A PHASE III TRIAL OF A LOW FAT DIET IN STAGE II BREAST C

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Breast cancer remains the primary cause of cancer death in American women. Although some improvement in morbidity and mortality has resulted from adjuvant chemotherapy in Stage II breast cancer patients, the death rate in this group is significant. This project seeks to impact further on this subset of patients by utilizing another treatment modality, nutritional intervention. The influence of dietary fat on the incidence of breast cancer has been supported by epidemiological data. Whether an increase in dietary fat intake also influences recurrence has not been investigated. However, overweight and obese women have a greater and earlier recurrence rate of breast cancer than patients of normal weight. This study investigates the influence of nutritional counseling to attain a low dietary fat intake (20% of calories) on the recurrence rate of Stage II breast cancer patients receiving adjuvant chemotherapy. Patients will be evaluated with nutritional histories and diaries prior to the institution of therapy. Accessioned patients will be randomized to control or treatment groups. Nutritional treatment will consist of both individual and group sessions which use specific techniques to encourage compliance with the restricted fat intake. Patients will be evaluated regarding fat intake monthly during the treatment period and every three months after chemotherapy is completed. Control patients will be evaluated at the same intervals. Follow-up will continue for five years or until recurrence.