Selenium

 BREAST CANCER PREVENTION WITH SELENIUM IN WOMEN WITH ADH

 

Who is conducting the study?

  Chris Hawkes, Ph.D., USDAWesternHumanNutritionResearchCenter, 530-752-4765 and Shagufta Yasmeen, M.D., UC Davis School of Medicine, Obstetrics & Gynecology, 916-734-6930 are leading the study. The study is funded by the federal government and has been thoroughly reviewed and approved by the Committee for the Protection of Human Subjects.

What is the purpose of the study?

  We hope to learn if taking selenium supplements can prevent or slow down changes that might lead to breast cancer in women diagnosed with ADH or Atypical Ductal Hyperplasia.

Who can participate in the study?

  Volunteers are women who have been diagnosed with Atypical Ductal Hyperplasia or ADH, but are otherwise healthy. You must not be taking a dietary supplement containing more than 50 mcg of Selenium. You must not be allergic to yeast. You must not have had non-melanoma skin cancer.

What will you be asked to do if you participate in the study?

  You will be asked to take a pill every day for at least one year. The pills you receive may or may not contain selenium. Half of the volunteers will receive selenium and half will receive a pill without selenium, called a placebo. You will visit the Ticon-I Building at 2000 Stockton Blvd. at the UC Davis Medical Center in Sacramento 3 times during the study, requiring between 1 and 3 hours each visit.

  In addition to taking the pills, we will take a sample from inside the milk ducts in your nipples at the beginning and end of the study. A trained physician will place a very thin tube (microcatheter) into the openings of your nipple's milk ducts and rinse gently with salt water to remove cells from the inside of the ducts, a procedure called "ductal lavage". An anesthetic cream is applied to your nipple and covered with a dressing about one hour before the procedure. A small amount of local anesthetic is pushed inside the milk duct, then several small portions of salt water are used to rinse out the inside. This is repeated on each duct opening on each nipple. One to three samples are usually obtained from each person.

  We will measure your weight, height, waist circumference, and hip circumference, and you will fill out a food frequency questionnaire and a health history questionnaire, at the beginning and end of the study.A trained medical staff person will collect blood samples from a vein in your arm (venipuncture) 3 times during the study. We will take no more than 4 tablespoons (4 oz.) of blood each time, in the morning before you've eaten following an overnight fast lasting 12 hours. The total amount of blood taken during the first year of the study (about one-half cup) will be less than what blood donors are allowed to safely give at one time.

What are the benefits to you from this study?

  You will earn $25 for completing each clinic visit.

  You will receive a computerized nutrition report.

  You will have the opportunity to see how scientific research is conducted.

What should I do if I have more questions?

  We have many staff people to assist you. If you have any questions, please call Evelyn Holguin at 530-754-5735 or Ellen Bonnel 530-752-4184.