WOMEN'S HEALTHY EATING AND LIVING TRIAL IN THE BAY AREA

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Evidence suggests that regression and progression of localized breast cancer, after the disease has been diagnosed and treated by conventional means, might be reduced by 30-50% if current dietary guidelines for Americans were enriched markedly for edible plants and fiber and had a reduced fat content. The Women's Healthy Eating and Living (WHEL) study, a 6-yr multicenter randomized trial of 3,104 cancer survivors, is comparing the effect of receiving instruction on the dietary guidelines of the National Cancer Institute (NCI), i.e. <30% of calories from fat, = 5 servings/day of fruits and vegetables, = 6 servings/day of grains with a dietary counseling program which has the following dietary goals: 15-20% of calories from total fat, = 30 gm of fiber/day, = 5 servings of vegetables plus 16 oz/day of vegetable juice, with an emphasis on "nutrient-dense" vegetables, i.e. those with a high content of antioxidants and specific phytochemicals , and = 3 servings/day of fruit. WHEL Study participants were within 4 yrs of their diagnosis of stage I (>1 cm), II, and IIIA disease and had completed conventional therapy. The Northern California Cancer Center, one of six clinical centers, enrolled 517 women, 355 of whom are being tested and followed at the Stanford GCRC. In addition to telephone counseling by USCD Coordinating Center staff, participants attend regular cooking classes at the GCRC, which are directed by registered dietitians who also provide interim counseling. Medical follow-up is by usual oncology practice to determine clinical study endpoints of disease-free and total survival. WHEL will determine if the risk of recurrence can be reduced in the diet-intervention group by 20%, versus the NCI-diet control group, at 6 yrs. To gain insight into mechanisms of how diet might influence the disease, WHEL is comparing plasma carotinoids and endogenous estrogen levels in women who have a secondary cancer event with levels in women whose cancers have not yet recurred, but who are matched for other characteristics from both the study and control groups.