NCT00003097

Low Fat Diet to Prevent Disease Progression in Patients With Skin Cancer

Skin Cancer Prophylaxis by Low-Fat Dietary Intervention

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 175 (estimated)
• Sponsor: Baylor College of Medicine · Academic / Other
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: A low-fat, balanced diet may prevent disease progression in patients with nonmelanomatous skin cancer. PURPOSE: Randomized phase II trial to study the effectiveness of a low-fat, balanced diet to prevent disease progression in patients with nonmelanomatous skin cancer.

Detailed description

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.

Conditions

• Non-Melanomatous Skin Cancer

Interventions

Type	Name	Description
OTHER	preventative dietary intervention

Timeline

• Start date: 1989-04-01
• First posted: 2004-08-02
• Last updated: 2009-02-09

Locations

1 site across 1 country: United States