A Phase 2 interventional study of preventative dietary intervention in Non-Melanomatous Skin Cancer, sponsored by Baylor College of Medicine. Status unknown at 1 site in United States. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2009-02-09.
Sponsored by Baylor College of Medicine · Phase 2, Interventional, and Prevention
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.
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.
582 studies on the registry are indexed under Skin Neoplasms; 114 are open to participants now.
This study's planned enrollment of 175 is above the median of 53 across 416 interventional studies indexed under Skin Neoplasms.
Browse Skin Neoplasms studies →Baylor College of Medicine is the lead sponsor of 734 studies on the registry; 110 are open to participants now.
Of its 83 completed or terminated interventional studies of FDA-regulated products, 44 (53%) have results posted.
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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.
This study is status unknown, as verified in Oct 2007. You cannot join it, but the record below documents what was studied.
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Baylor College of Medicine