accrued over 80 women in the Knoxville area to the study. Participants taking tamoxifen also had fewer hip, wrist, and spine fractures than the women in the placebo group. However, the drug was shown to increase the women's chances of developing endometrial cancer, deep vein thrombosis (blood clot in the leg or arm), pulmonary embolism (blood clot in the lung), and possibly stroke. For this reason, women who have a history of any of these conditions should not take tamoxifen therapy. Based on the results of the study, the FDA approved the use of tamoxifen to reduce the incidence of breast cancer in high risk women in October 1998. Raloxifene was approved in December 1997 by the FDA for the prevention of osteoporosis. During the clinical trials for the drug, raloxifene was shown to reduce the risk of breast cancer in women, but it also carried an increased chance of developing blood clots--similar to the risk seen with tamoxifen. In these studies, raloxifene did not increase the risk of endometrial cancer. Women who participate in STAR must be postmenopausal, at least age 35, and have an increased risk of breast cancer as determined by their age, family history of breast cancer, personal medical history, age at first menstrual period, and age at first live birth. Once a woman chooses to participate, she will be randomly assigned to receive either tamoxifen or raloxifene daily for five years and will have regular follow-up evaluations at the Cancer Center. These include free RN-performed breast exams every six months and free lab work annually. There are also programs for economically disadvantaged women to have their annual mammogram covered, if needed. For the convenience of women in the region, STAR participants may be seen at clinics at either TCSC-downtown, the Oak Ridge Breast Center, or the Mammography Department at Fort Sanders Sevier Medical Center SELECT- Selenium and Vitamin E Cancer Prevention Trial The Selenium and Vitamin E Cancer Prevention Trial is a very important research study taking place in the United States, Puerto Rico, and Canada. SELECT is trying to find out if taking selenium and/or vitamin E supplements can prevent prostate cancer. We already have some evidence that selenium and vitamin E may be able to prevent prostate cancer, but we don't know for sure. SELECT is sponsored by the U.S. National Cancer Institute, a government agency. The study is coordinated by a group of researchers known as the Southwest Oncology Group. More than 32,00 men will take part in SELECT. Our bodies need selenium and vitamin E. We get selenium in our water and food, especially in seafood, meats, and Brazil nuts. We get vitamin E in a wide range of foods, especially vegetables, vegetable oils, nuts, and egg yolks. Selenium and vitamin E are anti-oxidants. It is believed that they help control the cell damage that can lead to cancer. Two studies that looked at preventing other cancers suggested that selenium and vitamin E might prevent prostate cancer. In a study in Finland, men who took vitamin E were less likely to get prostate cancer. But neither of those studies focused directly on prostate cancer. SELECT is the first study to look directly at the effects of selenium and/or vitamin E on the risk of prostate cancer. This study is being done to find out if selenium and/or vitamin E can really prevent prostate cancer. The amount of selenium and vitamin E used in SELECT is 200 micrograms of selenium and 400 International Units of vitamin E per day. Previous studies have shown that these amounts are safe. You may be able to participate in SELECT if: You are a man age 55 or older, or an African-American man age 50 or older. The age difference is because prostate cancer appears at younger ages in African-American men than in men of other ethnic groups. You have never had prostate cancer You have not had any other cancer for the last five years (except skin cancer) You are in generally good health If you choose to participate you will be randomized to receive either Selenium and vitamin E Vitamin E and placebo Selenium and placebo Placebo and placebo Neither you nor the researchers will know which of the capsules you are taking. You will receive the capsules free of charge. You will also receive a free bottle of multivitamin. You will need to visit the study site every 6 months to pick up new bottles of capsules and vitamin and to discuss your progress on the study. During the first year, we will contact you twice by phone to see how you are doing. The study will last for 7 to 12 years, depending on when you join. TCSC is very excited about the SELECT trial, we have currently enrolled over 50 men. As a SELECT participant, you will be a partner in medical research and may reduce your chance of getting prostate cancer. You will also have a chance to help future generations, including your sons and grandsons! For more information please contact TCSC at (865) 541-1812. PREADVISE - The Prevention of Alzheimer's Disease with Vitamin E and Selenium (PREADVISE) Prevention Study is an important addition to the Selenium and Vitamin E Cancer Prevention Trial (SELECT). The purpose of PREADVISE is to determine if taking selenium and/or vitamin E supplements can prevent Alzheimer's disease. PREADVISE is sponsored by the National Institute on Aging, a government agency. This study is coordinated by researchers at the University of Kentucky Sanders-Brown Center on Aging Alzheimer's Disease Research Center. We anticipate that more than 10,000 of the 32,000 men in SELECT will take part in PREADVISE. Selenium and/or Vitamin E may increase antioxidant defenses in the brain. Selenium, combined with vitamin E, may offer a more powerful protection from Alzheimer's Disease. No supplements or medicines have been reported as effective for Alzheimer's Disease prevention. As a PREADVISE participant, you will join in the effort to prevent Alzheimer's Disease. The supplements that you take for SELECT may also reduce your risk of getting Alzheimer's disease and other similar brain disorders. Because Alzheimer's disease can run in families, you will also have a chance to help future generations prevent this disease. Feel free to discuss PREADVISE with a nurse in the Clinical Trials Department at the TCSC. Please call (865) 541-1812.

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