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Skin Cancer Prophylaxis by Low-Fat Dietary Intervention

Phase 2
15 Years
Open (Enrolling)
Non-Melanomatous Skin Cancer

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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

Inclusion 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)

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

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.

Type of Study:


Study Design:

Primary Purpose: Prevention

Principal Investigator

Homer Black, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Baylor College of Medicine


United States: Federal Government

Study ID:




Start Date:

April 1989

Completion Date:

Related Keywords:

  • Non-melanomatous Skin Cancer
  • basal cell carcinoma of the skin
  • squamous cell carcinoma of the skin
  • Skin Neoplasms
  • Disease Progression



Baylor College of Medicine Houston, Texas  77030