PHILADELPHIAThe Women’s Intervention Nutrition Study
(WINS) has completed accrual, with some 2,400 women enrolled to date. The
study, an NCI-funded, randomized, multicenter national trial begun in 1993, is
testing the hypothesis that dietary fat intake reduction as an adjuvant to
standard breast cancer therapy will reduce disease recurrence and increase
survival in women with localized breast cancer.
The researchers have been able to accrue the required
population of breast cancer patients and maintain sufficient dietary adherence
in the intervention group to meet the goals of the study. Patients will be
followed for 4 more years, according to Barbara Winters, PhD, RD,
coinvestigator and coordinator of the WINS trial for the American Health
Dr. Winters described the study and its progress at the annual
meeting of the Society for Nutritional Oncology Adjuvant Therapy (NOAT).
"What we’ve done is taken basic science and
epidemiologic findings that were positive and moved them forward to a clinical
trial. The essentials are competent, involved nutritionists, the interest of
the physician, and the ‘dose,’ which is the quality of counseling, its
intensity and duration," Dr. Winters said.
Intensive Dietary Intervention
According to the protocol, the experimental group receives
intensive dietary interventions: individual and group counseling sessions aimed
at reducing the participants’ total fat intake to 15% of their daily caloric
intake (20 to 30 g/d, depending on the woman’s weight).
The control group receives USDA/DHHS dietary guidelines and
Of the women enrolled, 85% are white, 6% are black, 5.6% are
Hispanic, 3.2% are Asian, and 1.2% Native American.
To be eligible for the study, women must be between 48 and 78
years old and have histologically proven, invasive, localized carcinoma of the
I/II/IIIA disease. They are randomized within 1 year of diagnosis to the
fat-intake intervention group or to the control group. All of the patients who
are estrogen-receptor positive receive concurrent hormonal therapy.
Long-term adherence strategies include individualized
assessment of needs with booster sessions, researchers part-nering with
participants, and publishing newsletters with articles addressing the concerns
of the participants.
Dietary adherence is assessed with serial unannounced telephone
calls by trained interviewers who are not the nutritionists who work with
patients one on one.
The WINS study is not aimed at weight loss, Dr. Winters said,
although women in the intervention arm of the study typically lose about 3.3 lb
in their first year on the trial. The control group gains about 1 lb a year,
which is to be expected in this age group.
The researchers are also looking at how their recommendations
translate into actual food intake. Recommendations for six servings of bread
daily, for example, are not quite matched by either group, she said. Data on
supplement use are also being compiled. Eighty percent of the participants used
some supplement at baseline.
The aim of the study is to provide a definitive evaluation of
the effect of dietary fat intake on breast cancer patient outcome, Dr. Winters