A RANDOMIZED TRIAL OF A LOW-FAT DIETARY INTERVENTION IN WOMEN AT HIGH-RISK FOR BREAST-CANCER

A randomized intervention trial of dietary fat reduction to 15% of tot al calories was initiated in 1987 for women at high risk for bl-east c ancer to determine the feasibility of recruiting and maintaining them on a low-fat diet. The study has enrolled 194 women between the ages o f 18 and 67 years who met at least one of three eligibility criteria: 1) a first-degree relative with breast cancer, 2) a P2 or DY Wolfe mam mographic pattern, and 3) a prior breast biopsy demonstrating epitheli al hyperplasia with or without atypia. Eligible women must also have h ad diets that contained greater than or equal to 30% of calories from fat at entry. Women were randomized to a nonintervention usual diet vs . a 15% few-fat diet. Recruitment was sought through physicians, perso nal mailings, breast cancer patients, and the news media. Two study si tes participated: a large urban hospital affiliated with a university medical center and a community oncology private practice. The results from both institutions were similar and demonstrated that a low-fat di etary plan could be effectively conducted in private as well as academ ic settings with recruitment tailored to the community where the trial is being conducted. Reduction in dietary fat intake was maximal durin g the first threes months of the dietary intervention and remained sta ble throughout 12 months of follow-up. Reductions in total calories, w eight loss, and percent body fat were minimal, The nonintervention gro up experienced no major change in their diet. We conclude that it is f easible to recruit women who are at high risk for breast cancer into a dietary intervention trial, and with sufficient dietary counseling an d motivation on the parr of participants, reduction in dietary fat int ake can be achieved and maintained. More in-depth analyses of these da ta will be presented in subsequent reports.