Fifty-one women from the local area are participating in the nationwide Breast Cancer Prevention Trial through the Dartmouth Hitchcock Medical Center.
The study, which began in June 1992 in an effort to test the drug tamoxifen for its effectiveness in preventing breast cancer, has now enrolled 8,000 women throughout the U.S., half of those needed to complete the study.
Tamoxifen has been used for more than 20 years with breast cancer patients both in the earlier and later stages, but has never been tried as a preventive measure.
"Physical checkups and mammograms have been the only preventive methods until now," Dr. Jonathan Ross, the principal investigator of the trial, said. "We need better preventive measures in order to do something about the epidemic of breast cancer in this country."
Tamoxifen has been proven in earlier studies to reduce the chances of breast cancer by 30 to 40 percent and to reduce the chances of heart attacks and heart disease by 20 to 25 percent by lowering cholesterol and preventing osteoporosis.
"Depending on the age of the woman, the benefits are different," Ross said. "In the younger group it is more for breast cancer prevention while for the older women it is for the prevention of heart attacks, heart disease and osteoporosis."
DHMC has advertised on radio, television and in newspapers informing women of the study and asking for volunteers. It has also notified many primary care specialists and gynecologists, alerting them to the study and asking for recommendations, according to Ross.
The women participating in the trial are aged 35 and older and are at an increased risk for developing breast cancer, based on a formula set by the National Surgical Adjuvant Breast and Bowel Project at the University of Pittsburgh, which is conducting the nationwide trial.
The risk of breast cancer is determined by the chance a woman has of contracting the disease by the age of 80. All women age 60-78 are eligible for the trial. The lower the age of the woman, the higher her risk must be in order to be accepted into the trial.
Once accepted, the women are randomly divided into two groups, half taking tamoxifen and half a placebo on a daily basis for five years. Neither the women nor the doctor knows which of the two the participant is taking. Ross said that this ensures that all side effects are noticed.
"In a similar study 45 percent of women taking the placebo experienced hot flashes and 62 percent of the women taking tamoxifen also had hot flashes," Ross said, explaining the importance of the double-blind study.
The women are monitored very closely, visiting with the doctor after the first month, then after three months and then after six months as well as every six months thereafter. On their visits they are asked to fill out a questionnaire about side effects, quality of life and symptoms. The women also get a physical examination that may include blood tests. Once a year they also have a mammogram and a gynecological exam.
"They are getting as much prevention as they possibly can aside from the drug," Ross said. "Many women know that mammograms are recommended after a certain age on a yearly basis, but when we looked at the statistics of who is getting screened, statistics show that fewer women than should are doing it."
While the tamoxifen and doctor visits are free of charge, there may be laboratory costs. "We are trying to make it a free study, but we can't say that because any costs [the women] may incur will have to be paid for," Ross said. "It is at minimal cost to the patient."
By the end of June, the NSABP had involved 309 cancer clinics and hospitals across the United States and Canada and over 8,300 women in the study. NSABP closely monitors the activities of the clinics and hospitals as well as the women involved in the trial.
"We have seen no serious side effects or drug reactions," Lori Psillidis, a communication specialist with NSABP, said. "The medication has been very well tolerated." The trial, which is the first of its kind in the world, is primarily funded by the National Cancer Institute.
