Trial Information

Skin Cancer Prophylaxis by Low-Fat Dietary Intervention

OBJECTIVES: I. Determine whether intervention with a low-fat balanced diet will prolong the
disease-free survival time in patients presenting with nonmelanomatous skin cancer and
having a history of not more than two previous skin cancers. II. Assess the effect of this
intervention on numbers of tumors during the two year follow-up period. III. Determine the
incidence of new skin cancer in the control, nonintervention population.

OUTLINE: This is a randomized study. Patients are randomized into the Dietary Intervention
or Nonintervention groups. The control group has initial and follow up assessment of eating
habits. The dietary intervention group also has initial and follow up assessment of eating
habits that have been changed to reduce fat intake to one-half of the amount in the average
American diet with a subsequent increase of carbohydrates to compensate for total caloric
intake. Both groups have assessment of clinical status of skin cancer at 4 month intervals
for 24 months. Patients are followed for two years.

PROJECTED ACCRUAL: Approximately 175 patients will be accrued in the first 3 years of this
study.