Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Houston, Texas 77030


Purpose:

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.


Study summary:

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.


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.


NCT ID:

NCT00003097


Primary Contact:

Study Chair
Homer Black, PhD
Baylor College of Medicine


Backup Contact:

N/A


Location Contact:

Houston, Texas 77030
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 25, 2017

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.