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.

Condition	Treatment or Intervention	Phase
squamous cell carcinoma of the skin prevention of skin cancer basal cell carcinoma of the skin	Behavior: low fat diet	Phase II

Further Study Details: 

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.

PROTOCOL 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.

Ages Eligible for Study:  15 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically confirmed basal cell carcinoma or squamous cell carcinoma of the skin
• No more than two prior skin carcinomas
• Must not have genetic predisposition to skin cancer (i.e., xeroderma pigmentosum, basal cell nevous syndrome)

--Prior/Concurrent Therapy--

• Biologic therapy: Not specified
• Chemotherapy: Not specified
• Endocrine therapy: No concurrent systemic steroids
• Radiotherapy: No prior x-ray therapy for acne; No prior/concurrent ultraviolet light (PUVA or UVB) therapy for psoriasis
• Surgery: Not specified
• Other: No concurrent megavitamin or mineral supplementation; At least 5 years since treatment with antimetabolites, folic acid inhibitors, alkalating agents, etc.

--Patient Characteristics--

• Age: 15 and over
• Race: Caucasian
• Performance status: Not specified
• Life expectancy: Not specified
• Hematopoietic: Not specified
• Hepatic: Not specified
• Renal: Not specified
• Other: No therapeutic diet that requires fat intake greater than 20% of total calories; No untreated systemic malignancy; No history of arsenic ingestion; Not diabetic

Texas
      Baylor College of Medicine, Houston,  Texas,  77030,  United States

Study chairs or principal investigators

Homer Black,  Study Chair,  Baylor College of Medicine   

Study ID Numbers:  CDR0000065820; BCM-H-109; NCI-P97-0105
Record last reviewed:  July 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003097
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08